- Welcome to The Mens Fertility Forum - Mensfe .
Recent posts
#1
General Discussion / Re: HFEA Changes Surrogacy Rul...
Last post by mensfe_admin - 2025-12-10 17:16"Yes, a patient can transport frozen eggs (oocytes) or embryos from the UK to the USA, but it's a highly regulated process requiring coordination with specialist couriers, compliance with both UK (HFEA) and US (FDA) rules, proper cryo-shipping in liquid nitrogen tanks, and specific infectious disease testing. The process involves the UK clinic, the receiving US clinic, and an expert courier managing documentation, customs, and maintaining the cold chain for the samples.
Key Requirements & Steps:
1. FDA Compliance (US Side): The primary hurdle for US entry is that donors must have completed specific FDA-required infectious disease screening (HIV, Hepatitis, Syphilis, Chlamydia, Gonorrohea) at an FDA-certified US facility at the time of donation.
2. HFEA Compliance (UK Side): The UK clinic must follow Human Fertilisation and Embryology Authority (HFEA) regulations for exporting gametes, ensuring donor consent and proper quality standards.
3. Specialist Courier: You need a licensed courier (e.g., Embryoport, Greenplace Healthcare, Biocair ) specialising in cryogenic transport (using LN2 dewars) and handling international paperwork.
4. Clinic Coordination: Both the UK exporting clinic and the US receiving clinic must work together to arrange the transfer and paperwork.
5. Documentation & Customs: The courier manages the extensive documentation, permits, and customs clearance.
Process Summary:
• Frozen eggs are placed in specialised liquid nitrogen shippers.
• A specialist courier transports them directly from the UK clinic to the US clinic.
• The receiving US clinic verifies the FDA-compliant testing results.
In short, it's possible but complex, requiring expert logistical and regulatory support from your clinics and a specialised courier. "
Key Requirements & Steps:
1. FDA Compliance (US Side): The primary hurdle for US entry is that donors must have completed specific FDA-required infectious disease screening (HIV, Hepatitis, Syphilis, Chlamydia, Gonorrohea) at an FDA-certified US facility at the time of donation.
2. HFEA Compliance (UK Side): The UK clinic must follow Human Fertilisation and Embryology Authority (HFEA) regulations for exporting gametes, ensuring donor consent and proper quality standards.
3. Specialist Courier: You need a licensed courier (e.g., Embryoport, Greenplace Healthcare, Biocair ) specialising in cryogenic transport (using LN2 dewars) and handling international paperwork.
4. Clinic Coordination: Both the UK exporting clinic and the US receiving clinic must work together to arrange the transfer and paperwork.
5. Documentation & Customs: The courier manages the extensive documentation, permits, and customs clearance.
Process Summary:
• Frozen eggs are placed in specialised liquid nitrogen shippers.
• A specialist courier transports them directly from the UK clinic to the US clinic.
• The receiving US clinic verifies the FDA-compliant testing results.
In short, it's possible but complex, requiring expert logistical and regulatory support from your clinics and a specialised courier. "
#2
General Discussion / Re: HFEA Changes Surrogacy Rul...
Last post by mensfe_admin - 2025-12-10 17:14Patient experience - "Theoretically, this is possible and we have both imported and exported to the States. They would need to be registered with an American clinic and have had a consultation there. There's usually consent and admin charges that would need to be paid to the UK clinic before they would be happy to send information over. The UK clinic would need to send freeze details, consents and virologies, but the American clinic would also have to provide information on their accreditation, quality management and traceability and this would have to meet HFEA guidelines to be able to export there. If these cannot be met, they could apply to the HFEA for special directions, but they may not grant this. Regulations between the countries vary and they would not be able to use the eggs for anything that is illegal within the UK, the most common being sex selection."
#3
General Discussion / HFEA Changes Surrogacy Rules o...
Last post by mensfe_admin - 2025-12-10 17:10|
Fertility Blog
Blog originally published by American Society for Reproductive Medicine (ASRM)
The United Kingdom's fertility regulator, the Human Fertilisation and Embryology Authority (HFEA), is updating its guidance on exporting eggs, sperm and embryos for surrogacy. It means that U.K. intended parents who wish to transport their gametes or embryos to clinics in the United States to conceive with a gestational carrier will now be able to arrange export much more straightforwardly.
Although export from the U.K. for the purposes of surrogacy has never been illegal, there are some complex regulatory rules which U.K. fertility clinics are obliged by law to follow which have in practice caused a block until now. To arrange export (without needing specific advance permission from the HFEA), U.K. fertility clinics must show the export falls within the rules of the HFEA General Direction on export. The General Direction creates a list of tick-boxes which, as well as confirming the safety and quality standards at the receiving clinic and patient consent, requires clinics to satisfy themselves that the treatment planned overseas would not be "unlawful" in the U.K.
This has long been a sticking point in surrogacy cases. U.K. law prohibits profit-making surrogacy agencies from operating in the U.K. and encourages the payment of no more than reasonable expenses to surrogates (although paying compensation is not illegal, and, in reality, the family court has the power to authorise surrogate compensation when awarding parentage and routinely does). As a result, many U.K. fertility clinics have been hesitant to export embryos or gametes overseas where "commercial" surrogacy is planned, fearing that this would breach the requirement in the General Direction about unlawfulness.
