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The HFEA's monthly newsletter for clinic staff

February 2025

Updates from the Scientific and Clinical Advances Advisory Committee (SCAAC) – February 2025

The Scientific and Clinical Advances Advisory Committee (SCAAC) met on 3 February 2025. Papers from the meeting are available on the SCAAC webpage.

The Committee discussed developments in the following horizon scanning topics and allocated a rating to androgen supplementation as a treatment add-on:

Health outcomes in children conceived by Assisted Reproductive Technology (ART)

A paper summarising research developments in health outcomes in children born from ART (including the impact of culture media) was presented to the Committee for discussion. Members discussed the challenges of studying the impact of culture media, the limitations of linkage studies, and use of HFEA Register data. It was agreed that health outcomes for ART patients (including gestational surrogates and egg donors) should become a separate SCAAC horizon scanning topic.

Impact of stress on fertility treatment outcomes

Members considered research developments on stress and its associations with fertility treatment outcomes, including stress as a factor in the decision to discontinue fertility treatment. It was agreed that, while treatment may be stressful for patients, measurements of stress are heterogeneous making the relationship between stress and treatment outcomes difficult to determine. Outcomes aside, patients should be encouraged to seek interventions that reduce stress due to the likely positive impact on their stress levels and emotional wellbeing.

Mitochondrial donation: polar body transfer

Mitochondrial donation was brought back to the Committee to discuss research on the technique of polar body transfer, published since the last review in November 2016. Polar body transfer is currently unlawful in treatment in the UK. Members agreed that, despite the promise of lowering the risk of carryover of affected mitochondria, research is still experimental and not yet sufficient to make a strong case for further review or legislative change.

Androgen supplementation as a treatment add-on

During the June 2024 SCAAC meeting, the Committee advised that androgen supplementation met the criteria to be eligible for an HFEA treatment add-on rating. The Committee subsequently rated both dehydroepiandrosterone (DHEA) and testosterone for use by most fertility patients, older women, and women with poor/diminished ovarian reserve. Further information will be added to the ‘Treatment add-ons with limited evidence’ webpage in due course.

In addition, the SCAAC reviewed the prioritisation of their horizon scanning topics and agreed their workplan for 2025/26. Research developments in the topics of ‘Reproductive organoids’ and ‘Health outcomes for ART patients (including gestational surrogates and egg donors)’ will now be considered through the SCAAC’s horizon scanning function.

Once approved, minutes from the meeting will be available on the SCAAC webpage.

HFEA’s Scientific Committee is recruiting two new External Advisors

We are currently recruiting for two new External Advisors to join the Scientific and Clinical Advances Advisory Committee (SCAAC) from June 2025.

The SCAAC, a subcommittee of the Authority, meets three times a year to consider advances in science and clinical practice which are relevant to the Authority’s work.

The HFEA is looking to appoint two new External Advisors to the SCAAC with the following areas of expertise:

Andrology and urology with a focus on male infertility
Artificial intelligence, machine learning and big data in fertility treatment OR automation and robotics in fertility treatment OR biostatistics and assessing the quality of research in fertility treatment

External Advisors are appointed to the SCAAC for a term of three years, with a maximum of two terms. A fee of £325 per day is paid to External Advisors for their attendance and contribution to committee meetings. Travel and expenses incurred for attending in-person meetings will also be covered.

To find out more about the External Advisor vacancies, please click here. The deadline for applications is Sunday 16 March 2025.

More information about the SCAAC can be found here.

Update from the Advertising Standards Authority (ASA) on good level of compliance with the joint ASA/HFEA enforcement notice

The ASA and HFEA issued a joint enforcement notice in 2021 to ensure fertility clinics and others were aware of the advertising rules and treating consumers fairly. The enforcement notice provides further guidance and remains in place. The ASA periodically review compliance with their rules and recently carried out a review in the fertility sector.

In their most recent review, the ASA initially found around 3,000 paid for adverts from just under 60 UK clinics, mostly on Google but also on Meta (Instagram and Facebook). Of these, they pinpointed 900 of interest and after reviewing them further looked at about 300 around claims of efficacy or superiority (in terms of treatment or success rates). This resulted in the ASA contacting a small number of clinics where they had concerns, who all responded positively to them.

The ASA were very pleased to see much less in terms of absolute claims than they had previously and that the level of compliance with the enforcement notice by UK clinics is very good. They will continue to review compliance by UK clinics on an annual basis.

