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#71
Research / We need to talk about the arti...
Last post by mensfe_admin - 2019-10-16 09:1614 October 2019 - by Elizabeth Chloe Romanis
This week, researchers based at the University of Technology in Eindhoven announced they had received Horizon 2020 funding to build their artificial womb prototype (see this week's news article). This follows the news, in 2017 (see BioNews 898) and again in 2019, of successful animal testing of artificial womb prototypes, named the Biobag and the EVE Platform, in the USA and Australia. This latest development towards the artificial womb improves the prospects of the technology coming to fruition. The race to develop the artificial womb is on!
Artificial womb technology is sought after as a means of circumventing the inherent limitations and problems of neonatal intensive care. Around one in 13 pregnancies in the UK are delivered prematurely, and a significant number of preterm babies require intensive care. The prospects for premature neonates have improved over the last few decades thanks to developments in mechanical ventilation and substances that help babies' lungs better receive oxygen. However, babies born at or below 24 weeks are still unlikely to survive, and those born before 26 weeks are at risk of serious long-term health problems.
Neonatal intensive care only supports babies that are born functionally mature enough to withstand ventilation, so intensive care appears to have reached a natural limit at 22 weeks. Before this point a fetus usually has not developed solid lungs, so they cannot be assisted. There are also common complications associated with the interventions given in intensive care – in particular damage to the babies' lungs from ventilation and infections from feeding tubes.
The artificial womb marks a shift in approach to treating preterms: away from intrusive attempts to provide mechanical assistance to a preterm struggling to sustain itself and towards attempting to support development by continuing gestation extra uterum. The devices being created endeavour to better mimic the environment of the uterus by sealing the preterm in amniotic fluid, administering essential nutrients through a cannula emulating an umbilical cord and using an oxygenator to assist the preterm in maintaining its own heartbeat. By providing the conditions for gestation, the preterm is able to continue growing and maturing as if the pregnancy had not ended.
It is thought that this approach could almost eliminate deaths due to prematurity (because they are not subject to the same constraints of lung maturity), and prevent the occurrence of the long-term health problems caused by common complications in neonatal intensive care. The artificial womb is also a welcome development to avoid parent(s) experiencing the devastation that often results from preterm birth. In addition, the technology could also save the lives (and health) of pregnant people by taking over gestation if pregnancy becomes dangerous.
In the future, artificial wombs could enable gestation to become a reproductive choice, by potentially allowing people to choose how long they want to be pregnant for. It might even come to be seen as an alternative fertility treatment, alongside uterus transplants and surrogacy, for persons unable to carry a full pregnancy. At this point these benefits are all speculative – but it is easy to see why scientists are so keen to develop this technology.
The Biobag team, based in the US, anticipate that their artificial womb device might be ready for human testing in just 5 years' time. The Eindhoven researchers suggest they might have a prototype ready for use in hospitals in the same time frame. With researchers working so quickly and with the potential consequences of the artificial womb so broad and unknown, we need to think carefully now about the legal and ethical implications of the technology in advance of its development. These problems and questions it raises are both intricate and wide-ranging.
For example, what kind of human entity is the subject of the artificial womb? It is more similar (in behaviour, features and the extent of its dependency) to a fetus than a newborn (that has to adapt to the external environment and take on some of the burden of sustaining itself). I have argued the subject of an artificial womb is a unique entity; we have never known a human entity undergoing the process of gestation extra uterum before. I've termed it a 'gestateling.' The law (at least in England and Wales) treats a fetus and a newborn very differently, so determining the recognition and legal protections that are, or should be, afforded to a gestateling, are complicated questions in need of an answer.
There are also other pressing issues related to the clinical translation of these devices from concept, design and animal experiments to a replacement for neonatal intensive care in clinics. How and when might it be ethical to test these devices on humans? Is it more ethical to test it on preterms so premature they have no chance of surviving in intensive care, or only those more mature that we know (based on clinical data in intensive care) to have some chance of survival? There are also uncertainties associated with the potential long-term consequences of being partially gestated by machine compared to a person.
What is most interesting about the recent announcements from Eindhoven, especially in comparison to the ongoing experiments in the USA and Australia, is the focus they seem to be placing on 'uterine experience' in developing their prototype. Professor Guid Oei and his team are not just interested in successfully emulating the processes involved in gestation, but also some of the relational aspects. Professor Oei emphasises that their artificial womb will not just be a 'plastic bag' but an environment in which the gestateling can 'feel, and see, and smell, and hear the same sounds as when they are in the womb...' Whether the relationship between a pregnant person and their fetus is even something that can be artificially replicated remains to be seen.
One thing that is clear, however, is that practical questions about a functioning and experimental artificial womb, once thought to be entirely hypothetical, are very deserving of our attention.
This week, researchers based at the University of Technology in Eindhoven announced they had received Horizon 2020 funding to build their artificial womb prototype (see this week's news article). This follows the news, in 2017 (see BioNews 898) and again in 2019, of successful animal testing of artificial womb prototypes, named the Biobag and the EVE Platform, in the USA and Australia. This latest development towards the artificial womb improves the prospects of the technology coming to fruition. The race to develop the artificial womb is on!
Artificial womb technology is sought after as a means of circumventing the inherent limitations and problems of neonatal intensive care. Around one in 13 pregnancies in the UK are delivered prematurely, and a significant number of preterm babies require intensive care. The prospects for premature neonates have improved over the last few decades thanks to developments in mechanical ventilation and substances that help babies' lungs better receive oxygen. However, babies born at or below 24 weeks are still unlikely to survive, and those born before 26 weeks are at risk of serious long-term health problems.
Neonatal intensive care only supports babies that are born functionally mature enough to withstand ventilation, so intensive care appears to have reached a natural limit at 22 weeks. Before this point a fetus usually has not developed solid lungs, so they cannot be assisted. There are also common complications associated with the interventions given in intensive care – in particular damage to the babies' lungs from ventilation and infections from feeding tubes.
The artificial womb marks a shift in approach to treating preterms: away from intrusive attempts to provide mechanical assistance to a preterm struggling to sustain itself and towards attempting to support development by continuing gestation extra uterum. The devices being created endeavour to better mimic the environment of the uterus by sealing the preterm in amniotic fluid, administering essential nutrients through a cannula emulating an umbilical cord and using an oxygenator to assist the preterm in maintaining its own heartbeat. By providing the conditions for gestation, the preterm is able to continue growing and maturing as if the pregnancy had not ended.
It is thought that this approach could almost eliminate deaths due to prematurity (because they are not subject to the same constraints of lung maturity), and prevent the occurrence of the long-term health problems caused by common complications in neonatal intensive care. The artificial womb is also a welcome development to avoid parent(s) experiencing the devastation that often results from preterm birth. In addition, the technology could also save the lives (and health) of pregnant people by taking over gestation if pregnancy becomes dangerous.
In the future, artificial wombs could enable gestation to become a reproductive choice, by potentially allowing people to choose how long they want to be pregnant for. It might even come to be seen as an alternative fertility treatment, alongside uterus transplants and surrogacy, for persons unable to carry a full pregnancy. At this point these benefits are all speculative – but it is easy to see why scientists are so keen to develop this technology.
The Biobag team, based in the US, anticipate that their artificial womb device might be ready for human testing in just 5 years' time. The Eindhoven researchers suggest they might have a prototype ready for use in hospitals in the same time frame. With researchers working so quickly and with the potential consequences of the artificial womb so broad and unknown, we need to think carefully now about the legal and ethical implications of the technology in advance of its development. These problems and questions it raises are both intricate and wide-ranging.
For example, what kind of human entity is the subject of the artificial womb? It is more similar (in behaviour, features and the extent of its dependency) to a fetus than a newborn (that has to adapt to the external environment and take on some of the burden of sustaining itself). I have argued the subject of an artificial womb is a unique entity; we have never known a human entity undergoing the process of gestation extra uterum before. I've termed it a 'gestateling.' The law (at least in England and Wales) treats a fetus and a newborn very differently, so determining the recognition and legal protections that are, or should be, afforded to a gestateling, are complicated questions in need of an answer.
There are also other pressing issues related to the clinical translation of these devices from concept, design and animal experiments to a replacement for neonatal intensive care in clinics. How and when might it be ethical to test these devices on humans? Is it more ethical to test it on preterms so premature they have no chance of surviving in intensive care, or only those more mature that we know (based on clinical data in intensive care) to have some chance of survival? There are also uncertainties associated with the potential long-term consequences of being partially gestated by machine compared to a person.
What is most interesting about the recent announcements from Eindhoven, especially in comparison to the ongoing experiments in the USA and Australia, is the focus they seem to be placing on 'uterine experience' in developing their prototype. Professor Guid Oei and his team are not just interested in successfully emulating the processes involved in gestation, but also some of the relational aspects. Professor Oei emphasises that their artificial womb will not just be a 'plastic bag' but an environment in which the gestateling can 'feel, and see, and smell, and hear the same sounds as when they are in the womb...' Whether the relationship between a pregnant person and their fetus is even something that can be artificially replicated remains to be seen.