Previously, the HFEA guidance to U.K. fertility clinics added to the concern, since the HFEA advised that, before exporting gametes or embryos for surrogacy, U.K. clinics should ask patients whether the intention was to involve a commercial surrogacy agency or to compensate the surrogate. Although the HFEA was not clear about the implications of an affirmative answer, the fact that such questions were required was taken by most U.K. clinics as confirmation that export was not permitted where "commercial" surrogacy was planned.
In 2020, the pandemic threw a brighter spotlight on the problem, since intended parents who would have previously travelled to the U.S. (and elsewhere) for surrogacy, were suddenly not able to get there in person. More looked to U.K. fertility clinics to help them ship their sperm or embryos to the U.S. instead to enable them to conceive through gestational surrogacy. The confusion around the export rules, and the block this created in practice, suddenly became much more obvious and problematic.
This author's fertility law firm, NGA Law, and U.K. surrogacy organisation, Brilliant Beginnings, therefore made a joint approach to the HFEA to challenge its legal interpretation and ask them to clarify that clinics could export under the General Direction even if "commercial" surrogacy abroad was planned. We set out our case that, although the law in the U.K. prohibits professionally arranged surrogacy in the U.K., the parameters of unlawfulness are narrow and only catch the activities of surrogacy agencies operating for profit in the U.K. The arguments made were that there is no unlawfulness around fertility clinics offering treatment, surrogacy agencies operating commercially outside the U.K., or intended parents/surrogates themselves making or receiving payments. Therefore, we argued that the General Direction requirement not to export for "treatment services" which would be unlawful in the U.K. was not breached if intended parents from the U.K. wanted to engage in commercial surrogacy overseas.
HFEA Chief Executive, Peter Thompson, responded in October 2020 that, having reflected, and taken legal advice, the HFEA agreed with our interpretation. It was not in fact unlawful for clinics to provide treatment services for surrogacy where there was a wider commercial element (even in the U.K.), and therefore U.K. clinics also could export gametes and embryos for surrogacy in compliance with the General Direction rules without needing to ask patients about whether any commercial elements were involved overseas.
The wider context here is that attitudes toward commercial surrogacy have evolved in the U.K. over the past 15 years. International surrogacy is now an established and accepted way of building a family for U.K. parents, and one routinely authorised by the family court. Around half the parentage orders made in the U.K. in surrogacy cases now involve children born overseas through "commercial" surrogacy – around 200 cases a year – and there are no cases where the court has refused to award parentage to U.K. parents who have used a professional agency or compensated a surrogate. International surrogacy was even recently endorsed by the U.K. Supreme Court which (in awarding damages for negligence to cover the cost of surrogacy in California) ruled explicitly that international commercial surrogacy was no longer contrary to U.K. public policy, provided that the country in question had a well-established system which properly safeguarded the interests of all involved. Although the update to the HFEA guidance is a clarification rather than a change of policy, it is in line with this wider trend.
Going forward, U.K. fertility clinics will now be able to export eggs, sperm or embryos for patients wishing to pursue surrogacy under the General Direction rules. They do not need advance permission from the HFEA and there is no need for them to ask whether their patients plan to involve a paid surrogacy agency or a compensated surrogate. They just need to liaise with the receiving clinic overseas to confirm they meet all the right quality standards and confirm that the patients consent to the export, something which should be straightforward in most cases involving U.S. fertility clinics.
Although it will take some time for the HFEA to review and update its formal published guidance on export, HFEA Chief Executive, Peter Thompson, has explicitly confirmed in his letter to NGA Law and Brilliant Beginnings that the change is of immediate effect. This is good news for patients wishing to export their eggs, sperm or embryos overseas for the purposes of international surrogacy, who can now be confident in their ability to do so in the midst of a pandemic even if they cannot travel themselves.
Guest Author, U.K. Solicitor, Natalie Gamble, is the principal of NGA Law, which represents and advocates for clients building families through ART and surrogacy, and a founder of Brilliant Beginnings, a non-profit surrogacy agency known for its policy and campaigning work and support of U.K. parents engaging in surrogacy in the U.K., U.S., and Canada.
Fertility Blog
Blog originally published by American Society for Reproductive Medicine (ASRM)
The United Kingdom's fertility regulator, the Human Fertilisation and Embryology Authority (HFEA), is updating its guidance on exporting eggs, sperm and embryos for surrogacy. It means that U.K. intended parents who wish to transport their gametes or embryos to clinics in the United States to conceive with a gestational carrier will now be able to arrange export much more straightforwardly.
Although export from the U.K. for the purposes of surrogacy has never been illegal, there are some complex regulatory rules which U.K. fertility clinics are obliged by law to follow which have in practice caused a block until now. To arrange export (without needing specific advance permission from the HFEA), U.K. fertility clinics must show the export falls within the rules of the HFEA General Direction on export. The General Direction creates a list of tick-boxes which, as well as confirming the safety and quality standards at the receiving clinic and patient consent, requires clinics to satisfy themselves that the treatment planned overseas would not be "unlawful" in the U.K.
This has long been a sticking point in surrogacy cases. U.K. law prohibits profit-making surrogacy agencies from operating in the U.K. and encourages the payment of no more than reasonable expenses to surrogates (although paying compensation is not illegal, and, in reality, the family court has the power to authorise surrogate compensation when awarding parentage and routinely does). As a result, many U.K. fertility clinics have been hesitant to export embryos or gametes overseas where "commercial" surrogacy is planned, fearing that this would breach the requirement in the General Direction about unlawfulness.
