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 11 
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Started by mensfe_admin - Last post by mensfe_admin
24 May 2021 - by Dr Emma Green
A new model able to predict cognitive decline in Alzheimer's disease could help to develop personalised treatments.

With an aim to identify therapeutic targets, researchers at McGill University, Canada, combined results from brain scans with gene activity data. This allowed them to explore the relationship between changes in gene expression and physical changes in the brain across normal brain ageing and cognitive decline associated with Alzheimer's disease.

'We wanted to combine whole-brain gene activity measurements with clinical scan data in a comprehensive and personalised model, which we then validated in healthy ageing and Alzheimer's disease' said lead author Quadri Adewale.

The study included brain scans from 460 people across a minimum of three time points with participants classed as a healthy control with no symptoms, with early mild cognitive impairment, late mild cognitive impairment, or probable Alzheimer's disease. These scans were then combined with gene expression data from over 3700 tissue samples through the Allen Human Brain Atlas data portal. From this data, the team was able to create a model that was able to predict the extent of cognitive decline from changes observed in the brain scans.

From these results, the team also identified eight genes that corresponded with cognitive changes in healthy controls, and 111 genes linked to cognitive changes in Alzheimer's disease. Sixty-five different biological pathways controlled by these genes were identified, and most were related to neurological and cognitive decline.

However, newly identified genes could assist in the development of new therapeutic targets to prevent Alzheimer's disease progression.

Senior author Dr Yasser Iturria-Medina, assistant professor in the department of neurology and neurosurgery, said 'Our study provides unprecedented insight into the multiscale interactions among ageing and Alzheimer's disease-associated biological factors and the possible mechanistic roles of the identified genes. This personalised model offers novel insights into the multiscale alterations in the elderly brain, with important implications for identifying targets for future treatments for Alzheimer's disease progression'.

The team will focus their future work on using personalised gene expression data from blood samples which could strengthen their model. They also plan to test this formula on other neurodegenerative disorders including Parkinson's disease and frontotemporal dementia.

This research was published in the journal eLife.

 12 
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Started by mensfe_admin - Last post by mensfe_admin
The HFEA legislations - recommendations was originally created in 1990 and has been revued on a regular basis to date.                       
However the question that was evident:
Is it fit for purpose in todays changing family structures ??

At Mensfe we found the (attached) overview of the seminar (organised by PETS) on this questions and related issues informative.

 13 
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Started by mensfe_admin - Last post by mensfe_admin
Professor Jackson discussed how one of the main challenges faced by the Warnock committee was coming up with realistic proposals when faced with morally challenging questions. The report identified the need for lay representation in regulation, the need for tough sanctions, and highlighted the benefits of using a code of practice within regulation that would allow flexibility and updates in regulation. Most challenging was the importance of drawing some lines and moral boundaries that could not and should not be crossed. The regulatory model created from the recommendations of the report has been very resilient and has worked for other non-departmental government bodies such as the Human Tissue Authority.

Professor Jackson noted that the Warnock Report was relatively progressive compared to the political background of the time where 'Victorian values' were being promoted. The Report does not suggest any statutory restrictions on treatments for single-sex households or homosexual couples, but instead suggests flexible and respectful legislation. The legacy of Baroness Warnock, concluded Professor Jackson, was in her placing value on expertise and demonstrating the benefits of a deliberative approach to law reform.

The next speaker was Professor Sarah Franklin, director of the University of Cambridge's Reproductive Sociology Research Group. Professor Franklin began by emphasising how the birth of Louise Brown was the 'birth of a "legal vacuum"' in which there was no legal precedent for the regulation of IVF, hence the importance of the Warnock Report.

Professor Franklin's talk focused on the 14-day rule suggested by the report, in which embryos can only be kept alive in laboratory conditions for up to 14 days. Professor Franklin argued that not only was this decision a scientific contract, but also a social one, drawing a clear line that would demonstrate that although 'controversial' research would be allowed to proceed, a strict limit would be enforced. The difficulty in drawing this line was that it would never be right for everyone, but even though the HFE Act has been amended the 14-day rule has – so far – endured. Moreover, it has been taken up as a 'default global standard' and has been used as a 'textbook case for developing successful regulatory policy', a testament to the Warnock Report.