One thing that is clear, however, is that practical questions about a functioning and experimental artificial womb, once thought to be entirely hypothetical, are very deserving of our attention.
#72
General Discussion / We need to talk about the arti...
Last post by mensfe_admin - 2019-10-16 09:1514 October 2019 - by Elizabeth Chloe Romanis
This week, researchers based at the University of Technology in Eindhoven announced they had received Horizon 2020 funding to build their artificial womb prototype (see this week's news article). This follows the news, in 2017 (see BioNews 898) and again in 2019, of successful animal testing of artificial womb prototypes, named the Biobag and the EVE Platform, in the USA and Australia. This latest development towards the artificial womb improves the prospects of the technology coming to fruition. The race to develop the artificial womb is on!
Artificial womb technology is sought after as a means of circumventing the inherent limitations and problems of neonatal intensive care. Around one in 13 pregnancies in the UK are delivered prematurely, and a significant number of preterm babies require intensive care. The prospects for premature neonates have improved over the last few decades thanks to developments in mechanical ventilation and substances that help babies' lungs better receive oxygen. However, babies born at or below 24 weeks are still unlikely to survive, and those born before 26 weeks are at risk of serious long-term health problems.
Neonatal intensive care only supports babies that are born functionally mature enough to withstand ventilation, so intensive care appears to have reached a natural limit at 22 weeks. Before this point a fetus usually has not developed solid lungs, so they cannot be assisted. There are also common complications associated with the interventions given in intensive care – in particular damage to the babies' lungs from ventilation and infections from feeding tubes.
The artificial womb marks a shift in approach to treating preterms: away from intrusive attempts to provide mechanical assistance to a preterm struggling to sustain itself and towards attempting to support development by continuing gestation extra uterum. The devices being created endeavour to better mimic the environment of the uterus by sealing the preterm in amniotic fluid, administering essential nutrients through a cannula emulating an umbilical cord and using an oxygenator to assist the preterm in maintaining its own heartbeat. By providing the conditions for gestation, the preterm is able to continue growing and maturing as if the pregnancy had not ended.
It is thought that this approach could almost eliminate deaths due to prematurity (because they are not subject to the same constraints of lung maturity), and prevent the occurrence of the long-term health problems caused by common complications in neonatal intensive care. The artificial womb is also a welcome development to avoid parent(s) experiencing the devastation that often results from preterm birth. In addition, the technology could also save the lives (and health) of pregnant people by taking over gestation if pregnancy becomes dangerous.
In the future, artificial wombs could enable gestation to become a reproductive choice, by potentially allowing people to choose how long they want to be pregnant for. It might even come to be seen as an alternative fertility treatment, alongside uterus transplants and surrogacy, for persons unable to carry a full pregnancy. At this point these benefits are all speculative – but it is easy to see why scientists are so keen to develop this technology.
The Biobag team, based in the US, anticipate that their artificial womb device might be ready for human testing in just 5 years' time. The Eindhoven researchers suggest they might have a prototype ready for use in hospitals in the same time frame. With researchers working so quickly and with the potential consequences of the artificial womb so broad and unknown, we need to think carefully now about the legal and ethical implications of the technology in advance of its development. These problems and questions it raises are both intricate and wide-ranging.
For example, what kind of human entity is the subject of the artificial womb? It is more similar (in behaviour, features and the extent of its dependency) to a fetus than a newborn (that has to adapt to the external environment and take on some of the burden of sustaining itself). I have argued the subject of an artificial womb is a unique entity; we have never known a human entity undergoing the process of gestation extra uterum before. I've termed it a 'gestateling.' The law (at least in England and Wales) treats a fetus and a newborn very differently, so determining the recognition and legal protections that are, or should be, afforded to a gestateling, are complicated questions in need of an answer.
There are also other pressing issues related to the clinical translation of these devices from concept, design and animal experiments to a replacement for neonatal intensive care in clinics. How and when might it be ethical to test these devices on humans? Is it more ethical to test it on preterms so premature they have no chance of surviving in intensive care, or only those more mature that we know (based on clinical data in intensive care) to have some chance of survival? There are also uncertainties associated with the potential long-term consequences of being partially gestated by machine compared to a person.
What is most interesting about the recent announcements from Eindhoven, especially in comparison to the ongoing experiments in the USA and Australia, is the focus they seem to be placing on 'uterine experience' in developing their prototype. Professor Guid Oei and his team are not just interested in successfully emulating the processes involved in gestation, but also some of the relational aspects. Professor Oei emphasises that their artificial womb will not just be a 'plastic bag' but an environment in which the gestateling can 'feel, and see, and smell, and hear the same sounds as when they are in the womb...' Whether the relationship between a pregnant person and their fetus is even something that can be artificially replicated remains to be seen.
One thing that is clear, however, is that practical questions about a functioning and experimental artificial womb, once thought to be entirely hypothetical, are very deserving of our attention.
This week, researchers based at the University of Technology in Eindhoven announced they had received Horizon 2020 funding to build their artificial womb prototype (see this week's news article). This follows the news, in 2017 (see BioNews 898) and again in 2019, of successful animal testing of artificial womb prototypes, named the Biobag and the EVE Platform, in the USA and Australia. This latest development towards the artificial womb improves the prospects of the technology coming to fruition. The race to develop the artificial womb is on!
Artificial womb technology is sought after as a means of circumventing the inherent limitations and problems of neonatal intensive care. Around one in 13 pregnancies in the UK are delivered prematurely, and a significant number of preterm babies require intensive care. The prospects for premature neonates have improved over the last few decades thanks to developments in mechanical ventilation and substances that help babies' lungs better receive oxygen. However, babies born at or below 24 weeks are still unlikely to survive, and those born before 26 weeks are at risk of serious long-term health problems.
Neonatal intensive care only supports babies that are born functionally mature enough to withstand ventilation, so intensive care appears to have reached a natural limit at 22 weeks. Before this point a fetus usually has not developed solid lungs, so they cannot be assisted. There are also common complications associated with the interventions given in intensive care – in particular damage to the babies' lungs from ventilation and infections from feeding tubes.
The artificial womb marks a shift in approach to treating preterms: away from intrusive attempts to provide mechanical assistance to a preterm struggling to sustain itself and towards attempting to support development by continuing gestation extra uterum. The devices being created endeavour to better mimic the environment of the uterus by sealing the preterm in amniotic fluid, administering essential nutrients through a cannula emulating an umbilical cord and using an oxygenator to assist the preterm in maintaining its own heartbeat. By providing the conditions for gestation, the preterm is able to continue growing and maturing as if the pregnancy had not ended.
It is thought that this approach could almost eliminate deaths due to prematurity (because they are not subject to the same constraints of lung maturity), and prevent the occurrence of the long-term health problems caused by common complications in neonatal intensive care. The artificial womb is also a welcome development to avoid parent(s) experiencing the devastation that often results from preterm birth. In addition, the technology could also save the lives (and health) of pregnant people by taking over gestation if pregnancy becomes dangerous.
In the future, artificial wombs could enable gestation to become a reproductive choice, by potentially allowing people to choose how long they want to be pregnant for. It might even come to be seen as an alternative fertility treatment, alongside uterus transplants and surrogacy, for persons unable to carry a full pregnancy. At this point these benefits are all speculative – but it is easy to see why scientists are so keen to develop this technology.
The Biobag team, based in the US, anticipate that their artificial womb device might be ready for human testing in just 5 years' time. The Eindhoven researchers suggest they might have a prototype ready for use in hospitals in the same time frame. With researchers working so quickly and with the potential consequences of the artificial womb so broad and unknown, we need to think carefully now about the legal and ethical implications of the technology in advance of its development. These problems and questions it raises are both intricate and wide-ranging.
For example, what kind of human entity is the subject of the artificial womb? It is more similar (in behaviour, features and the extent of its dependency) to a fetus than a newborn (that has to adapt to the external environment and take on some of the burden of sustaining itself). I have argued the subject of an artificial womb is a unique entity; we have never known a human entity undergoing the process of gestation extra uterum before. I've termed it a 'gestateling.' The law (at least in England and Wales) treats a fetus and a newborn very differently, so determining the recognition and legal protections that are, or should be, afforded to a gestateling, are complicated questions in need of an answer.
There are also other pressing issues related to the clinical translation of these devices from concept, design and animal experiments to a replacement for neonatal intensive care in clinics. How and when might it be ethical to test these devices on humans? Is it more ethical to test it on preterms so premature they have no chance of surviving in intensive care, or only those more mature that we know (based on clinical data in intensive care) to have some chance of survival? There are also uncertainties associated with the potential long-term consequences of being partially gestated by machine compared to a person.
What is most interesting about the recent announcements from Eindhoven, especially in comparison to the ongoing experiments in the USA and Australia, is the focus they seem to be placing on 'uterine experience' in developing their prototype. Professor Guid Oei and his team are not just interested in successfully emulating the processes involved in gestation, but also some of the relational aspects. Professor Oei emphasises that their artificial womb will not just be a 'plastic bag' but an environment in which the gestateling can 'feel, and see, and smell, and hear the same sounds as when they are in the womb...' Whether the relationship between a pregnant person and their fetus is even something that can be artificially replicated remains to be seen.