Previously, the HFEA guidance to U.K. fertility clinics added to the concern, since the HFEA advised that, before exporting gametes or embryos for surrogacy, U.K. clinics should ask patients whether the intention was to involve a commercial surrogacy agency or to compensate the surrogate. Although the HFEA was not clear about the implications of an affirmative answer, the fact that such questions were required was taken by most U.K. clinics as confirmation that export was not permitted where "commercial" surrogacy was planned.
In 2020, the pandemic threw a brighter spotlight on the problem, since intended parents who would have previously travelled to the U.S. (and elsewhere) for surrogacy, were suddenly not able to get there in person. More looked to U.K. fertility clinics to help them ship their sperm or embryos to the U.S. instead to enable them to conceive through gestational surrogacy. The confusion around the export rules, and the block this created in practice, suddenly became much more obvious and problematic.
This author's fertility law firm, NGA Law, and U.K. surrogacy organisation, Brilliant Beginnings, therefore made a joint approach to the HFEA to challenge its legal interpretation and ask them to clarify that clinics could export under the General Direction even if "commercial" surrogacy abroad was planned. We set out our case that, although the law in the U.K. prohibits professionally arranged surrogacy in the U.K., the parameters of unlawfulness are narrow and only catch the activities of surrogacy agencies operating for profit in the U.K. The arguments made were that there is no unlawfulness around fertility clinics offering treatment, surrogacy agencies operating commercially outside the U.K., or intended parents/surrogates themselves making or receiving payments. Therefore, we argued that the General Direction requirement not to export for "treatment services" which would be unlawful in the U.K. was not breached if intended parents from the U.K. wanted to engage in commercial surrogacy overseas.
HFEA Chief Executive, Peter Thompson, responded in October 2020 that, having reflected, and taken legal advice, the HFEA agreed with our interpretation. It was not in fact unlawful for clinics to provide treatment services for surrogacy where there was a wider commercial element (even in the U.K.), and therefore U.K. clinics also could export gametes and embryos for surrogacy in compliance with the General Direction rules without needing to ask patients about whether any commercial elements were involved overseas.
The wider context here is that attitudes toward commercial surrogacy have evolved in the U.K. over the past 15 years. International surrogacy is now an established and accepted way of building a family for U.K. parents, and one routinely authorised by the family court. Around half the parentage orders made in the U.K. in surrogacy cases now involve children born overseas through "commercial" surrogacy – around 200 cases a year – and there are no cases where the court has refused to award parentage to U.K. parents who have used a professional agency or compensated a surrogate. International surrogacy was even recently endorsed by the U.K. Supreme Court which (in awarding damages for negligence to cover the cost of surrogacy in California) ruled explicitly that international commercial surrogacy was no longer contrary to U.K. public policy, provided that the country in question had a well-established system which properly safeguarded the interests of all involved. Although the update to the HFEA guidance is a clarification rather than a change of policy, it is in line with this wider trend.
Going forward, U.K. fertility clinics will now be able to export eggs, sperm or embryos for patients wishing to pursue surrogacy under the General Direction rules. They do not need advance permission from the HFEA and there is no need for them to ask whether their patients plan to involve a paid surrogacy agency or a compensated surrogate. They just need to liaise with the receiving clinic overseas to confirm they meet all the right quality standards and confirm that the patients consent to the export, something which should be straightforward in most cases involving U.S. fertility clinics.
Although it will take some time for the HFEA to review and update its formal published guidance on export, HFEA Chief Executive, Peter Thompson, has explicitly confirmed in his letter to NGA Law and Brilliant Beginnings that the change is of immediate effect. This is good news for patients wishing to export their eggs, sperm or embryos overseas for the purposes of international surrogacy, who can now be confident in their ability to do so in the midst of a pandemic even if they cannot travel themselves.
Guest Author, U.K. Solicitor, Natalie Gamble, is the principal of NGA Law, which represents and advocates for clients building families through ART and surrogacy, and a founder of Brilliant Beginnings, a non-profit surrogacy agency known for its policy and campaigning work and support of U.K. parents engaging in surrogacy in the U.K., U.S., and Canada.
#4
General Discussion / A Journey Through Male Inferti...
Last post by mensfe_admin - 2025-11-19 10:23Hi all you Mensfe readers
Its MENS DAY
Not sure what that means other than the media hopefully high profiling men's issues: We have just put a Guide Book together which will be published (1-12-2025) via Amazon it's called:
A JOURNEY THROUGH MALE INFERTILITY
Stronger together
A BOOK FOR MEN THAT WOMEN SHOULD READ
It's 21 chapters that address all aspects of the emotional weight of Infertility, including: Male and Female Ideology - Redefining Gender Roles - The Treatment Pathway - Diagnosis - The Significance of Fatherhood - Need for Change - Rediscovering Joy, to name a few.
Primarily, it is a support guidebook for you, by you.
Its MENS DAY
Not sure what that means other than the media hopefully high profiling men's issues: We have just put a Guide Book together which will be published (1-12-2025) via Amazon it's called:
A JOURNEY THROUGH MALE INFERTILITY
Stronger together
A BOOK FOR MEN THAT WOMEN SHOULD READ
It's 21 chapters that address all aspects of the emotional weight of Infertility, including: Male and Female Ideology - Redefining Gender Roles - The Treatment Pathway - Diagnosis - The Significance of Fatherhood - Need for Change - Rediscovering Joy, to name a few.
