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The HFEA's monthly newsletter for clinic staff

July 2025

HFEA comments on the news that eight babies have been born after mitochondrial donation treatment

The HFEA welcomes the publication of two papers in the New England Journal of Medicine earlier this month which details that eight babies have now been born through this pioneering IVF technique that reduces the risk of mitochondrial diseases.

 

Legislation regarding mitochondrial donation was originally passed in 2015 with the The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations, with the treatment licensed and regulated by the HFEA. 

 

Further comment can be found here.

 

Choose a Fertility Clinic (CaFC) update – upcoming consultation

In the summer we will be running a consultation to gather views on which CaFC homepage statistics are most helpful for the public and representative of fertility treatment today.

 

This focused consultation will be open to both patients and professionals, and a link to participate will be shared via Clinic Focus and our social media channels.

 

Competition and Markets Authority (CMA) report published

On 18 July the CMA published a short report summarising its work to explore a voluntary initiative aimed at giving fertility patients more helpful price information when they are comparing clinics and choosing where to have treatment.

 

The update explains that the CMA concluded that a voluntary approach along the lines proposed is not the way forward and sets out the reasons why. 

 

The report also:

  • provides some further detail on what the CMA considers clinics need to do to ensure they comply with their consumer law obligations when providing price information to patients
  • aims to help clinics by providing an overview of recent changes to the law introduced by government as part of the Digital Markets, Competition and Consumers Act 2024 (DMCC Act)., which came into force on 6 April 2025
  • encourages clinics to consider responding to the CMA’s consultation on draft cross-sectoral guidance on the new price transparency rules that came in as part of the DMCC Act. The consultation closes on 8 September 2025. 

The CMA has also written to the government to share the report and reiterate its view that patients would benefit from the HFEA being given a more flexible range of regulatory tools.

 

Regulation of Artificial Intelligence in fertility treatment: New Clinic Portal page launched 

As part of our increased strategic focus on artificial intelligence, robotics and automation in fertility treatment, we have launched a new page on the Clinic Portal to signpost clinics to information relevant to the safe adoption of these technologies.

 

This follows a previous Clinic Focus article in which we highlighted guidance in the HFEA’s Code of Practice that should be referred to for how activities and processes carried out in the course of providing treatment services, including those using AI, robotics and automation, can be used and offered in clinics responsibly. Clinics should ensure that they are using the appropriately CE marked medical devices and have validated the equipment using an appropriately qualified individual or company.

 

Medical devices on the UK market (including Software as a medical device and AI as a medical device) are regulated under the UK’s Medical Devices Regulations 2002 (as amended), falling within the remit of the Medical and Healthcare products Regulatory Agency (MHRA). For detailed guidance, updates, and queries on the regulation on AI as a Medical Device, clinics should refer to the MHRA directly.

 

With our Scientific and Clinical Advances Advisory Committee (SCAAC), we will continue to review developments in the uses of AI within fertility treatment, and this topic was last discussed at their February 2024 SCAAC meeting. 

 

This new webpage will be updated with relevant information as it becomes available. 

 

Authority meeting: 9 July 2025

The latest Authority meeting took place on 9 July 2025.

 

The Register Research Panel (RRP) annual report was presented to Authority, including an overview of research engagements activities undertaken and data research reports published in 2024/5. 

 

The Authority also discussed the upcoming Choose a Fertility Clinic (CaFC) focused consultation, which will seek views on the headline metrics to be used for the ‘full’ CaFC publication.

 

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

 

Updates from the Scientific and Clinical Advances Advisory Committee – June 2025

The Scientific and Clinical Advances Advisory Committee (SCAAC) met on 9 June 2025. Papers from the meeting are available on the SCAAC webpage. 

 

The Committee discussed developments in the following horizon scanning topics and considered an application to add platelet-rich plasma to the HFEA’s treatment add-on’s rated list: 

 

Health outcomes for ART patients (including gestational surrogates and egg donors)

 

The committee discussed research findings related to risk factors associated with different types of ART, including treatment using donated gametes, egg donation, and undergoing ART as a surrogate. The Committee was joined by external expert Professor Alastair Sutcliffe from University College London. The committee recommended that information on the HFEA website relating to donation, surrogacy and pre-conception health be reviewed and where necessary updated in line with the research discussed.

 

Impact of the microbiome on fertility and fertility treatment outcomes

 

Members reviewed research developments, including research on both the male and female reproductive tract microbiome and infertility, alongside relevant research on the gut microbiome, and interventions targeted to improve fertility treatment outcomes. In light of microbiome testing increasingly being offered as an adjunct to fertility treatment, members that these tests should be considered as treatment add-ons.

 

In order for microbiome and other pre-treatment testing to meet to the definition of an add-on, the HFEA Authority (board) expanded the definition of a treatment add-on during their July Authority meeting. The evidence base underlying microbiome testing will be evaluated for a rating at a subsequent SCAAC meeting.
 