One thing that is clear, however, is that practical questions about a functioning and experimental artificial womb, once thought to be entirely hypothetical, are very deserving of our attention.
#73
General Discussion / PLEASE NOTE WE DO NOT GIVE MED...
Last post by mensfe_admin - 2019-02-19 15:59MENSFE WILL NOT GIVE A DIAGNOSIS FOR A MEDICAL CONDITION
WE STRONGLY RECOMEND THAT ANYONE SUFFERING FROM THE ABOVE PLEASE CONTACT YOUR GP.
AND - OR REFER TO A CLINICAL SPECIALIST.
GOOD LOOK
WE STRONGLY RECOMEND THAT ANYONE SUFFERING FROM THE ABOVE PLEASE CONTACT YOUR GP.
AND - OR REFER TO A CLINICAL SPECIALIST.
GOOD LOOK
#74
General Discussion / In Defence of Women
Last post by mensfe_admin - 2018-11-24 10:5312 November 2018 - by Dr Geeta Nargund, Professor Stuart Campbell, Dr Svend Lindenberg, Dr Pasquale Patrizio, Professor Rene Frydman
Over the last ten years, the International Society for Mild Approaches in Assisted Reproduction (ISMAAR) has campaigned worldwide to put the welfare of women at the heart of fertility treatment.
IVF has been transformed over the last 40 years. One of the most startling changes is that a treatment which was originally intended to address the problem of tubal infertility is now regularly used to treat women who are both healthy and fertile. From male factor infertility, to elective egg freezing or same-sex couples wishing to start a family, the contexts of our practice have been irreversibly changed. These should rightly be regarded as advances, but with every step forward, we have an increasing responsibility to ensure that no healthy woman is made ill from fertility treatment.
Women undergoing IVF can experience a wide range of side effects, the most serious of which is Ovarian Hyperstimulation Syndrome (OHSS). In its mild form this affects as many as one third of cycles, with 3.1 to 8 percent being moderately or severely affected, according to the Royal College of Obstetricians and Gynaecologists.
Research has shown that if more than 15 eggs are collected during one cycle, women are at increased risk of OHSS without any increase in IVF success rates. The data from the Human Fertilisation and Embryology Authority (HFEA), released in response to parliamentary questions by MP Siobhain McDonagh between April to June 2018, revealed that between 2013 and 2017, 20 or more eggs were collected in 21,244 cycles, approximately 6.5 percent of total cycles in that period. Further, in 1860 cycles, more than 30 eggs and in some cases more than 50 eggs were collected in a single cycle.
At the same time, NHS data has recorded 836 emergency hospital admissions as a result of OHSS in a single year; a stark difference to the 60 cases reported directly to the HFEA. The true picture about hospital admissions can only be obtained if we link the HFEA registry with that of the NHS registry as is done in Scandinavia, Australia, USA and many other countries.
OHSS is often presented to women as a 'no pain, no gain' reality, yet it must be at least presented to patients that OHSS is a largely preventable condition and that the mild stimulation IVF treatment strategy delivers equivalent success rates per cycle while significantly reducing the risk of OHSS.
The aim of conventional IVF is to stimulate the ovaries to maximise the egg numbers, while in mild IVF, the aim is to obtain a mild response that will produce an adequate number of quality eggs to produce equivalent success rates. If the ideal number of eggs per live birth with conventional IVF in women with normal ovarian reserve is 15, with mild IVF it is about half that number and can be as few as five. The battle lines are drawn squarely between quantity and quality.
Statements that there is 'little doubt' that the conventional approach gives a woman a 'significantly better chance' must be challenged (see BioNews 973). The classic paper by Valerie Baker and colleagues who studied over 650,000 consecutive cycles from the American Society of Reproductive Medicine database demonstrated that there was an inverse relationship between the stimulating dose of follicle stimulating hormone and live birth throughout all age groups, including among women under the age of 35.
There are numerous papers confirming that mild IVF gives comparable success rates in terms of live births as conventional IVF. At present there is no large randomised study directly comparing the two methods, but that does not justify defenestrating the significant body of evidence demonstrating equivalence of success rates. This is not to mention the significant benefits that mild IVF brings in relation to health outcomes for women and children, and reduction in the burden of both treatment and the total cost.
The number of eggs collected per cycle in the UK is increasing annually with the risk of OHSS contained by the use of agonist trigger and 'freeze-all embryos' in the case of high oestradiol levels. While this strategy is an important emergency tool in reducing OHSS complications, it is not prevention and it should not be taken as a licence to ignore the dangers of ovarian stimulation, nor subjecting women to the concomitant side effects. True prevention is not placing women at OHSS risk in the first place by avoiding aggressive protocols of ovarian stimulation.
It must always be remembered that the protection of the welfare of women in IVF is a wider concept beyond OHSS prevention. There are additional treatments, such as the administration of intravenous immunology drugs, which may have potentially harmful effects and are in desperate need of more oversight. At present, lack of data collection and database linkage restrictions are obscuring our ability to determine the size of problem.
Instead of large-scale, rigorous analysis, we are often given bland reassurances that all is well with the state of IVF in the UK. Sensible proposals to protect the welfare of women are currently being put forward in Parliament by McDonagh and should be supported whatever one's view on the best stimulation strategy.
We surely all agree that the aim of IVF treatment should be to achieve a singleton, healthy, full term, normal weight baby, without putting a woman's health at risk in the short or long term. With the additional oversight and data, we will be able to speak confidently as one voice that we are protecting the welfare of women during IVF treatment.
Over the last ten years, the International Society for Mild Approaches in Assisted Reproduction (ISMAAR) has campaigned worldwide to put the welfare of women at the heart of fertility treatment.
IVF has been transformed over the last 40 years. One of the most startling changes is that a treatment which was originally intended to address the problem of tubal infertility is now regularly used to treat women who are both healthy and fertile. From male factor infertility, to elective egg freezing or same-sex couples wishing to start a family, the contexts of our practice have been irreversibly changed. These should rightly be regarded as advances, but with every step forward, we have an increasing responsibility to ensure that no healthy woman is made ill from fertility treatment.
Women undergoing IVF can experience a wide range of side effects, the most serious of which is Ovarian Hyperstimulation Syndrome (OHSS). In its mild form this affects as many as one third of cycles, with 3.1 to 8 percent being moderately or severely affected, according to the Royal College of Obstetricians and Gynaecologists.
Research has shown that if more than 15 eggs are collected during one cycle, women are at increased risk of OHSS without any increase in IVF success rates. The data from the Human Fertilisation and Embryology Authority (HFEA), released in response to parliamentary questions by MP Siobhain McDonagh between April to June 2018, revealed that between 2013 and 2017, 20 or more eggs were collected in 21,244 cycles, approximately 6.5 percent of total cycles in that period. Further, in 1860 cycles, more than 30 eggs and in some cases more than 50 eggs were collected in a single cycle.
At the same time, NHS data has recorded 836 emergency hospital admissions as a result of OHSS in a single year; a stark difference to the 60 cases reported directly to the HFEA. The true picture about hospital admissions can only be obtained if we link the HFEA registry with that of the NHS registry as is done in Scandinavia, Australia, USA and many other countries.
OHSS is often presented to women as a 'no pain, no gain' reality, yet it must be at least presented to patients that OHSS is a largely preventable condition and that the mild stimulation IVF treatment strategy delivers equivalent success rates per cycle while significantly reducing the risk of OHSS.
The aim of conventional IVF is to stimulate the ovaries to maximise the egg numbers, while in mild IVF, the aim is to obtain a mild response that will produce an adequate number of quality eggs to produce equivalent success rates. If the ideal number of eggs per live birth with conventional IVF in women with normal ovarian reserve is 15, with mild IVF it is about half that number and can be as few as five. The battle lines are drawn squarely between quantity and quality.
Statements that there is 'little doubt' that the conventional approach gives a woman a 'significantly better chance' must be challenged (see BioNews 973). The classic paper by Valerie Baker and colleagues who studied over 650,000 consecutive cycles from the American Society of Reproductive Medicine database demonstrated that there was an inverse relationship between the stimulating dose of follicle stimulating hormone and live birth throughout all age groups, including among women under the age of 35.
There are numerous papers confirming that mild IVF gives comparable success rates in terms of live births as conventional IVF. At present there is no large randomised study directly comparing the two methods, but that does not justify defenestrating the significant body of evidence demonstrating equivalence of success rates. This is not to mention the significant benefits that mild IVF brings in relation to health outcomes for women and children, and reduction in the burden of both treatment and the total cost.
The number of eggs collected per cycle in the UK is increasing annually with the risk of OHSS contained by the use of agonist trigger and 'freeze-all embryos' in the case of high oestradiol levels. While this strategy is an important emergency tool in reducing OHSS complications, it is not prevention and it should not be taken as a licence to ignore the dangers of ovarian stimulation, nor subjecting women to the concomitant side effects. True prevention is not placing women at OHSS risk in the first place by avoiding aggressive protocols of ovarian stimulation.