Primarily, it is a support guidebook for you, by you.
#5
General Discussion / Childless
Last post by mensfe_admin - 2025-07-20 09:49Hi Mensfe readers - we do not normally post the following request however the following may be of interest to some of you.
Good luck to your production and informative support on this very important subject: P. Mensfe.
I just wanted to let Mensfe know about Empty, my play about unwanted childlessness, which is getting an airing at the Cockpit on 7 September at 5.30pm. A two-hander, it's being performed as part of the London theatre's New Stuff programme. It would be lovely if you were able to give it a mention or, even better, come along to see it - and offer support! I'll probably be quaking in my boots! The theatre is near Marylebone Station.
It's actually a 40-minute extract taken from the complete play, which is an hour and a half long. As Empty is still in the development stage, it will be a rehearsed reading – that is, the two actors will be acting but will have the script to hand. I am so honoured that Empty has been chosen for performance, along with a second play by another playwright the same evening.
And I'm so lucky to have two wonderful actors playing the roles of Amy and Dave – Melanie Dagg and Tim Treloar, both childless. I can't wait to hear them get hold of my words and give them some heartfelt Geordie and Welsh energy.
Here's the post on the Cockpit website:
https://www.thecockpit.org.uk/show/new_stuff_september_0
It's where you can buy tickets for the princely sum of £3! After the play there will be a Q&A session and a more informal one in the bar at the end of the evening.
A shorter extract from Empty will be performed at Storyhouse Childless on the evening of 13 September.
All best wishes,
Robert
My latest book, 'I Always Wanted To Be A Dad: Men Without Children', is now available in hardback, paperback or as an eBook from Amazon, my website (robertnurden.com) or from bookshops.
Website: robertnurden.com
Good luck to your production and informative support on this very important subject: P. Mensfe.
I just wanted to let Mensfe know about Empty, my play about unwanted childlessness, which is getting an airing at the Cockpit on 7 September at 5.30pm. A two-hander, it's being performed as part of the London theatre's New Stuff programme. It would be lovely if you were able to give it a mention or, even better, come along to see it - and offer support! I'll probably be quaking in my boots! The theatre is near Marylebone Station.
It's actually a 40-minute extract taken from the complete play, which is an hour and a half long. As Empty is still in the development stage, it will be a rehearsed reading – that is, the two actors will be acting but will have the script to hand. I am so honoured that Empty has been chosen for performance, along with a second play by another playwright the same evening.
And I'm so lucky to have two wonderful actors playing the roles of Amy and Dave – Melanie Dagg and Tim Treloar, both childless. I can't wait to hear them get hold of my words and give them some heartfelt Geordie and Welsh energy.
Here's the post on the Cockpit website:
https://www.thecockpit.org.uk/show/new_stuff_september_0
It's where you can buy tickets for the princely sum of £3! After the play there will be a Q&A session and a more informal one in the bar at the end of the evening.
A shorter extract from Empty will be performed at Storyhouse Childless on the evening of 13 September.
All best wishes,
Robert
My latest book, 'I Always Wanted To Be A Dad: Men Without Children', is now available in hardback, paperback or as an eBook from Amazon, my website (robertnurden.com) or from bookshops.
Website: robertnurden.com
#6
General Discussion / An open letter to the HFEA abo...
Last post by mensfe_admin - 2025-06-30 20:53Comment
The following letter has been sent to Peter Thompson, chief executive of the Human Fertilisation and Embryology Authority (HFEA).
Dear Peter,
Thank you for your recent communication and the interim publication of Choose a Fertility Clinic (CaFC) metrics on 29 May. We acknowledge the challenge of presenting meaningful outcome data in a rapidly evolving clinical landscape, and we appreciate the HFEA's intent to offer patients more timely information.
That said, we must raise serious concerns about the continued use of live birth per embryo transferred as the headline measure.
Focusing on live births per embryo transferred, rather than per cycle started or per patient, omits key aspects of the treatment journey.
This metric can unintentionally:
Favour clinics that selectively transfer only high-quality embryos, often after multiple freeze-all cycles where embryos of average quality are not even given chance and discarded, thereby inflating apparent success rates.
Allow exclusion of patients with poorer prognoses, including those whose cycles are cancelled or result in no embryos for transfer – particularly common in low ovarian reserve.
Create space for clinics to implicitly attribute success to adjunctive treatments or add-ons (such as PGT-A, IVIG, or immune testing), when in fact their reported outcomes benefit from methodological artefacts rather than evidence-based efficacy.
The statement on the HFEA website that differences are due to 'chance' is misleading in this context.
The data being published from highly heterogeneous populations and practices.
Clinics do not all treat the same mix of patients; they can (and do) differ in their:
Patient age profiles.
Use of donor gametes.
Use of PGT-A.
Patient selection (poorer prognosis patients may be shifted into 'natural IVF' category allowing to remove this group of patients from denominator).
Clinical protocols (multiple cycle banking for patients with poor reserve).
Inclusion or exclusion of certain types of cycles in reported denominators.
To suggest that differences of a significant percentage points are simply 'chance' without mentioning that systematic biases in patient selection and reporting drive these differences is non-scientific and risks misleading patients.
The mixing of different subpopulations into one 'success rate' is a serious methodological flaw.