Platelet-rich plasma as a treatment add-on

 

The Committee considered an application to add platelet-rich plasma (PRP) for intrauterine and intraovarian infusion/injection to our rated treatment add-on list. Given there is limited evidence regarding the effectiveness and risks of these treatments, the SCAAC members considered that both intrauterine and intraovarian PRP treatment met the criteria eligible for an HFEA treatment add-on .

 

Intrauterine and intraovarian PRP treatments will be brought back to a subsequent meeting of the SCAAC for a rating to be assigned. Further information on introducing a treatment add-on to the HFEA rated list, can be found on this webpage.

 

Relevant public health developments and research findings

 

Members considered two recent papers on the use of intracytoplasmic sperm injection (ICSI) in patients without severe male factor infertility, including the recent randomised clinical trial by Berntsen et al. (2025). As highlighted on the HFEA webpage, good practice guidelines published by the British Fertility Society and recommendations published by the European Society of Human Reproductive Medicine do not recommend using ICSI over standard IVF treatment in these circumstances.  

 

In addition, the SCAAC discussed the recent guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) considering the use of GLP-1. Licenced centres will have received an email from the HFEA Alerts mailbox about this on 5 June 2025. To ensure that patients are aware of this guidance, the committee recommended that patient-facing information on the use of these medicines when trying to conceive is made available via the HFEA . This will reflect the guidance issued by the MHRA, and once live on the HFEA website we will share a link to the information in a future Clinic Focus edition.

 

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

 

HFEA’s Annual Horizon Scanning Meeting 2025

Each year the HFEA hold a Horizon Scanning Meeting during the European Society of Human Reproduction and Embryology (ESHRE) conference, bringing together international experts and regulatory bodies to discuss the latest developments in fertility treatment and human embryo research.

 

This year attendees discussed developments relevant to the future use of mitochondrial donation beyond preventing inherited disease, in vitro spermatogenesis in male fertility preservation, and the potential of robotics and automation to revolutionise fertility treatment.

 

Insights gained during this meeting will inform the ongoing work of our Scientific and Clinical Advances Advisory Committee as they consider the new techniques and treatments on the horizon for assisted reproduction.

 

Reporting rescue ICSIs through PRISM

Please note there is new guidance on the PRISM Homepage on how to report Rescue ICSIs (Intracytoplasmic sperm injection).

 

PRISM users should refer to the PRISM homepage message board for further information, and clinics using API solutions should contact their respective system supplier helpdesks.

 

Alert reminder

  • Alert 2025/09 - Class 3 Medicines Recall: Wockhardt UK Ltd Tamoxifen 20mg Film-Coated Tablets, precautionary recall

Alert 2025/09 was issued on 1 July 2025

 

If the PR at your clinic did not receive this alert via email, please contact Business Support at HFEACompliance@HFEA.gov.uk to update your contact details. Please also make sure that the email address alerts are sent from, alert@hfea.gov.uk, has been whitelisted by your IT department.

 

If there are members of clinic staff, other than your PR, who would also like to receive alerts, then please provide Business Support with their details, using the email address above.  

 

The Medicines and Healthcare products Regulatory Agency (MHRA) publish all Field Safety Notices (FSNs) on their website. 

 

For any questions about the content of the Alerts, please contact incident.reporting@hfea.gov.uk.

 

 

Did you know?

Alternate text

Clinics can give patients the option to take unused embryos out of the clinic so they can hold their own ritual or ceremony for these embryos.

 

The Code of Practice states at 15.3: ‘15.13 The centre should take account of the special status of the human embryo when the development of an embryo is to be brought to an end. Terminating the development of embryos and disposing of the remaining material should be approached with appropriate sensitivity, having regard to the interests of the gamete providers and anyone for whose treatment the embryos were being kept’.

 

The 1990 Act regulates “live” human embryos and requires that proper arrangements are made for the keeping and disposal of embryos or human admixed embryos that have been removed from storage. The Act also requires the ability to trace any embryos during any step from procurement to use for human application or disposal. If embryos are no longer “live” they are not regulated by the 1990 Act prohibitions. However, it is a condition of every storage licence (as required by section 14 of the 1990 Act) that embryos that have been kept in storage pursuant to a licence must, once they may no longer be lawfully so kept, be removed from storage and disposed of.

 

The clinic should conduct a risk assessment (approved by the Person Responsible) to determine the fate of all stored material if a new procedure for appropriate disposal of gametes and embryos is introduced. The clinic should validate the method for disposal such as the method used to lyse the embryos, so they are ‘no longer live’. This should ensure that the practice is consistent with requirements under the Act, including proper arrangements and traceability of embryos until disposal. It will also need to ensure that the proposed approach complies with any other relevant legislation/best practice including guidance on the safe management of clinical waste.

 
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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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