The next speaker was Peter Thompson, chief executive of the HFEA, speaking of the impact of the Warnock Report on the HFEA. He explained that the HFEA's powers and work are a product of the Warnock Report, and of the consensus Baroness Warnock managed to forge. He praised the report's approach to scientific, regulatory, and social issues, while noting that its framework enables certain regulatory lines to be revisited, to take into account more recent developments.

Thompson spoke of how the regulatory regime initiated by the Warnock Report has stood the test of time remarkably well, and said that much of it continues to fulfil its purpose. Nonetheless, he added, it would be surprising if an exercise from the 1980s was not showing its age in 2021.

Finally, Professor Alison Murdoch, professor of reproductive medicine at Newcastle University, spoke from a clinical point of view of the impact of the Warnock Report. She said that Baroness Warnock and her colleagues took on a daunting task, and that their report was pragmatic and wise, having benefited patients, practitioners and researchers alike.

Professor Murdoch noted that at the moment, particularly in England, the provision of IVF is dominated by the private sector, and that many couples are childless because of their inability to access healthcare. To resolve this, she suggested that IVF should be considered more of a core service of the National Health Service (NHS).

Professor Murdoch argued that it was time for a thoroughgoing review of the HFE Act, because it needs more incremental adjustments, and there are problems that need 'putting right'. She acknowledged that challenging discussions would need to take place for any changes to be made, and acknowledged some apprehension about reopening the HFE Act in Parliament, but said there had been a shift in the public perception of assisted reproductive technologies and this needed to be taken into account.

Sarah Norcross then invited the audience to ask the panellists questions. Questions focused on changes in the fertility sector, and whether the HFEA's remit needs to be amended.Norcross posted a virtual poll, asking whether attendees thought there should be a new inquiry into the regulation of assisted reproduction and embryo research in the UK, similar to the Warnock committee. 81 percent of attendees stated that they thought there should be a new enquiry, and Norcross asked the panellists whether they agreed.

Thompson pointed out that if people wanted speedy change, that an expert committee was not the way to do this. The Warnock Report took two years to complete, and several more years before its recommendations were translated into legislation.

Baroness Ruth Deech, a former chair of the HFEA and a member of the House of Lords, was in attendance and said 'Parliament would be very reluctant to find time for another HFE Act after a Commission'. She argued that it was 'far better to keep extending whatever discretion there is in the Act and use regulations'. There would be significant challenges in establishing a new inquiry.

 14 
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Started by mensfe_admin - Last post by mensfe_admin
Ectogenesis:
12 April 2021 - by Professor John D Loike
Three new reports in Nature illuminate the potential to transform artificial wombs from a laboratory tool into a procedure to grow and maintain a human embryo from fertilisation until birth.

Two papers reported the generation of human blastocysts by culturing non-embryonic cells under specific conditions to transform them into blastocyst-like structures, called blastoids. In one study scientists treated stem cells derived from an established stem cell line with specific growth factors to generate the blastoids. In the second study, scientists used adult skin cells to reprogram them into blastoids. 

In the same issue, Nature reported that scientists have developed an artificial womb that allows the development of early mouse embryos into a fetus that contained fully formed organs. In this study, scientists at Weizmann Institute of Science implanted mouse blastocysts into their artificial placenta that contained special media and gases to study organ development, unconstrained by the need to image these structures inside a uterus. These mouse embryos were healthy until day 11 before dying, maintaining viable gestation for about halfway through the animals' normal 20-day gestation. I believe, it's only a matter of time when this technology will be further developed to generate healthy newborn pups.

Society needs to consider the potential health benefits emerging from these studies to decide whether the benefits trump ethical principles and guidelines. We need to consider the definition of humanhood, and the idea of generating a human being in the absence of a woman's body.