Reporting an aggregate 'live birth per embryo transfer' without appropriate stratification:
Rewards clinics who heavily filter patients pre-transfer.
Hides poor performance in the stimulation, fertilisation, or embryo development phases.
Fails to account for the fact that many patients (especially older or poorer prognosis) never reach embryo transfer.
The current system ignores the fundamental problem of:
Denominator manipulation – by excluding failed cycles and those who never reach embryo transfer, a clinic can appear to outperform others simply by being more selective.
The PGT-A disclaimer is insufficient and misleading.
While the website does mention that PGT-A may influence success rates, the current wording is not enough to prevent patients from perceiving that PGT-A clinics are 'better'.
Critically, it fails to mention that:
Many patients are excluded from reported success rates entirely if their embryos are deemed 'abnormal' and no transfer occurs.
PGT-A outcomes should be reported separately and transparently (as per latest good practice recommendations), with success rates per cycle started or per patient, not just per embryo transfer.
Without full transparency on how many cycles never result in transfer, the success rates can appear artificially high.
We urge the HFEA to consider the following immediate steps.
The presentation of data in current format needs to be suspended.
Live birth rate needs to be reported per cycle started (multiple pregnancy rate still can be assessed in this setting).
Clearly separate PGT-A cycles and donor egg treatments in all outcome data, with transparent labelling by age group.
Aim to develop reporting on cumulative live birth rate per cycle started. While we understand that cumulative live birth rate per cycle started is a more complex metric to present, it remains the internationally accepted gold standard – already adopted by SART/CDC (USA), CARTR+ (Canada), ANZARD (Australia/New Zealand), and endorsed by ICMART. These systems recognise that the patient journey begins with a cycle start, not with an embryo transfer, and that fair reporting must reflect the full scope of that journey.
These concerns are not new. For well over a decade, clinicians and academics have pointed out that current reporting frameworks – including the continued reliance on embryo-based metrics – allow for distortion, selective exclusion, and confusion. Multiple studies and professional commentaries, including from members of our own team, have outlined how such practices undermine the original goals of the HFE Act: to inform, protect, and empower patients. Yet despite these repeated calls, meaningful reform has lagged behind international best practices. With the current update to CaFC, the Authority has a rare opportunity to address long-standing weaknesses and restore confidence in how outcomes are reported and understood.
We also welcome clarity on the upcoming consultation process.
Will clinics, patients, and independent experts be able to contribute formally?
Will the consultation explicitly address the use and abuse of elective freeze-all cycles and multi-cycle commercial packages?
We note that the HFEA's 2025–2028 Strategic Plan includes strong commitments to transparent, patient-centred information and to reducing inequalities in treatment outcomes. We are concerned, however, that the current CaFC metrics – in particular the continued focus on embryo-based success rates – may not fully reflect those strategic priorities in practice. We hope the forthcoming consultation will be an opportunity to bridge this gap and bring CaFC into closer alignment with the Authority's vision.
We believe this is a critical moment. How the HFEA reports outcomes will influence not only patient choice, but also clinical practices and commercial models across the UK fertility sector. Inaccurate or overly simplified metrics carry real risk of harm and perpetuate inequity. Transparent, cycle-based reporting – underpinned by clear definitions and cumulative success data – is essential if CaFC is to become a truly trusted tool for patients.
We thank the Authority for recognising the weight of this responsibility and remain committed to supporting the development of a fairer, more clinically accurate system of reporting.
Professor Dusko ILIC, MD PhD
Professor of Stem Cell Science
King's College London Faculty of Life Sciences and Medicine
School of Life Course and Population Sciences
Department of Women and Children's Health
Person responsible for the HFEA clinical license 0102
Assisted Conception Unit, Guy's and St Thomas' NHS Foundation Trust
Dr Julia Kopeika, MD PhD, FRCOG
Consultant Gynaecologist
Head of Assisted Conception Unit, Guy's and St Thomas' NHS Foundation Trust
Lead For Fertility Preservation
Sub specialist in Reproductive Medicine and Surgery
Professor Yacoub Khalaf, MD, FRCOG
Professor of Reproductive Medicine and Surgery
King's College, London Consultant in Reproductive Medicine and Surgery
Guy's and St Thomas' NHS Foundation Trust Medical Director of the Assisted Conception Unit and Centre for PGD
Tarek El-Toukhy, MSc MD MRCOG
Consultant Gynaecologist
Senior Lecturer, King's College London
Subspecialist in Reproductive Medicine and Surgery
Assisted Conception Unit, Guy's and St Thomas' Hospital NHS Foundation Trust
Professor Caroline Mackie Ogilvie, BSc DPhil OBE
Guy's and St Thomas' NHS Foundation Trust
Professor Ying Cheong, MD, FRCOG
Professor of Reproductive Medicine
University of Southampton
Some of the issues discussed in this open letter will be explored at this year's PET Annual Conference, What Does Genomics Mean for Fertility Treatment?.
#7
General Discussion / Re: Genome sequencing every ne...
Last post by mensfe_admin - 2025-06-23 21:00Films of all six events can be watched below. We believe that you will find them informative, as the UK Government considers rolling out this approach for all newborns. And the team at PET looks forward to holding further public discussions, as this work proceeds.
1. What Should Be Looked For? What Should Be Fed Back?
If you can't see the film embedded above, you can watch it on YouTube.