It must always be remembered that the protection of the welfare of women in IVF is a wider concept beyond OHSS prevention. There are additional treatments, such as the administration of intravenous immunology drugs, which may have potentially harmful effects and are in desperate need of more oversight. At present, lack of data collection and database linkage restrictions are obscuring our ability to determine the size of problem.
Instead of large-scale, rigorous analysis, we are often given bland reassurances that all is well with the state of IVF in the UK. Sensible proposals to protect the welfare of women are currently being put forward in Parliament by McDonagh and should be supported whatever one's view on the best stimulation strategy.
We surely all agree that the aim of IVF treatment should be to achieve a singleton, healthy, full term, normal weight baby, without putting a woman's health at risk in the short or long term. With the additional oversight and data, we will be able to speak confidently as one voice that we are protecting the welfare of women during IVF treatment.
#75
General Discussion / Chatbots will make genetic cou...
Last post by mensfe_admin - 2018-10-23 09:25Bring on the bots: 22 October 2018 - by Tara Schmidlen and Amy Curry Sturm
It's 2018, and Alexa has become a common household name. The iPhone has turned 10 and roughly two-thirds of adults worldwide own a smartphone. About 84 percent of the global population lives in an area where mobile broadband access is available. At the same time, genetic testing has become more affordable and accessible to consumers, with direct-to-consumer genetic testing pioneer, 23andMe, now boasting five million users in over 50 countries.
As the interest in and demand for genetic testing has increased, the demand for genetic counsellors – experts trained to help patients understand and make use of genetic information – is increasing. There are currently over 4800 certified genetic counsellors in North America. Clear Genetics, a healthcare technology company based in San Francisco, has collaborated with genetic counsellors working in a variety of patient-care settings to develop a chatbot named GIA (Genetic Information Assistant). GIA is a clinical-grade chatbot who assists patients pursuing genetic counselling, risk assessment and testing.
For those of you wondering what a bot, or chatbot, is – these are software-based simulated conversation tools. Chatbots use artificial intelligence and natural language processing to answer simple questions, increase and maintain consumer engagement, promote services, and provide convenient, easy access between consumers and service providers. Bots often handle repetitive questions from users, such as, 'Is my flight on time?' In the field of genetics, they can respond to questions like, 'Should my children also be tested?'
One American health entity using chatbot technology is Geisinger, a non-profit integrated health system serving over three million residents in Pennsylvania and southern New Jersey. Geisinger and Clear Genetics have collaborated to develop chatbots for communication with patients enrolled in the MyCode Community Health Initiative. MyCode is a large research biobank returning genetic test results for genes known to be associated with an increased risk for treatable and preventable heritable heart diseases and cancers.
Over 210,000 Geisinger patients are enrolled in MyCode, with at least 2 percent expected to have a disease-causing genetic variant for which there are potential treatment options. With so many patients enrolled, automation of some repetitive, scriptable communications would free up staff members and genetic counsellors for tasks that require human interaction.
To recruit patients into the MyCode study, Geisinger and Clear Genetics developed a consent chatbot that walks patients through components of the consent form, allowing them to opt to receive more or less detail on key topics (goals, benefits, risks, and so on). The tool is compliant with the Health Insurance Portability and Accountability Act 1996, and can be used on any mobile device. It is designed to record the decision (consent, considering, decline) in the patient's electronic health record. Geisinger patients who tested the consent chatbot in focus groups reacted positively, favoring the more informative and customisable chatbot experience to an in-person approach.
In addition to the consent chatbot, a patient 'follow-up' chatbot was developed to remind MyCode participants of suggested actions after they got their results. Via the follow-up chatbot, MyCode participants could indicate whether they had received a result packet, gathered their family history data, met with a provider to review results, and shared results with relatives. Patients could also request a genetic counselling visit and type in questions.
To help patients communicate their genetic test results with at-risk family members, a family sharing tool was developed as an easy mechanism to electronically share results and inform family members of the importance of genetic counselling and testing. The tool allows the patient to send their relatives a link to a 'cascade' genetic counselling chatbot by text message, email or Facebook messenger. The cascade chatbot describes the patient's result, associated disease risks and recommended management.
The patient's at-risk relative can request a genetic counselling visit via the chatbot and ask questions. Geisinger patients who have interacted with the family sharing tool and cascade chatbot report that they have enjoyed the ability to preview what their relative will see and welcome a tool that 'has the detailed information' and 'answers that wouldn't be on the tip of the tongue' when talking with family members about genetic test results.
Beyond the consent, follow up and cascade use cases described here, a chatbot like Clear Genetics' GIA, can free up genetic counsellors by automating many other routine tasks, such as delivering negative results and providing standard pre-test education.
Sceptics may lament that 'the bots are taking over'. But the goal is not to replace genetic counsellors with chatbots. Rather, the goal is to delegate important tasks that are repetitive, time-consuming and scriptable to a chatbot, like GIA, to leave genetic counsellors more time for more valuable and highly skilled patient care. More counsellor time will lead to greater accessibility of genetic counselling services. To that we enthusiastically say, bring on the bots.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
It's 2018, and Alexa has become a common household name. The iPhone has turned 10 and roughly two-thirds of adults worldwide own a smartphone. About 84 percent of the global population lives in an area where mobile broadband access is available. At the same time, genetic testing has become more affordable and accessible to consumers, with direct-to-consumer genetic testing pioneer, 23andMe, now boasting five million users in over 50 countries.
As the interest in and demand for genetic testing has increased, the demand for genetic counsellors – experts trained to help patients understand and make use of genetic information – is increasing. There are currently over 4800 certified genetic counsellors in North America. Clear Genetics, a healthcare technology company based in San Francisco, has collaborated with genetic counsellors working in a variety of patient-care settings to develop a chatbot named GIA (Genetic Information Assistant). GIA is a clinical-grade chatbot who assists patients pursuing genetic counselling, risk assessment and testing.
For those of you wondering what a bot, or chatbot, is – these are software-based simulated conversation tools. Chatbots use artificial intelligence and natural language processing to answer simple questions, increase and maintain consumer engagement, promote services, and provide convenient, easy access between consumers and service providers. Bots often handle repetitive questions from users, such as, 'Is my flight on time?' In the field of genetics, they can respond to questions like, 'Should my children also be tested?'
One American health entity using chatbot technology is Geisinger, a non-profit integrated health system serving over three million residents in Pennsylvania and southern New Jersey. Geisinger and Clear Genetics have collaborated to develop chatbots for communication with patients enrolled in the MyCode Community Health Initiative. MyCode is a large research biobank returning genetic test results for genes known to be associated with an increased risk for treatable and preventable heritable heart diseases and cancers.
Over 210,000 Geisinger patients are enrolled in MyCode, with at least 2 percent expected to have a disease-causing genetic variant for which there are potential treatment options. With so many patients enrolled, automation of some repetitive, scriptable communications would free up staff members and genetic counsellors for tasks that require human interaction.
To recruit patients into the MyCode study, Geisinger and Clear Genetics developed a consent chatbot that walks patients through components of the consent form, allowing them to opt to receive more or less detail on key topics (goals, benefits, risks, and so on). The tool is compliant with the Health Insurance Portability and Accountability Act 1996, and can be used on any mobile device. It is designed to record the decision (consent, considering, decline) in the patient's electronic health record. Geisinger patients who tested the consent chatbot in focus groups reacted positively, favoring the more informative and customisable chatbot experience to an in-person approach.
In addition to the consent chatbot, a patient 'follow-up' chatbot was developed to remind MyCode participants of suggested actions after they got their results. Via the follow-up chatbot, MyCode participants could indicate whether they had received a result packet, gathered their family history data, met with a provider to review results, and shared results with relatives. Patients could also request a genetic counselling visit and type in questions.
To help patients communicate their genetic test results with at-risk family members, a family sharing tool was developed as an easy mechanism to electronically share results and inform family members of the importance of genetic counselling and testing. The tool allows the patient to send their relatives a link to a 'cascade' genetic counselling chatbot by text message, email or Facebook messenger. The cascade chatbot describes the patient's result, associated disease risks and recommended management.
The patient's at-risk relative can request a genetic counselling visit via the chatbot and ask questions. Geisinger patients who have interacted with the family sharing tool and cascade chatbot report that they have enjoyed the ability to preview what their relative will see and welcome a tool that 'has the detailed information' and 'answers that wouldn't be on the tip of the tongue' when talking with family members about genetic test results.
Beyond the consent, follow up and cascade use cases described here, a chatbot like Clear Genetics' GIA, can free up genetic counsellors by automating many other routine tasks, such as delivering negative results and providing standard pre-test education.
Sceptics may lament that 'the bots are taking over'. But the goal is not to replace genetic counsellors with chatbots. Rather, the goal is to delegate important tasks that are repetitive, time-consuming and scriptable to a chatbot, like GIA, to leave genetic counsellors more time for more valuable and highly skilled patient care. More counsellor time will lead to greater accessibility of genetic counselling services. To that we enthusiastically say, bring on the bots.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
#76
Research / Home DNA test kits should come...