Generating and developing a human from fertilisation to 'birth' (especially in the absence of the sperm and egg) challenges our definition of what it means to be a human being. We believe a human being gestated in an artificial womb is still human and deserves human dignity. Humanhood, should not be restricted only to an organism born from a human but should include the generation of an organism that looks human and is composed of the essential genetic code of homo sapiens.

However, the cultural ethical challenges arising from this technology can be daunting. How will people feel if women don't need to become pregnant in order to produce children?  Many women feel biologically and psychologically connected to the fetus they are gestating. Moreover, the absence of human pregnancy may impact epigenetic processes and change the mother-child bonding. One could argue, however, that pregnancy may not be a critical process for human development and bonding, since normal human development occurs post-gestationally, in many families that have adopted children. In addition, the burden of medical responsibility for maintaining these embryos in an artificial placenta would fall on our overloaded hospital system. Should health insurance fund this technology?

In addition, it is important that regulators, politicians, physicians, scientists, religious scholars, and concerned citizens reflect on the nature of the internationally accepted '14-day rule,' which limits the growth of artificially generated human embryos for more than 14 days, when normally the primitive streak appears in the embryo, which is a band of cells that forms and is regarded as a precursor of the neural tube and nervous system. Both Nature reports were mindful of this 14-day rule and did not maintain these artificially generated embryos past 14 days.

The use of stem cell lines or adult cells, rather than sperm and eggs, avoids one important ethical issue associated with early human embryological research – the destruction of a traditional human embryo. Normally, premature embryos that gestate in utero less than 25 weeks face serious, if not fatal, consequences. The Nature ectogenesis article coupled with a previous report on how to better maintain premature sheep fetuses in an artificial womb may help us learn how to maintain the health and development of premature human fetuses. However, a profound ethical issue arises if scientists combine the two technologies (ie, generating human blastocyts from skin cells or stem cell lines and the artificial placenta). Attempting to gestate an embryo in vitro, from start to finish, sets the stage for a revolution in human gestation. 

Because of the complex nature of ethical ectogenesis, it would be appropriate for the US National Academy of Science to organise a committee to examine these ethical issues, decide whether there should be limits on scientific ectogenesis research, and propose policies to guide decision-making. Perhaps, at this time research should focus only on the use of ectogenesis in treating premature fetuses and restrict the development of creating a completely viable artificial placenta. In an era of rapidly advancing science, our experts at the National Academy of Science should be proactive in providing research guidelines regarding ectogenesis.               

 15 
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Started by mensfe_admin - Last post by mensfe_admin
Ectogenesis: ethical challenges in creating artificial wombs
12 April 2021 - by Professor John D Loike
Three new reports in Nature illuminate the potential to transform artificial wombs from a laboratory tool into a procedure to grow and maintain a human embryo from fertilisation until birth.

Two papers reported the generation of human blastocysts by culturing non-embryonic cells under specific conditions to transform them into blastocyst-like structures, called blastoids. In one study scientists treated stem cells derived from an established stem cell line with specific growth factors to generate the blastoids. In the second study, scientists used adult skin cells to reprogram them into blastoids.  

In the same issue, Nature reported that scientists have developed an artificial womb that allows the development of early mouse embryos into a fetus that contained fully formed organs. In this study, scientists at Weizmann Institute of Science implanted mouse blastocysts into their artificial placenta that contained special media and gases to study organ development, unconstrained by the need to image these structures inside a uterus. These mouse embryos were healthy until day 11 before dying, maintaining viable gestation for about halfway through the animals' normal 20-day gestation. I believe, it's only a matter of time when this technology will be further developed to generate healthy newborn pups.

Society needs to consider the potential health benefits emerging from these studies to decide whether the benefits trump ethical principles and guidelines. We need to consider the definition of humanhood, and the idea of generating a human being in the absence of a woman's body.

Generating and developing a human from fertilisation to 'birth' (especially in the absence of the sperm and egg) challenges our definition of what it means to be a human being. We believe a human being gestated in an artificial womb is still human and deserves human dignity. Humanhood, should not be restricted only to an organism born from a human but should include the generation of an organism that looks human and is composed of the essential genetic code of homo sapiens.