Authority meeting: 22 January 2025

The latest Authority meeting took place on 22 January 2025. Papers were presented to the Authority on two areas of law reform; ‘stem cell-based embryo models (SCBEMs)’ and ‘in vitro gametes (IVGs)’.

Members were also asked to approve our strategy for 2025-28, following comments on the draft strategy presented at the November Authority meeting.

Stem cell-based embryo models: The paper provided background, including the international and UK regulatory and governance landscape, and SCAAC consideration of SCBEMs.

The Authority were asked to consider whether there is a case for recommending that SCBEMs are subject to some form of statutory regulation, and whether SCBEMs should be regulated on their own terms or as “live human embryos”. They also discussed whether to make it explicit that SCBEMs cannot be transferred to a human, and whether to introduce a fixed upper limit on embryo model culture time.

IVGs: The paper presented a summary of SCAAC consideration of IVGs, provided an overview of international context and public opinion, and looked at potential benefits and drawbacks of IVG use in research and clinical settings.

The Authority were asked to consider a number of points, including whether there is a case for recommending that IVGs are subject to some form of statutory regulation - and whether it is necessary to make it explicit that IVGs cannot currently be transferred to a human.

You can find minutes and papers for previous and upcoming Authority meetings here and watch the meetings on YouTube here.

Reminder: advertising rules for recruiting egg and sperm donors

We would like to remind clinics of their responsibilities when recruiting gamete donors. Adverts aimed at recruiting donors should not refer to the possibility of financial gain.

Any advertising should be carried out in line with the Advertising Standards Authority (ASA) codes, the joint ASA/HFEA enforcement notice for the fertility sector and information provision set out in our Code of Practice.

These advertising rules also apply to online services that aim to recruit donors.

 The HFEA  Code of Practice sets out:

“13.1 Advertising or publicity aimed at recruiting gamete or embryo donors, or at encouraging donation, should not refer to the possibility of financial gain or similar advantage, although it may refer to compensation permitted under relevant HFEA Directions.”

Additionally, section 11.1 of the Code states that advertising and publicity materials “should be designed and written with regard to the sensitive issues involved in recruiting donors”.

Donor compensation in the UK is intended to remove any unjustifiable barriers to donation and is based on the principle that donation is an altruistic act.

Free and impartial information about egg donation and sperm donation can be found on our website – including our egg donation fact sheet.

Prevention of OHSS – updated guideline

The British Fertility Society (BFS) has recently published the ‘Prevention of ovarian hyperstimulation syndrome (OHSS): British Fertility Society policy and practice guideline (2025).’

The guideline aims to support clinicians in preventing ovarian hyperstimulation syndrome (OHSS) in patients undergoing gonadotropin ovarian stimulation. It has been produced as an aid to good clinical practice and clinical decision-making.

The guideline can be found here.

Care Quality Commission (CQC) and HFEA update joint working principles

The Memorandum of Understanding (MoU) between the CQC and HFEA has been revised as part of a regular review process.

It sets out the framework to support the working relationship between the CQC and the HFEA to safeguard the wellbeing of the public receiving health and social care services in England. It relates only to the regulation of healthcare.

You can read the revised MoU between the Care Quality Commission and the HFEA here.

Did you know?

Patient complaints

In 2021 the Parliamentary and Health Service Ombudsman introduced the NHS Complaint Standards, explaining how organisations providing NHS services should approach complaint handling.

The standards apply to NHS organisations in England and independent healthcare providers that deliver NHS-funded care - the information and toolkit can also be utilised by non-NHS centres.

The Standards give organisations the tools and guidance to provide a more effective, streamlined complaint handling service. They also make it easier to capture and act on the learning that prevents mistakes happening again and improves services.

They have a strong focus on:

early resolution by empowered and well-trained people
all staff, particularly senior staff, regularly reviewing what learning can be taken from complaints
how all staff, particularly senior staff, should use this learning to improve services

The Complaint Standards are based on ‘My Expectations’ which sets out what patients want to happen when they make a complaint about health or social care services. The Standards and the guidance modules describe how staff can meet those expectations. Further information can be found in the reports below:

Editorial statement

Clinic Focus is the official electronic newsletter of the Human Fertilisation and Embryology Authority, is produced by the editorial team of the HFEA and provides a monthly roundup of news and information for clinics and their staff working in the field of fertility treatment.

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