Last post by mensfe_admin - 2018-10-22 14:1024 September 2018 - by Rachel Siden
The UK's Human Fertilisation and Embryology Authority (HFEA) is urging companies that offer direct-to-consumer DNA testing to provide more comprehensive warnings to customers.
A recent paper presented to the HFEA board, oulined how egg and sperm donors, as well as donor-conceived people, could be impacted by direct-to-consumer DNA testing and 'matching' services which offer to connect customers who are genetically related to each other. DNA testing services could reveal someone's unknown donor-conceived status, or uncover the identity of a donor who believed they had anonymity.
'Donors who think the anonymity can be protected are suddenly discovering they can't,' said Nina Barnsley, director of the Donor Conception Network. 'Even if you don't upload your DNA anywhere, you can still be found. It's a new world and we are all playing catch-up,' she told The Guardian newspaper.
While popular DNA testing companies such as 23andMe, Ancestry.com, and DNA.com can only 'match' users within their databases, customers could still use a single match to track down other relatives through social media or birth and marriage records. And while these companies may disclose that unexpected genetic information may be discovered 'in the small print', the HFEA paper argues that customers may not be adequately warned of the risks, nor offered any support.
'We found no DNA testing and matching services that mention that a need for professional emotional support may arise from relatedness matching, or via further inference from matching,' stated the HFEA paper. 'No service offers professional emotional support to users, nor signposts to other available support.'
While the HFEA does not have the authority to force companies to provide warnings, the HFEA paper outlines a response plan that includes raising awareness of these risks and providing information and support through the HFEA website and clinics, and reaching out to DNA testing companies to have a dialogue about why greater warning should be provided on their websites.
HFEA Chair Sally Cheshire has pledged that the websites will be contacted and that these issues will be discussed with the UK's Department of Health, The Guardian reported.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
Prenatal tests are misused for sex-selection in the UK
24 September 2018 - by Rikita Patel
Prenatal tests offered by private UK clinics are misused for sex-selection and could lead to abortions of female fetuses, according to a BBC investigation.
Non-invasive prenatal testing (NIPT) involves screening fetal DNA in the mother's blood to identify genetic abnormalities, such as Down's syndrome. The technique also enables mothers to find out their baby's sex as early as nine to 10 weeks into pregnancy. However, when the test is implemented within the NHS next month, patients will not be provided with this information.
In contrast, private clinics are revealing gender information from NIPT to expectant mothers. An investigation by BBC Two's Victoria Derbyshire programme has found that thousands of pregnant women are using online forums to discuss sex-selection through NIPT and their concerns about having a baby girl. Further, it found that clinics in Slough, Berkshire, were openly advertising gender determination testing.
Due to concerns that pregnancies could be aborted based on preference for a male child, the Labour Party has called for a ban on parents being told the sex of their baby.
Naz Shah, Labour MP for Bradford and shadow minister for women and equalities, told the programme that 'cultural practices in some communities, like the South Asian community, have a preference for boys' which is 'forcing them to adopt methods such as NIPT to live up to expectations of family members'.
In UK law, the sex of the baby is not one of the permitted grounds for abortion. However, if a woman is likely to face violence or abuse as a result of giving birth to a baby girl, a termination in the first 24 weeks could be lawful, as the Abortion Act states, if 'continuance of the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman'. The act allows that 'account may be taken of the pregnant woman's actual or reasonably foreseeable environment'.
Speaking to the BBC, Tom Shakespeare, professor of disability research at Norwich Medical School and chair of the Nuffield Council on Bioethics' NIPT working group, said: 'The desire for sex-selection is a major driver of private-sector testing.
'But countries like China and India have recognised the problem of sex-selective abortion and so it's very difficult to get this information – in India it is illegal.'
If the UK permits the practice of releasing this information, nationals from those countries may travel to the UK for medical tourism, Professor Shakespeare said.
A Department of Health and Social Care spokesman told the BBC: 'The prenatal test is never meant to be used for determining the sex of a child. We will continue to review the evidence.'
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
The UK's Human Fertilisation and Embryology Authority (HFEA) is urging companies that offer direct-to-consumer DNA testing to provide more comprehensive warnings to customers.
A recent paper presented to the HFEA board, oulined how egg and sperm donors, as well as donor-conceived people, could be impacted by direct-to-consumer DNA testing and 'matching' services which offer to connect customers who are genetically related to each other. DNA testing services could reveal someone's unknown donor-conceived status, or uncover the identity of a donor who believed they had anonymity.
'Donors who think the anonymity can be protected are suddenly discovering they can't,' said Nina Barnsley, director of the Donor Conception Network. 'Even if you don't upload your DNA anywhere, you can still be found. It's a new world and we are all playing catch-up,' she told The Guardian newspaper.
While popular DNA testing companies such as 23andMe, Ancestry.com, and DNA.com can only 'match' users within their databases, customers could still use a single match to track down other relatives through social media or birth and marriage records. And while these companies may disclose that unexpected genetic information may be discovered 'in the small print', the HFEA paper argues that customers may not be adequately warned of the risks, nor offered any support.
'We found no DNA testing and matching services that mention that a need for professional emotional support may arise from relatedness matching, or via further inference from matching,' stated the HFEA paper. 'No service offers professional emotional support to users, nor signposts to other available support.'
While the HFEA does not have the authority to force companies to provide warnings, the HFEA paper outlines a response plan that includes raising awareness of these risks and providing information and support through the HFEA website and clinics, and reaching out to DNA testing companies to have a dialogue about why greater warning should be provided on their websites.
HFEA Chair Sally Cheshire has pledged that the websites will be contacted and that these issues will be discussed with the UK's Department of Health, The Guardian reported.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
Prenatal tests are misused for sex-selection in the UK
24 September 2018 - by Rikita Patel
Prenatal tests offered by private UK clinics are misused for sex-selection and could lead to abortions of female fetuses, according to a BBC investigation.
Non-invasive prenatal testing (NIPT) involves screening fetal DNA in the mother's blood to identify genetic abnormalities, such as Down's syndrome. The technique also enables mothers to find out their baby's sex as early as nine to 10 weeks into pregnancy. However, when the test is implemented within the NHS next month, patients will not be provided with this information.
In contrast, private clinics are revealing gender information from NIPT to expectant mothers. An investigation by BBC Two's Victoria Derbyshire programme has found that thousands of pregnant women are using online forums to discuss sex-selection through NIPT and their concerns about having a baby girl. Further, it found that clinics in Slough, Berkshire, were openly advertising gender determination testing.
Due to concerns that pregnancies could be aborted based on preference for a male child, the Labour Party has called for a ban on parents being told the sex of their baby.
Naz Shah, Labour MP for Bradford and shadow minister for women and equalities, told the programme that 'cultural practices in some communities, like the South Asian community, have a preference for boys' which is 'forcing them to adopt methods such as NIPT to live up to expectations of family members'.
In UK law, the sex of the baby is not one of the permitted grounds for abortion. However, if a woman is likely to face violence or abuse as a result of giving birth to a baby girl, a termination in the first 24 weeks could be lawful, as the Abortion Act states, if 'continuance of the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman'. The act allows that 'account may be taken of the pregnant woman's actual or reasonably foreseeable environment'.
Speaking to the BBC, Tom Shakespeare, professor of disability research at Norwich Medical School and chair of the Nuffield Council on Bioethics' NIPT working group, said: 'The desire for sex-selection is a major driver of private-sector testing.
'But countries like China and India have recognised the problem of sex-selective abortion and so it's very difficult to get this information – in India it is illegal.'
If the UK permits the practice of releasing this information, nationals from those countries may travel to the UK for medical tourism, Professor Shakespeare said.
A Department of Health and Social Care spokesman told the BBC: 'The prenatal test is never meant to be used for determining the sex of a child. We will continue to review the evidence.'
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
#77
General Discussion / FREQUENT SEX IMPROVES SPERM
Last post by mensfe_admin - 2018-10-22 14:08Frequent sex – not abstinence – is better for sperm quality
24 September 2018 - by Christie Whitehouse
Sperm quality and pregnancy outcomes in IVF may be improved with frequent ejaculation, a new study suggests.
Research carried out at the Centre for Reproductive Medicine in Shenyang, China, aimed to determine the effects of a short period of abstinence on the quality of ejaculated sperm, as well as its effect on the pregnancy outcomes of 500 couples undergoing IVF. Major molecular differences were seen between samples of semen depending on the duration of abstinence.
Specifically, semen samples collected after only one to three hours of abstinence contained more motile sperm with a higher reproductive potential than samples collected after men had abstained for three to seven days.
'For years, men have usually been advised to limit sexual activity to increase the chances of pregnancy. However, it's time to change our minds,' said Dr Da Li, who led the study along with Dr XiuXia Wang.
'Our data indicates couples with relatively normal semen parameters should have frequent sex around the ovulation period. This could make all the difference to their efforts to start a family.'