However, the cultural ethical challenges arising from this technology can be daunting. How will people feel if women don't need to become pregnant in order to produce children?  Many women feel biologically and psychologically connected to the fetus they are gestating. Moreover, the absence of human pregnancy may impact epigenetic processes and change the mother-child bonding. One could argue, however, that pregnancy may not be a critical process for human development and bonding, since normal human development occurs post-gestationally, in many families that have adopted children. In addition, the burden of medical responsibility for maintaining these embryos in an artificial placenta would fall on our overloaded hospital system. Should health insurance fund this technology?

In addition, it is important that regulators, politicians, physicians, scientists, religious scholars, and concerned citizens reflect on the nature of the internationally accepted '14-day rule,' which limits the growth of artificially generated human embryos for more than 14 days, when normally the primitive streak appears in the embryo, which is a band of cells that forms and is regarded as a precursor of the neural tube and nervous system. Both Nature reports were mindful of this 14-day rule and did not maintain these artificially generated embryos past 14 days.

The use of stem cell lines or adult cells, rather than sperm and eggs, avoids one important ethical issue associated with early human embryological research – the destruction of a traditional human embryo. Normally, premature embryos that gestate in utero less than 25 weeks face serious, if not fatal, consequences. The Nature ectogenesis article coupled with a previous report on how to better maintain premature sheep fetuses in an artificial womb may help us learn how to maintain the health and development of premature human fetuses. However, a profound ethical issue arises if scientists combine the two technologies (ie, generating human blastocyts from skin cells or stem cell lines and the artificial placenta). Attempting to gestate an embryo in vitro, from start to finish, sets the stage for a revolution in human gestation.  

Because of the complex nature of ethical ectogenesis, it would be appropriate for the US National Academy of Science to organise a committee to examine these ethical issues, decide whether there should be limits on scientific ectogenesis research, and propose policies to guide decision-making. Perhaps, at this time research should focus only on the use of ectogenesis in treating premature fetuses and restrict the development of creating a completely viable artificial placenta. In an era of rapidly advancing science, our experts at the National Academy of Science should be proactive in providing research guidelines regarding ectogenesis.                

 16 
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Started by mensfe_admin - Last post by mensfe_admin
We at Mensfe endorse this very enlightening post
Well done - Cecile and Seb.

 17 
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Started by mensfe_admin - Last post by mensfe_admin
1 February 2021 - by Jen Willows
A new research paper warns that COVID-19 can affect men's sperm, but it may not be that simple.

Researchers from the Justus-Liebig University in Giessen, Germany published a study in Reproduction, showing that the sperm of men who had been diagnosed with COVID-19 showed increased sperm cell death, inflammation and oxidative stress compared to the sperm of men who had not had the virus.

'These effects on sperm cells are associated with lower sperm quality and reduced fertility potential' said lead researcher Behzad Hajizadeh Maleki. 'Although these effects tended to improve over time, they remained significantly and abnormally higher in the COVID-19 patients, and the magnitude of these changes were also related to disease severity.'

The research looked at sperm samples from 84 men who previously had COVID-19 and 105 who had not. Samples were collected every ten days for 60 days, and were screened for a number of indicators of sperm quality. On average, the samples from men who had been ill with COVID-19 had reduced sperm concentration and mobility, and had four times more misshapen sperm.

It is known that the cells in the testes have the ACE2 receptor, which the SARS-CoV-2 virus uses to infect cells. This issue was discussed in December at the annual conference of the Progress Educational Trust (PET) – the charity that publishes BioNews (see BioNews 1077). However, it is unknown if this is related to the effect on sperm.

'Being ill from any virus such as flu can temporarily drop your sperm count (sometimes to zero) for a few weeks or months. This makes it difficult to work out how much of the reductions observed in this study were specific to COVID-19 rather than just from being ill' said Dr Channa Jayasena, a reproductive endocrinology and andrology specialist from Imperial College London, who was not involved in the study.