2. Consenting Adults, Sequencing Babies
If you can't see the film embedded above, you can watch it on YouTube.
3. What Research Can, and Should, Be Done with a Baby's Genome?
If you can't see the film embedded above, you can watch it on YouTube.
4. Genomic Data: A Resource from Cradle to Grave?
If you can't see the film embedded above, you can watch it on YouTube.
5. Workforce Implications for Healthcare Professionals and Beyond
If you can't see the film embedded above, you can watch it on YouTube.
6. Implementing the Generation Study
If you can't see the film embedded above, you can watch it on YouTube.
1. What Should Be Looked For? What Should Be Fed Back?
If you can't see the film embedded above, you can watch it on YouTube.
2. Consenting Adults, Sequencing Babies
If you can't see the film embedded above, you can watch it on YouTube.
3. What Research Can, and Should, Be Done with a Baby's Genome?
If you can't see the film embedded above, you can watch it on YouTube.
4. Genomic Data: A Resource from Cradle to Grave?
If you can't see the film embedded above, you can watch it on YouTube.
5. Workforce Implications for Healthcare Professionals and Beyond
If you can't see the film embedded above, you can watch it on YouTube.
6. Implementing the Generation Study
If you can't see the film embedded above, you can watch it on YouTube.
#8
General Discussion / Genome sequencing every new bo...
Last post by mensfe_admin - 2025-06-23 20:55A Tale of Two Surrogates
Comment
Sequencing the genomes of newborn babies: What led to the UK Government's plans?
by Sarah Norcross
Genomics has been in the headlines in recent days, due to comments made by the UK's health secretary Wes Streeting that were published in the Telegraph. According to that newspaper and other reports, a ten-year health plan is due to be published imminently by the UK Government, and it will include an objective to make whole genome sequencing available for every newborn baby.
Research commissioned by PET (the Progress Educational Trust) in 2022 – conducted by Ipsos – showed that a majority of the UK public at that time (53 percent) supported the idea of whole genome sequencing at birth, as a way of screening for a larger number of rare genetic conditions than the nine that were being screened for by the 'heel *****' test (see BioNews 1148). The same research showed that just ten percent of the UK public were opposed to such an approach.
However, many practical and ethical challenges are involved in sequencing the genomes of newborns. These challenges are currently being investigated by the Generation Study, an NHS-embedded research study which is sequencing the whole genomes of 100,000 newborns. This study, in turn, forms part of the Newborn Genomes Programme (see BioNews 1172), one of several initiatives run by Genomics England.
Since 2014, PET has collaborated with Genomics England to produce public events that explore scientific, ethical and other aspects of whole genome sequencing. Speakers at these events have included experts, practitioners and advocates from a wide variety of backgrounds, including patients and their relatives. Discussion has ranged from lay-accessible explanations of the relevant technology to robust debate about the issues raised.
In recent years, six PET/Genomics England events have focused on the implications of sequencing the whole genomes of newborns. The most recent of these events took place shortly after the announcement that testing of newborns as part of the Generation Study had begun (see BioNews 1259 and 1261), while the preceding five events enabled ideas to be explored and considerations weighed up in public, ahead of the study's launch.
The focus of each event was as follows.
What Should Be Looked For? What Should Be Fed Back?
Consenting Adults, Sequencing Babies
What Research Can, and Should, Be Done with a Baby's Genome?
Genomic Data: A Resource from Cradle to Grave?
Workforce Implications for Healthcare Professionals and Beyond
Implementing the Generation Study
Films of all six events can be watched below. We believe that you will find them informative, as the UK Government considers rolling out this approach for all newborns. And the team at PET looks forward to holding further public discussions, as this work proceeds.
#9
General Discussion / Cumulative live birth rate and...
Last post by mensfe_admin - 2025-05-19 08:05Yaping Jiang†, Lei Jin†, Bo Huang , Li Wu, Xinling Ren, and Hui He
ABSTRACT
STUDY QUESTION: Is early rescue ICSI (E-RICSI) an effective and safe technique compared to conventional ICSI?
SUMMARY ANSWER: Despite the higher multi-pronucleus (PN) rate compared to conventional ICSI, E-RICSI did not add extra risks to clinical and neonatal outcomes.
WHAT IS KNOWN ALREADY: Based on the finding that the second polar body was released in 80% of fertilised oocytes by 4h after exposure to spermatozoa and in 90% of fertilised oocytes by 6h, E-RICSI brings forward the timing of rescue ICSI to 6h after initial insemination and effectively prevents oocyte ageing and embryo-uterus asynchrony. However, some researchers still voice concerns about the efficacy and safety of E-RICSI, and comparative studies are limited.
STUDY DESIGN, SIZE, DURATION: A retrospective cohort study was conducted on patients who underwent conventional ICSI or E-RICSI treatment between January 2015 and December 2020 at a university-affiliated hospital. Using 1:1 propensity score matching, 1496 cases entered each group.
PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 1496 couples undergoing conventional ICSI oocyte retrieval cycles and 1496 undergoing E-RICSI oocyte retrieval cycles were enrolled in this study, and basic clinical characteristics, embryologic data, clinical outcomes and neonatal data were compared between groups. The embryos in the E-RICSI group were divided into two subgroups: those fertilised by IVF (IVF subgroup) and those fertilised by E-RICSI (E-RICSI subgroup). The embryologic data, clinical outcomes, and neonatal data for these subgroups were also compared with those of the conventional ICSI group. Logistic regression was used for statistical analysis with potential confounder adjustment.