Mass spectrometry used to analyse the protein content of semen showed that proteins involved in cell adhesion (important for fusing with the egg), motility and metabolism were increased when men abstained for only a few hours compared with days. The total antioxidant capacity of sperm was also significantly improved after reduced abstinence, leading to reduced genetic damage by oxidative stress and increasing the chance of viable proteins being formed.
Encouraging results were also seen in the couples undergoing IVF treatment. Typically, the live birth rate in a cohort of this size would be around 30 percent, said Dr Li. However, live births in the group using semen provided only a few hours after previous ejaculation were increased by one third compared with the group using semen ejaculated after a longer period of abstinence.
These results collectively suggest that having more frequent sex produces sperm of a better quality and increases the likelihood of a successful pregnancy.
The researchers now plan to carry out further research into the protein composition of semen, specifically looking at the post-translational modifications of the different samples. The Centre for Reproductive Medicine is also updating its IVF protocols to use semen from shorter periods of abstinence.
The study was published in Molecular and Cellular Proteomics.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
24 September 2018 - by Christie Whitehouse
Sperm quality and pregnancy outcomes in IVF may be improved with frequent ejaculation, a new study suggests.
Research carried out at the Centre for Reproductive Medicine in Shenyang, China, aimed to determine the effects of a short period of abstinence on the quality of ejaculated sperm, as well as its effect on the pregnancy outcomes of 500 couples undergoing IVF. Major molecular differences were seen between samples of semen depending on the duration of abstinence.
Specifically, semen samples collected after only one to three hours of abstinence contained more motile sperm with a higher reproductive potential than samples collected after men had abstained for three to seven days.
'For years, men have usually been advised to limit sexual activity to increase the chances of pregnancy. However, it's time to change our minds,' said Dr Da Li, who led the study along with Dr XiuXia Wang.
'Our data indicates couples with relatively normal semen parameters should have frequent sex around the ovulation period. This could make all the difference to their efforts to start a family.'
Mass spectrometry used to analyse the protein content of semen showed that proteins involved in cell adhesion (important for fusing with the egg), motility and metabolism were increased when men abstained for only a few hours compared with days. The total antioxidant capacity of sperm was also significantly improved after reduced abstinence, leading to reduced genetic damage by oxidative stress and increasing the chance of viable proteins being formed.
Encouraging results were also seen in the couples undergoing IVF treatment. Typically, the live birth rate in a cohort of this size would be around 30 percent, said Dr Li. However, live births in the group using semen provided only a few hours after previous ejaculation were increased by one third compared with the group using semen ejaculated after a longer period of abstinence.
These results collectively suggest that having more frequent sex produces sperm of a better quality and increases the likelihood of a successful pregnancy.
The researchers now plan to carry out further research into the protein composition of semen, specifically looking at the post-translational modifications of the different samples. The Centre for Reproductive Medicine is also updating its IVF protocols to use semen from shorter periods of abstinence.
The study was published in Molecular and Cellular Proteomics.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
#78
General Discussion / SPERM - MAIL ON SUNDAY ?? It's...
Last post by mensfe_admin - 2018-10-22 14:0724 September 2018 - by Dr Anna Smajdor
In the wake of a recent Mail on Sunday article, one might wonder if there are grounds for moving from a small-scale subsistence-type approach to the harvest, to a more industrial approach. No, we are not talking about vegetables here, but... sperm.
Yet again, a case has emerged in which a man's sperm has been 'harvested' without his consent. The incident in question happened in the UK in 2014, according to the Mail on Sunday. The newspaper reported that a UK couple had had sperm taken from their son who had died in a motorbike accident, frozen it and a year later shipped it to a fertility clinic in the USA, where sex selection was used to produce a male grandchild (see BioNews 967).
The article itself is peculiar in several ways, not least in the fact that it claims that the 2014 case 'may be the first instance of posthumous sperm extraction'. Yet some paragraphs later, it details the case of Diane Blood, who famously fought the law and won, on the issue of whether sperm harvested from her dead husband Stephen could be used to enable her to conceive. (Sperm was 'harvested' from Stephen Blood both while he was dying, and after he was dead.)
So the case described by the Mail on Sunday reporter is not unique. In fact, it resembles many other such incidents that have emerged since Diane Blood's pioneering battle. There has been a succession of dead or dying men, whose bodies have been 'harvested' without their consent in order for others to make use of the seeds thus obtained.
I do not propose to give copious details of each separate occurrence here: they are very similar. In each case a man unexpectedly falls critically ill. One or more loved ones – spouses/parents, request sperm-harvesting, which is duly carried out by doctors in contravention of UK law. This case may look different in some respects: the dead man's parents wanted to choose the sex of their grandchild, which would also be illegal in the UK, but is permitted in many other jurisdictions. However, as long as it remains the case that sperm can be exported for use abroad, it is not surprising that people should seek to use it in ways that are legally acceptable in those countries. The key issue I want to focus on here is the common feature in all these cases: the harvesting of sperm without consent. What happens afterwards is a secondary issue.
Does consent matter? After Stephen Blood's sperm was harvested, many people thought it did matter. The case was described as 'unique' and something that could never happen again. Part of the reason for this is not just the significance that people attach to sperm, but because of the importance that English law places on a person's right to determine what happens to their body. Not just while they are alive, but throughout the period during which they are dying and even after they are dead.
There are two methods for 'harvesting' sperm. Both are highly invasive. The method used in Stephen Blood's case was electro-ejaculation. An electric probe is inserted into the dead or dying man's rectum. A current is applied in rhythmic waves at increasing voltage until ejaculation occurs, usually into the bladder. A catheter is inserted through the urethra into the bladder to retrieve the sperm. This method is more common among patients who are brain dead but whose respiratory and circulatory functions are being sustained.
The other method is more common in use among men who are not being ventilated. It involves cutting into the testicles. The technique is described in one paper as follows: '... surgical bilateral resection in bloc of the proximal part of vas deferens, testicle and epididymis. At the laboratory, by milking the epididymis and vas deferens, the extracted fluid was collected...'.
Of course many men might view these procedures as being an acceptable means of allowing their loved one(s) to create children. But equally, many might not. In the context of organ donation, we expect that people will make judgments about what happens to their body – and that these judgments should be respected as far as possible.
When we are faced with reproductive material, a different standard seems to apply. The issue is complicated because – as I have argued elsewhere – the person whose testimony is given as to the dead or dying man's probable willingness to undergo sperm harvesting is usually the very person whose interests are most entangled with the outcome.
To put this another way, the parents or spouses who want to harvest their loved one's sperm are asked whether this is what the dead man would have wanted. Of course their perception is coloured by their own desire. They stand to benefit from the procedure. Thus, while consent from loved ones is sometimes used as a proxy for organ donation, it does not follow that the same standard should apply to reproductive tissue harvesting when the prospective beneficiary is also the one giving proxy consent. This is straightforwardly a conflict of interest and should be recognised as such.
So why does this continue to happen? The Human Fertilisation and Embryology Act was drawn up so as to focus on the acceptability of storing sperm and using it in treatment. Both require the consent of the person from whom it was obtained. Yet the 'harvesting' itself is not explicitly included in the Act.
Of course that does not mean that gamete harvesting is simply unregulated. Rather, it is assumed to fall under the more general law that protects people from undergoing unwarranted medical procedures or physical assault. But this law is clearly not functioning as it should do to prevent the harvesting of reproductive tissue from dead and dying people.
Diane Blood's legal victory has paved the way for subsequent infringements of men's bodily integrity. Because, despite the fact that her husband's sperm was harvested without his consent, she was permitted to take it abroad and use it for treatment. It is clear that other people quite reasonably expect to do the same thing. Until the law is tightened up and/or prosecutions are brought for gamete harvesting without consent, the bodies of dead and dying men are vulnerable to exploitation.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
In the wake of a recent Mail on Sunday article, one might wonder if there are grounds for moving from a small-scale subsistence-type approach to the harvest, to a more industrial approach. No, we are not talking about vegetables here, but... sperm.
Yet again, a case has emerged in which a man's sperm has been 'harvested' without his consent. The incident in question happened in the UK in 2014, according to the Mail on Sunday. The newspaper reported that a UK couple had had sperm taken from their son who had died in a motorbike accident, frozen it and a year later shipped it to a fertility clinic in the USA, where sex selection was used to produce a male grandchild (see BioNews 967).
The article itself is peculiar in several ways, not least in the fact that it claims that the 2014 case 'may be the first instance of posthumous sperm extraction'. Yet some paragraphs later, it details the case of Diane Blood, who famously fought the law and won, on the issue of whether sperm harvested from her dead husband Stephen could be used to enable her to conceive. (Sperm was 'harvested' from Stephen Blood both while he was dying, and after he was dead.)
So the case described by the Mail on Sunday reporter is not unique. In fact, it resembles many other such incidents that have emerged since Diane Blood's pioneering battle. There has been a succession of dead or dying men, whose bodies have been 'harvested' without their consent in order for others to make use of the seeds thus obtained.