Professor Allan Pacey who spoke at the PET conference pointed out that 'sperm production takes just under three months (roughly) to be completed from start to finish... It would have been more useful to see whether there was a difference at 90 days between the two groups.'

He also added that the men with COVID-19 had been hospitalised and would have been given a number of medications, which the control group were not.

 18 
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Started by mensfe_admin - Last post by mensfe_admin
1 February 2021 - by Jen Willows
A new research paper warns that COVID-19 can affect men's sperm, but it may not be that simple.

Researchers from the Justus-Liebig University in Giessen, Germany published a study in Reproduction, showing that the sperm of men who had been diagnosed with COVID-19 showed increased sperm cell death, inflammation and oxidative stress compared to the sperm of men who had not had the virus.

'These effects on sperm cells are associated with lower sperm quality and reduced fertility potential' said lead researcher Behzad Hajizadeh Maleki. 'Although these effects tended to improve over time, they remained significantly and abnormally higher in the COVID-19 patients, and the magnitude of these changes were also related to disease severity.'

The research looked at sperm samples from 84 men who previously had COVID-19 and 105 who had not. Samples were collected every ten days for 60 days, and were screened for a number of indicators of sperm quality. On average, the samples from men who had been ill with COVID-19 had reduced sperm concentration and mobility, and had four times more misshapen sperm.

It is known that the cells in the testes have the ACE2 receptor, which the SARS-CoV-2 virus uses to infect cells. This issue was discussed in December at the annual conference of the Progress Educational Trust (PET) – the charity that publishes BioNews (see BioNews 1077). However, it is unknown if this is related to the effect on sperm.

'Being ill from any virus such as flu can temporarily drop your sperm count (sometimes to zero) for a few weeks or months. This makes it difficult to work out how much of the reductions observed in this study were specific to COVID-19 rather than just from being ill' said Dr Channa Jayasena, a reproductive endocrinology and andrology specialist from Imperial College London, who was not involved in the study.

Professor Allan Pacey who spoke at the PET conference pointed out that 'sperm production takes just under three months (roughly) to be completed from start to finish... It would have been more useful to see whether there was a difference at 90 days between the two groups.'

He also added that the men with COVID-19 had been hospitalised and would have been given a number of medications, which the control group were not.

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Started by mensfe_admin - Last post by mensfe_admin

1 February 2021 - by Professor Frances Flinter
In order to be approved for use in the UK, vaccines must meet the strict standards of safety, quality and effectiveness set out by the independent Medicines and Healthcare products Regulatory Agency. Any COVID-19 vaccine that is approved must go through the same clinical trials and safety checks as all other licensed medicines.

Vaccines that are approved will have been through three phases of clinical trials. In Phase 1 and Phase 2 trials, vaccines are tested on small numbers of volunteers to check they are safe and to determine the optimum dose. In Phase 3 trials they are tested in thousands of people to see how effective they are. The group that receives the vaccine and a control group that receives a placebo (either saline or a different vaccine) are closely monitored for any adverse reactions or side-effects. Safety monitoring continues after a vaccine has been approved for use.

Conventional vaccines contain inactivated versions of whatever pathogen causes the disease, or the proteins on its surface, triggering an immune response in the body that enables it to fight the real infection subsequently.

Two of the COVID-19 vaccines that have recently been approved for use in the UK were developed using a novel technology that uses RNA. RNA vaccines are also being developed for the treatment of cancer. The approved RNA vaccines are made by Pfizer-BioNTech and Moderna: 43,500 people were involved in the Pfizer-BioNTech trial and 30,000 in the Moderna trial. Safety was closely monitored throughout and there were no serious side-effects.

So far, several million people have now been given a COVID-19 vaccine with very few reports of significant side effects, such as allergic reactions.

A posting on Facebook made the following false claim: 'The COVID vaccine is an RNA vaccine. This will actually change your DNA.'