MAIN RESULTS AND THE ROLE OF CHANCE: The 2PN rate, blastocyst formation rate, and viable blastocyst formation rate of the E-RICSI group were significantly lower compared to the conventional ICSI group (2PN rate: P<0.001; blastocyst formation rate: P<0.001; viable blastocyst formation rate: P¼0.004), and the multi-PN rate in the E-RICSI group was significantly higher than the conventional ICSI group (P<0.001). However, the numbers of 2pn embryos, normal cleavage embryo rates, Day 3 high-quality cleavage embryo rates, and high-quality blastocyst rates were similar between groups. When considering the IVF embryos and E-RCSI embryos in the E-RICSI group independently, the 2PN rate of the conventional ICSI group was significantly lower than E-RICSI subgroup but higher than the IVF subgroup, whereas the blastocyst formation rate and viable blastocyst formation rate were higher than E-RICSI embryos but comparable to IVF embryos. Regarding the clinical and neonatal outcomes, the implantation rate in the E-RICSI subgroup was significantly lower than in the IVF subgroup but comparable to that in the conventional ICSI group. Conversely, the low birthweight (LBW) rate was significantly lower compared with the conventional ICSI group but similar to that in the IVF subgroup. No other differences were observed among the three groups for cumulative clinical pregnancy rate, cumulative live birth rate, and the pregnancy outcomes per transfer, including clinical pregnancy, ectopic pregnancy, miscarriage, and live birth, either in fresh or frozen embryo transfer cycles. Furthermore, neonatal outcomes, including cesarean section, sex ratio, LBW, preterm birth, and macrosomia, were similar among groups.
LIMITATIONS, REASONS FOR CAUTION: This study is limited by the retrospective design, limited sample size, and short follow-up period. However, our study underlies the need for large-scale, multi-center randomized controlled trials with long-term follow-up.
WIDER IMPLICATIONS OF THE FINDINGS: Short-term insemination (3h) combined with E-RICSI may be a safe and effective method to prevent the occurrence of total fertilisation failure, and patients with normal or borderline sperm could be encouraged to try IVF first.
ABSTRACT
STUDY QUESTION: Is early rescue ICSI (E-RICSI) an effective and safe technique compared to conventional ICSI?
SUMMARY ANSWER: Despite the higher multi-pronucleus (PN) rate compared to conventional ICSI, E-RICSI did not add extra risks to clinical and neonatal outcomes.
WHAT IS KNOWN ALREADY: Based on the finding that the second polar body was released in 80% of fertilised oocytes by 4h after exposure to spermatozoa and in 90% of fertilised oocytes by 6h, E-RICSI brings forward the timing of rescue ICSI to 6h after initial insemination and effectively prevents oocyte ageing and embryo-uterus asynchrony. However, some researchers still voice concerns about the efficacy and safety of E-RICSI, and comparative studies are limited.
STUDY DESIGN, SIZE, DURATION: A retrospective cohort study was conducted on patients who underwent conventional ICSI or E-RICSI treatment between January 2015 and December 2020 at a university-affiliated hospital. Using 1:1 propensity score matching, 1496 cases entered each group.
PARTICIPANTS/MATERIALS, SETTING, METHODS: In total, 1496 couples undergoing conventional ICSI oocyte retrieval cycles and 1496 undergoing E-RICSI oocyte retrieval cycles were enrolled in this study, and basic clinical characteristics, embryologic data, clinical outcomes and neonatal data were compared between groups. The embryos in the E-RICSI group were divided into two subgroups: those fertilised by IVF (IVF subgroup) and those fertilised by E-RICSI (E-RICSI subgroup). The embryologic data, clinical outcomes, and neonatal data for these subgroups were also compared with those of the conventional ICSI group. Logistic regression was used for statistical analysis with potential confounder adjustment.
MAIN RESULTS AND THE ROLE OF CHANCE: The 2PN rate, blastocyst formation rate, and viable blastocyst formation rate of the E-RICSI group were significantly lower compared to the conventional ICSI group (2PN rate: P<0.001; blastocyst formation rate: P<0.001; viable blastocyst formation rate: P¼0.004), and the multi-PN rate in the E-RICSI group was significantly higher than the conventional ICSI group (P<0.001). However, the numbers of 2pn embryos, normal cleavage embryo rates, Day 3 high-quality cleavage embryo rates, and high-quality blastocyst rates were similar between groups. When considering the IVF embryos and E-RCSI embryos in the E-RICSI group independently, the 2PN rate of the conventional ICSI group was significantly lower than E-RICSI subgroup but higher than the IVF subgroup, whereas the blastocyst formation rate and viable blastocyst formation rate were higher than E-RICSI embryos but comparable to IVF embryos. Regarding the clinical and neonatal outcomes, the implantation rate in the E-RICSI subgroup was significantly lower than in the IVF subgroup but comparable to that in the conventional ICSI group. Conversely, the low birthweight (LBW) rate was significantly lower compared with the conventional ICSI group but similar to that in the IVF subgroup. No other differences were observed among the three groups for cumulative clinical pregnancy rate, cumulative live birth rate, and the pregnancy outcomes per transfer, including clinical pregnancy, ectopic pregnancy, miscarriage, and live birth, either in fresh or frozen embryo transfer cycles. Furthermore, neonatal outcomes, including cesarean section, sex ratio, LBW, preterm birth, and macrosomia, were similar among groups.