I do not propose to give copious details of each separate occurrence here: they are very similar. In each case a man unexpectedly falls critically ill. One or more loved ones – spouses/parents, request sperm-harvesting, which is duly carried out by doctors in contravention of UK law. This case may look different in some respects: the dead man's parents wanted to choose the sex of their grandchild, which would also be illegal in the UK, but is permitted in many other jurisdictions. However, as long as it remains the case that sperm can be exported for use abroad, it is not surprising that people should seek to use it in ways that are legally acceptable in those countries. The key issue I want to focus on here is the common feature in all these cases: the harvesting of sperm without consent. What happens afterwards is a secondary issue.
Does consent matter? After Stephen Blood's sperm was harvested, many people thought it did matter. The case was described as 'unique' and something that could never happen again. Part of the reason for this is not just the significance that people attach to sperm, but because of the importance that English law places on a person's right to determine what happens to their body. Not just while they are alive, but throughout the period during which they are dying and even after they are dead.
There are two methods for 'harvesting' sperm. Both are highly invasive. The method used in Stephen Blood's case was electro-ejaculation. An electric probe is inserted into the dead or dying man's rectum. A current is applied in rhythmic waves at increasing voltage until ejaculation occurs, usually into the bladder. A catheter is inserted through the urethra into the bladder to retrieve the sperm. This method is more common among patients who are brain dead but whose respiratory and circulatory functions are being sustained.
The other method is more common in use among men who are not being ventilated. It involves cutting into the testicles. The technique is described in one paper as follows: '... surgical bilateral resection in bloc of the proximal part of vas deferens, testicle and epididymis. At the laboratory, by milking the epididymis and vas deferens, the extracted fluid was collected...'.
Of course many men might view these procedures as being an acceptable means of allowing their loved one(s) to create children. But equally, many might not. In the context of organ donation, we expect that people will make judgments about what happens to their body – and that these judgments should be respected as far as possible.
When we are faced with reproductive material, a different standard seems to apply. The issue is complicated because – as I have argued elsewhere – the person whose testimony is given as to the dead or dying man's probable willingness to undergo sperm harvesting is usually the very person whose interests are most entangled with the outcome.
To put this another way, the parents or spouses who want to harvest their loved one's sperm are asked whether this is what the dead man would have wanted. Of course their perception is coloured by their own desire. They stand to benefit from the procedure. Thus, while consent from loved ones is sometimes used as a proxy for organ donation, it does not follow that the same standard should apply to reproductive tissue harvesting when the prospective beneficiary is also the one giving proxy consent. This is straightforwardly a conflict of interest and should be recognised as such.
So why does this continue to happen? The Human Fertilisation and Embryology Act was drawn up so as to focus on the acceptability of storing sperm and using it in treatment. Both require the consent of the person from whom it was obtained. Yet the 'harvesting' itself is not explicitly included in the Act.
Of course that does not mean that gamete harvesting is simply unregulated. Rather, it is assumed to fall under the more general law that protects people from undergoing unwarranted medical procedures or physical assault. But this law is clearly not functioning as it should do to prevent the harvesting of reproductive tissue from dead and dying people.
Diane Blood's legal victory has paved the way for subsequent infringements of men's bodily integrity. Because, despite the fact that her husband's sperm was harvested without his consent, she was permitted to take it abroad and use it for treatment. It is clear that other people quite reasonably expect to do the same thing. Until the law is tightened up and/or prosecutions are brought for gamete harvesting without consent, the bodies of dead and dying men are vulnerable to exploitation.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
#79
Research / Molecular signature' of childh...
Last post by mensfe_admin - 2018-10-22 14:008 October 2018 - by Bethany Muller
Scientists have discovered alterations in the sperm cell DNA of adult men who had been abused as children.
Men who had experienced childhood abuse carried epigenetic markers – which alter gene expression – that appeared to be linked to their early-life trauma.
'We can look at our study as one small piece in the huge overall puzzle of how intergeneration trauma works,' said study author Nicole Gladish, a PhD candidate at the University of British Columbia in Canada. 'It is certainly possible that epigenetic changes in sperm cells play a role in the physical and mental health of the next generation, but we don't know for sure.'
The study, carried out at the University of British Columbia and Harvard University in Cambridge, Massachusetts, looked at methylation patterns in sperm from 34 men, who were classed as having been exposed to childhood abuse or not.
Differences in DNA methylation between the two groups were found in 12 regions of the genome. These regions play roles in the brain, regulation of body weight and the immune system.
DNA methylation is a common type of epigenetic tag. Epigenetics alter the packaging of nuclear information, altering the way genes are accessed and expressed. Methylation in particular is often described as having a 'dimming' effect, leading to the down-regulation of genes.
'When the sperm meets the egg, there is a massive amount of genetic reshuffling, and most of the methylation is at least temporarily erased,' Dr Andrea Roberts, lead author of the publication, noted. 'But finding a molecular signature in sperm brings us at least a step closer to determining whether child abuse might affect the health of the victim's offspring.'
The researchers also suggest that DNA methylation in sperm has the potential to be used as a biomarker as evidence of whether abuse had happened in a criminal justice case. Professor Michael Kobor, a medical geneticist at the University of British Columbia, and also a study author said: 'It's conceivable that the correlations we found between methylation and child abuse might provide a percentage probability that abuse had occurred.'
Environment-induced epigenetic changes have been shown to be passed on to offspring in animals. However, the impact of psychosocial stress on human sperm and eggs is not well understood.
Next the researchers plan to investigate whether these epigenetic changes would persist in the children of men who had experienced abuse. Larger-scale studies could help to find out whether the effect of childhood abuse could be passed on further down the generations.
The research was published in Translational Psychiatry.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
Scientists have discovered alterations in the sperm cell DNA of adult men who had been abused as children.
Men who had experienced childhood abuse carried epigenetic markers – which alter gene expression – that appeared to be linked to their early-life trauma.
'We can look at our study as one small piece in the huge overall puzzle of how intergeneration trauma works,' said study author Nicole Gladish, a PhD candidate at the University of British Columbia in Canada. 'It is certainly possible that epigenetic changes in sperm cells play a role in the physical and mental health of the next generation, but we don't know for sure.'
The study, carried out at the University of British Columbia and Harvard University in Cambridge, Massachusetts, looked at methylation patterns in sperm from 34 men, who were classed as having been exposed to childhood abuse or not.
Differences in DNA methylation between the two groups were found in 12 regions of the genome. These regions play roles in the brain, regulation of body weight and the immune system.
DNA methylation is a common type of epigenetic tag. Epigenetics alter the packaging of nuclear information, altering the way genes are accessed and expressed. Methylation in particular is often described as having a 'dimming' effect, leading to the down-regulation of genes.
'When the sperm meets the egg, there is a massive amount of genetic reshuffling, and most of the methylation is at least temporarily erased,' Dr Andrea Roberts, lead author of the publication, noted. 'But finding a molecular signature in sperm brings us at least a step closer to determining whether child abuse might affect the health of the victim's offspring.'
The researchers also suggest that DNA methylation in sperm has the potential to be used as a biomarker as evidence of whether abuse had happened in a criminal justice case. Professor Michael Kobor, a medical geneticist at the University of British Columbia, and also a study author said: 'It's conceivable that the correlations we found between methylation and child abuse might provide a percentage probability that abuse had occurred.'
Environment-induced epigenetic changes have been shown to be passed on to offspring in animals. However, the impact of psychosocial stress on human sperm and eggs is not well understood.
Next the researchers plan to investigate whether these epigenetic changes would persist in the children of men who had experienced abuse. Larger-scale studies could help to find out whether the effect of childhood abuse could be passed on further down the generations.
The research was published in Translational Psychiatry.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
#80
Research / MEN ARE NOT GETTING ADEQUATE C...
Last post by mensfe_admin - 2018-10-22 13:57Men are not getting adequate care for infertility
8 October 2018 - by Professor Sheena Lewis
There has been much media interest in male infertility care this year, but two major issues have stood out. The first is the inadequacy of care for the man, from incomplete diagnosis to non-information about his treatment choices. The second is the use of a vulnerable woman to undergo invasive fertility treatment in order to treat a third party – her male partner. This is unparalleled in other branches of medicine.
There are clear reasons why this situation has come about. There are also clear motivations for why we must act to change it, both at an individual and a societal level. To understand more, let's explore some contributing factors.
Mind the gap
The advent of intracytoplasmic sperm injection (ICSI), where a sperm cell is injected directly into the egg cell, was a quantum leap in short-term clinical success. But it has led to a lethargy in progressing our evidence-based diagnosis of male infertility. We must make it a research priority to plug these knowledge gaps.
In their recent focused issue of Translational Andrology and Urology, Dr James Hotaling of the University of Utah and Dr Ranjith Ramasamy of the University of Miami suggest that 'we need to identify what issues need to be solved to bring male infertility care to the same level of diagnosis and treatment as female infertility'.
Inadequate diagnosis
Conventional semen analysis is routinely used in male fertility diagnoses. But it is widely reported that there is little association between semen parameters and male infertility diagnosis. It also has little relationship with IVF outcomes and no relationship with ICSI outcomes.