RNA is an acronym for ribonucleic acid, a nucleic acid. RNA is physically different from DNA: DNA contains two intercoiled strands (a double helix), whereas RNA only contains one single strand. RNA also contains two different bases from DNA – its chemical constituents are different.

The main function of RNA is to carry instructions about the amino acid sequences needed to make proteins from the genes (made of DNA) in the cell nucleus to the cytoplasm, where the proteins are assembled on structures called ribosomes. This communication takes place by messenger RNA (mRNA), which translates the sequence of base pairs in the relevant part of the DNA into a corresponding sequence of the amino acids that will join up to form proteins in a process called translation.

RNA vaccines, such as those made by Pfizer-BioNTech and Moderna, contain synthetic mRNA, which codes for a protein specific to the coronavirus's surface. The body uses this mRNA to build its own copies of these proteins to which the immune system then responds by producing antibodies. This gives the immunised person protection if they are exposed to the real virus later – in this case, SARS-CoV-2, the virus which leads to COVID-19.

RNA vaccines are not made with viral particles or inactivated virus, so they are non-infectious. RNA does not integrate itself into the host genome (DNA) and the RNA strand in the vaccine is degraded once the protein has been made. The introduction of mRNA into human cells does not change the DNA of these cells and if these cells replicate, the mRNA would not be incorporated into the new cells' genetic information.

In addition to the advantages of safety, clinical trials show that RNA vaccines generate a reliable immune response and are well-tolerated. Furthermore, RNA vaccines can be produced cheaply and rapidly and can be adjusted easily, if necessary, to accommodate any future significant mutations that may occur in the virus. RNA vaccines are also faster and cheaper to produce than traditional vaccines.

COVID-19 has caused over two million deaths around the world and caused many more people to suffer long term harm to their health, while no-one has died or even experienced a serious adverse event following vaccination. If we are to escape from the terrible pandemic, which has now reached almost every country in the world, it is essential that people have confidence in the safe and effective vaccines that have been developed at such remarkable speed without cutting any corners.

People who spread false rumours raising concerns about their safety are not only being irresponsible, but they also risk endangering the lives of others. We are incredibly lucky that scientists have developed vaccines that are both safe and significantly more effective than older vaccines (for example flu vaccines) and it is imperative that, once they are available, as many people as possible accept them.

The author works in a COVID-19 vaccination centre and has had one dose of the Pfizer BioNTech vaccine.

 20 
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Started by mensfe_admin - Last post by mensfe_admin

The COVID Vaccine: A Shot in the Arm for Fertility Treatment?
8 February 2021 - by Dr Ëlo Luik
The rollout of COVID vaccination programmes has brought with it a renewed hope of a return to normality but has also raised questions about the impact of vaccination on fertility treatment and pregnancy.

To help explain and clarify the advice to fertility patients and clinicians, and to fight misinformation spreading online, the Progress Educational Trust (PET) – the charity that publishes BioNew – held an online event.

'The COVID-19 Vaccine: A Shot in the Arm for Fertility Treatment?' was chaired by PET's director Sarah Norcross, and featured speakers outlining the approaches taken by UK, EU and US bodies.

Professor Jason Kasraie, chair of the Association of Reproductive and Clinical Scientists (ARCS), gave the first presentation – an overview of the UK guidance issued by ARCS and the British Fertility Society (BFS). He emphasised that there is no known risk in giving non-live vaccines to pregnant women or those looking to conceive.

ARCS and BFS say there is no need to avoid pregnancy after vaccination, and women who would benefit from the vaccine should receive it without compromising their planned fertility treatment. However, as with any medical treatment, patients should be involved in the decisionmaking process. Pointing out the prevalence of fearmongering misinformation online, Professor Kasraie stressed the importance of being careful about how risk is communicated, when there is currently no cause for fear.

The next speaker, Dr Anna Veiga, coordinator of the European Society of Human Reproduction and Embryology (ESHRE)'s COVID-19 Working Group, explained that ESHRE's relatively cautious position relates to an absence of concrete evidence.