LIMITATIONS, REASONS FOR CAUTION: This study is limited by the retrospective design, limited sample size, and short follow-up period. However, our study underlies the need for large-scale, multi-center randomized controlled trials with long-term follow-up.
WIDER IMPLICATIONS OF THE FINDINGS: Short-term insemination (3h) combined with E-RICSI may be a safe and effective method to prevent the occurrence of total fertilisation failure, and patients with normal or borderline sperm could be encouraged to try IVF first.
#10
General Discussion / Epigenetic differences identif...
Last post by mensfe_admin - 2025-05-13 08:06by Dr Marisa Flook
Methylation in the placentas of male and female fetuses has marked differences, according to a study by researchers at the National Institutes of Health, Bethesda, Maryland.
DNA methylation is an epigenetic mechanism that cells use to control gene expression. It occurs when a tag known as a methyl group is added to the DNA molecule without altering its underlying sequence. The addition of this tag allows the regulation of gene expression by turning genes 'on' or 'off'. Using multi-omics techniques, to determine the precise molecular changes which define cell types and their development, the researchers analysed the methylation patterns of 152 male and 149 female placental samples from a larger study. The placenta develops from cells that are part of the early embryo, and the researchers have identified differences between male and female placentas that may play a role in birthweight and adult diseases.
Publishing their findings in Nature Communications the authors wrote: 'This study offered several unique insights about the landscape of sex differences in the level and genetic regulation of methylation and gene expression in the human placenta... [The] findings suggest the potential role of placenta-mediated sex differences in developmental and later-life physiological traits and diseases.'
The researchers identified 6077 DNA sites with different methylation patterns between males and females, of which 2497 were previously unreported. Overall, 66.9 percent had higher methylation in DNA from male placentas, which were linked with greater neonatal size. The remaining 33.1 percent had higher methylation in DNA from female placentas and were linked to greater placental size.
Some increases in methylation were sex specific, such as DNA sites near the CCDC6 gene in males and the NIRF1 gene in females. Reduced expression of these genes has been previously linked to preterm deliveries and preeclampsia, respectively.
The authors found that higher methylation near the FNDC5 gene was associated with lower expression of the gene in male placentas but not in female placentas. FNDC5 is involved in the production of irisin, which protects the placenta from damage by reactive oxygen molecules and insulin resistance. Lower irisin levels have been associated with preeclampsia and lower placental weight.
Additionally, the researchers identified variations in the ATP5MG and FAM83A genes expressed in the female placenta that have been associated with asthma, hay fever, eczema and breast cancer.
The authors noted that their study was unable to distinguish sex differences that emerged in early gestation from those that emerged in later gestation. For example, a previous methylation study on first trimester placentas found that ZNF300 was highly methylated in male but not female placentas (see BioNews 1262), which was similarly observed in the present study.
Dysfunction of the placenta underlies many pregnancy complications and is thought to determine male and female health differences that occur later in life. The differences in DNA methylation uncovered in this study could support future research on the higher risk for pregnancy complications involving male fetuses, such as stillbirth and prematurity.
Temperature controls mechanism in sperm linked to male fertility
by Dr Coco Newton
The mobility of sperm appears to be temperature-dependent due to the action of a single protein, according to research carried out in mice.
Researchers from Washington University School of Medicine, St Louis, Missouri used techniques originally developed to study brain cells to show that electrical discharges from a particular sperm protein, CatSper, increased when the temperature surrounding the cell surpassed 38 degrees Celsius. In parallel, sperm behaviour switched from a smooth swim-like motion used for navigation to hyperactive propellor movements needed for entry into the egg.
'That hyperactive state in sperm is key for successful fertilisation, and no one knew exactly how temperature triggers it,' said professor of cell biology and physiology Polina Lishko, corresponding author of the paper published in the journal Nature Communications.
Previous research suggested sperm mobility changes may be activated by environment pH or reproductive hormones like progesterone (see BioNews 1078, 1102 and 1121).
While the study was done in mice, the CatSper protein is common to all mammals, and previous research has linked mutations in the CatSper gene to human male infertility. The protein regulates calcium ion entry into sperm cells, thereby controlling the sperm tail motion.
Because most mammals – including humans – create and store sperm in testes around two to four degrees lower than the body temperature, the researchers hypothesised that reaching the warmer internal female reproductive tract might activate CatSper.
Professor Lishko suggested the findings may offer new approaches to male contraception and infertility treatments, with previous attempts to target the protein proving unsuccessful: 'Instead of creating inhibitors, it might be possible to activate CatSper with temperature, thus prematurely switching on this channel to drain the sperm of energy, so that by the time the sperm cell is ready to do its job and enter the egg cell, it is powerless.'
The study also revealed that the pH of the testes and an additional ejaculate molecule, spermine, both appear to shield CatSper from warmer temperatures to prevent sperm activating before reaching the egg.
The authors drew on evolutionary observations that species without the CatSper proteins, such as birds, have internal testes where temperature-activation is redundant. They also highlighted that men with varicocele – an overgrowth of blood vessels leading to increased testicular temperature – show impaired sperm motility which can lead to infertility. However, whether CatSper is the mechanism by which variocele affects fertility remains unknown