Further, around 30 percent of couples are given a diagnosis of unexplained infertility. These couples are often referred for ICSI, rather than using some of the tests shown to identify defects such as sperm DNA damage that are present in the majority of these men. If there is no diagnosis, there can be no direct solution. This leads to expensive, invasive, prolonged and often unsuccessful cycles of treatment. Since ICSI now accounts for a significant proportion of fertility treatments across Europe, we particularly need a test to predict which patients will benefit from it.
Inequality of care
Fertility treatment is primarily focused on women. This is to be expected since the speciality is run by gynaecologists and obstetricians whose training is in female, not male, reproduction. However, this can lead to men feeling ignored and emasculated by the whole fertility journey. There are even examples of doctors telling the female partners the devasting result of azoospermia, rather than telling her male partner to whom the results relate.
The woman is also affected by inequality of care. In up to 30 percent of ICSI cycles, the woman has no detectable reproductive anomalies, yet she undergoes this invasive form of treatment to treat a dysfunction in her partner. She consents to this procedure willingly as usually she is told there is no other way to conceive the child they yearn for.
Inadequate treatment options
In all branches of medicine except reproductive technology, interventions are to treat the patient's symptoms. In our speciality, ICSI is used to bypass the problem of male symptoms. Since treatment is unsuccessful for so many couples, would it not seem prudent to suggest interventions to improve the quality of sperm before treatment?
There are simple ways to do this. Doctors must take a detailed clinical history of the patient, examine him and know which medications he is taking. He may be on drugs as seemingly innocuous as drug treatments for hair loss, which can lower his sperm count. His semen also needs more than the 'first step' semen analysis. Semen should be cultured to detect infections that can be treated with antibiotics. Specialised tests for oxidative stress and sperm DNA quality should be done to find out if he needs antioxidant supplementation. Using supplements as a panacea without a clinical indication can damage his health and his sperm.
Since men have a turnover in sperm every few months, lifestyle changes can bring about rapid improvements. Simple changes in diet, weight loss and reduction or cessation of smoking, anabolic steroid use and recreational drug use can improve sperm health. These low-cost and effective interventions are too often ignored.
Static success rates
IVF success rates have remained at their modest level of less than 30 percent live birth rate for many years now. Improvements have been among the couples who can be treated for an underlying condition. For example, we can now treat men with obstructive azoospermia with testicular sperm. Single women can use donor sperm and gay couples can use surrogacy. But the actual IVF success rate per couple has remained disappointingly low.
Given that the numbers of couples seeking fertility investigations are increasing by eight to nine percent a year across Europe, it is imperative that success rates are improved. How is this most likely to occur? I would suggest it will be through advancements in male investigations leading to more accurate male diagnosis, complemented by therapy pre-ART.
Impact on offspring
We have, as yet, little evidence of the health of people conceived by ICSI as they reach middle-age. However, we already know that young men conceived by ICSI inherit poor semen quality and possibly infertility from their fathers. A recent small study suggested that IVF children have a six times higher risk of hypertension than children conceived naturally (see BioNews 966).
Using aging and smoking as paradigms for poor sperm quality, there are reports – such as one I authored – that ART is linked to increases in childhood cancers and psychiatric disease in offspring. Does this not create a further moral imperative to improve sperm quality as much as possible before ART?
An indicator of male health
Poor semen quality, as assessed by semen analysis, has been highlighted as a significant predictor for cardiovascular risk, late-onset cancers and shortened life expectancy. This may lead to its use as an inexpensive, non-invasive biomarker of late-onset disease. If we had a better test for sperm quality, this could prove useful in this application too.
One mechanism for change
So, what can we do about these shortcomings in our speciality? Perhaps we can follow the Australian example of forming a national 'centre without walls' funded by government to raise awareness of male reproductive health disorders and their associations with chronic disease. Andrology Australia provides a range of activities to educate men and improve their reproductive health of males through community and professional education. Perhaps it's time that we in the UK followed suit.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.
8 October 2018 - by Professor Sheena Lewis
There has been much media interest in male infertility care this year, but two major issues have stood out. The first is the inadequacy of care for the man, from incomplete diagnosis to non-information about his treatment choices. The second is the use of a vulnerable woman to undergo invasive fertility treatment in order to treat a third party – her male partner. This is unparalleled in other branches of medicine.
There are clear reasons why this situation has come about. There are also clear motivations for why we must act to change it, both at an individual and a societal level. To understand more, let's explore some contributing factors.
Mind the gap
The advent of intracytoplasmic sperm injection (ICSI), where a sperm cell is injected directly into the egg cell, was a quantum leap in short-term clinical success. But it has led to a lethargy in progressing our evidence-based diagnosis of male infertility. We must make it a research priority to plug these knowledge gaps.
In their recent focused issue of Translational Andrology and Urology, Dr James Hotaling of the University of Utah and Dr Ranjith Ramasamy of the University of Miami suggest that 'we need to identify what issues need to be solved to bring male infertility care to the same level of diagnosis and treatment as female infertility'.
Inadequate diagnosis
Conventional semen analysis is routinely used in male fertility diagnoses. But it is widely reported that there is little association between semen parameters and male infertility diagnosis. It also has little relationship with IVF outcomes and no relationship with ICSI outcomes.
Further, around 30 percent of couples are given a diagnosis of unexplained infertility. These couples are often referred for ICSI, rather than using some of the tests shown to identify defects such as sperm DNA damage that are present in the majority of these men. If there is no diagnosis, there can be no direct solution. This leads to expensive, invasive, prolonged and often unsuccessful cycles of treatment. Since ICSI now accounts for a significant proportion of fertility treatments across Europe, we particularly need a test to predict which patients will benefit from it.
Inequality of care
Fertility treatment is primarily focused on women. This is to be expected since the speciality is run by gynaecologists and obstetricians whose training is in female, not male, reproduction. However, this can lead to men feeling ignored and emasculated by the whole fertility journey. There are even examples of doctors telling the female partners the devasting result of azoospermia, rather than telling her male partner to whom the results relate.
The woman is also affected by inequality of care. In up to 30 percent of ICSI cycles, the woman has no detectable reproductive anomalies, yet she undergoes this invasive form of treatment to treat a dysfunction in her partner. She consents to this procedure willingly as usually she is told there is no other way to conceive the child they yearn for.
Inadequate treatment options
In all branches of medicine except reproductive technology, interventions are to treat the patient's symptoms. In our speciality, ICSI is used to bypass the problem of male symptoms. Since treatment is unsuccessful for so many couples, would it not seem prudent to suggest interventions to improve the quality of sperm before treatment?
There are simple ways to do this. Doctors must take a detailed clinical history of the patient, examine him and know which medications he is taking. He may be on drugs as seemingly innocuous as drug treatments for hair loss, which can lower his sperm count. His semen also needs more than the 'first step' semen analysis. Semen should be cultured to detect infections that can be treated with antibiotics. Specialised tests for oxidative stress and sperm DNA quality should be done to find out if he needs antioxidant supplementation. Using supplements as a panacea without a clinical indication can damage his health and his sperm.
Since men have a turnover in sperm every few months, lifestyle changes can bring about rapid improvements. Simple changes in diet, weight loss and reduction or cessation of smoking, anabolic steroid use and recreational drug use can improve sperm health. These low-cost and effective interventions are too often ignored.
Static success rates
IVF success rates have remained at their modest level of less than 30 percent live birth rate for many years now. Improvements have been among the couples who can be treated for an underlying condition. For example, we can now treat men with obstructive azoospermia with testicular sperm. Single women can use donor sperm and gay couples can use surrogacy. But the actual IVF success rate per couple has remained disappointingly low.
Given that the numbers of couples seeking fertility investigations are increasing by eight to nine percent a year across Europe, it is imperative that success rates are improved. How is this most likely to occur? I would suggest it will be through advancements in male investigations leading to more accurate male diagnosis, complemented by therapy pre-ART.
Impact on offspring
We have, as yet, little evidence of the health of people conceived by ICSI as they reach middle-age. However, we already know that young men conceived by ICSI inherit poor semen quality and possibly infertility from their fathers. A recent small study suggested that IVF children have a six times higher risk of hypertension than children conceived naturally (see BioNews 966).
Using aging and smoking as paradigms for poor sperm quality, there are reports – such as one I authored – that ART is linked to increases in childhood cancers and psychiatric disease in offspring. Does this not create a further moral imperative to improve sperm quality as much as possible before ART?
An indicator of male health
Poor semen quality, as assessed by semen analysis, has been highlighted as a significant predictor for cardiovascular risk, late-onset cancers and shortened life expectancy. This may lead to its use as an inexpensive, non-invasive biomarker of late-onset disease. If we had a better test for sperm quality, this could prove useful in this application too.
One mechanism for change
So, what can we do about these shortcomings in our speciality? Perhaps we can follow the Australian example of forming a national 'centre without walls' funded by government to raise awareness of male reproductive health disorders and their associations with chronic disease. Andrology Australia provides a range of activities to educate men and improve their reproductive health of males through community and professional education. Perhaps it's time that we in the UK followed suit.
Click here to view SOURCES & REFERENCES and RELATED ARTICLES from the BIONEWS ARCHIVE or to leave a comment about this article.