ESHRE has decided not to offer a universal recommendation on whether or not men and women attempting assisted conception should get vaccinated before starting treatment, and instead emphasises the importance of weighing up the factors that are relevant to each individual patient. ESHRE recommends postponing the start of fertility treatment for at least a few days after the vaccine, to allow the immune response to settle.

Regarding vaccination and pregnancy, ESHRE suggests that pregnant women should not be vaccinated unless they are at particularly high risk. ESHRE also suggests that if a woman becomes pregnant after receiving the first vaccine dose then, then – unless the woman is at particularly high risk – the second dose should be delayed until the pregnancy is over. There is no advice to avoid pregnancy after vaccination.

Despite this cautious approach towards the vaccine, Dr Veiga noted that pregnant women have been shown to be at higher risk of developing severe COVID-19 compared to non-pregnant women. Women may therefore still decide to go ahead with vaccination, since the benefits of protection from COVID-19 might outweigh any theoretical risks from, vaccination.

Dr Sigal Klipstein, member of the American Society of Reproductive Medicine (ASRM)'s COVID-19 Task Force, explained that the ASRM's more permissive advice is based on assessing the known and very real risks of COVID-19 alongside the largely theoretical risks of the vaccine. As such, the ASRM recommends vaccination to everyone who can access the vaccine – whether before or during pregnancy – on the grounds that the benefits outweigh the risks.

To emphasise this point, Dr Klipstein gave the example of Israel's decision to make pregnant women a priority group for vaccination, due to their increased risk of developing severe COVID-19. Dr Klipstein further emphasised the important role of fertility specialists in promoting vaccination to their patients, their communities and the public, so as to counter worrying trends of vaccine hesitancy.

During the event, attendees were polled on whether they thought a consensus was needed between all relevant professional bodies on the COVID vaccine and fertility treatment. A clear majority (77 percent) voted yes, prompting Norcross to ask the panel if there was any hope of a consensus being worked out. All three speakers agreed that a uniform message would help avoid confusion and vaccine hesitancy, but that it would be difficult to achieve a consensus, due to each national body's need to follow the formal position of their country's health authorities. The speakers did, however, note that there was significant agreement on key points.

While most of the discussion focused on vaccination of women and the impact on pregnancy, there was an audience question about the impact vaccination might have on sperm quality. The panel agreed that there is no suggestion of risk to the quality of sperm, but that it might be beneficial for men to leave some time between vaccination and fertility treatment, simply to avoid any temporary side effects of the vaccine (such as a fever) having an effect on sperm production. However, it remains prudent for men to get vaccinated before a planned conception, not least so that they avoid the risk of transmitting COVID-19 to the pregnant woman.

Several audience questions addressed the lack of evidence available on the impact of the vaccine. The panel agreed that while there is currently little evidence on the impact of the vaccines on IVF treatment, gamete donation or the health of newborns, there is new information coming in constantly and at unprecedented speeds. Studies of long-term effects will by their nature take time, but there is reassurance to be drawn from studies undertaken on other non-live vaccines.

Dr Klipstein warned against the temptation of an overabundance of caution in the absence of data, as this could end up forcing women into an impossible scenario of weighing up the risk posed by COVID-19 to their own health with any theoretical risks to their baby from the vaccine. Professor Kasraie observed that IVF patients are known to be especially anxious during the pregnancy, so placing them in a position where they have to shield throughout the nine months of pregnancy – for fear of catching COVID-19 – could exacerbate their isolation and anxiety.

Overall, the event showed that despite some differences in the advice given by UK, EU and US bodies, there is significant agreement on the important role of vaccination in protecting the health of fertility patients and professionals alike. Evidence of the harm that can be caused by COVID-19 during pregnancy is clear, known and real. Evidence of harm that can be caused by COVID vaccines is at best theoretical and unsupported by evidence. Certain precautions may be taken in the absence of data, but it is important to ensure that such precautions are not taken to be an indication that there is a known risk.

PET is grateful to the Edwards and Steptoe Research Trust Fund, the British Fertility Society, the Bristol Fertility Clinic and CooperSurgical for supporting this event.

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