The HFEA's monthly newsletter for clinic staff |
| |
|
HFEA Choose a Fertility Clinic (CaFC) - full CaFC publication statistics |
The HFEA has now decided which main profile page statistics we will be using when we publish the full CaFC later this year. This is further to the updates in the June, July, August, and September editions of Clinic Focus, and after a focused consultation, which ran over the summer, asking for views from professionals and patients on the main profile page statistics for each licensed clinic.
The Authority met on 5 November to discuss the findings and made several decisions outlined below. The full Authority papers can be read here, and a recording of the meeting is available to view here.
The Authority decided: -
That the main profile page statistics to be published will be ‘births per egg collection procedure’ (including PGT-A cycles) and ‘births per embryo transferred’ (excluding PGT-A cycles). Both metrics will include fresh and frozen transfers, but will exclude treatments using donor eggs. Births per egg collection procedure (cumulative rate) is calculated using the number of “birth events” (meaning twin or triplet births would only be counted once) divided by the number of egg collections, shown as a percentage. This is calculated using egg collections over a 12-month period and includes any outcomes from those egg collections over a period of two years.
- Clinics who do not meet the full CaFC publication deadline this year, no data will be shown - any old data will be removed and there will an explanation for why there is no data for that clinic. A clinic can ‘rejoin’ CaFC once it has signed off the appropriate data.
- That the heading “IVF Birth Rate” at the top of each clinic’s page will be removed and we will not reinstate a symbol to signify whether a clinic is ‘in line with national average’.
-
That a sub-group of Authority members will decide on methodological questions - Kevin Hudson has contacted clinic PRs directly about this. Further information on methodology is also available on the Clinic Portal.
Next steps:
We are planning that, by the end of 2025, CaFC will be updated with data to the end of 2023 (births) and 2024 (pregnancies), with the agreed headline statistics - ‘births per egg collection procedure’ and ‘births per embryo transferred’ - shown on each clinic’s main profile page. For accuracy it’s important that births are reported to us by all clinics in a timely manner, as ‘births per egg collection procedure’ is cumulative over 24 months. For any queries relating to CaFC data or the methodologies used, please contact PRISMsupport@hfea.gov.uk. |
FAQs relating to incorrect donor information |
We are aware of a small number of historic cases where the information released from our Register has not matched the information that donor conceived people have received from DNA matching services. This may be because we have received incorrect information to our Register from the treating clinic. You can read our FAQs relating to incorrect donor information here.
You can also read our statement on this here. |
‘The Fertility Sector 2024/25’ report published |
We recently published our ‘The Fertility Sector 2024/25’ report (formerly State of the Sector).
The report provides a snapshot of the HFEA’s regulatory work for the year, covering the number of inspections, reported incidents and non-compliances. Our data shows that more than 100,000 fertility treatment cycles took place in UK licensed clinics last year, with incidents occurring in less than 1% of them. Other key findings from the report include:
The number of inspections decreased from 104 in 2023/24 to 88 in 2024/25, due to licence length changes that occurred during the COVID-19 pandemic, as well as six additional inspections.
The number of non-compliances identified during inspections decreased from 226 to 131. This will relate in large part to the lower number of inspections carried out compared to the previous year. Across all clinics, however, the average number of non-compliances was 1.5 per inspection carried out.
There were 792 incidents reported to the HFEA in 2024/25, 36% more than the 581 incidents reported in 2023/24. In 2024/25, UK licensed clinics reported 67 cases of severe and critical OHSS.
The total number of clinics licensed by the HFEA in 2024/25 was 141, an increase of six since 2023/24. Of these, 107 are licensed to provide fertility treatment with the remainder licensed to store gametes and embryos, or for research.
You can read the full report here. |
|
|
House of Commons Committee launches new inquiry into egg donation and freezing |
The House of Commons Women and Equalities Committee (WEC) launched a new inquiry into egg and embryo donation and freezing on 13 November. The committee will examine whether women donating and freezing their eggs do so with sufficient information about the process, health impacts and consequences.
The inquiry will also consider whether the current regulatory framework has adequate safeguards to protect individuals from exploitative practices and whether enough is known about the effects of undergoing these procedures.
Further details on this inquiry can be found here. The deadline for submitting evidence is 9 January 2026 and clinics and professional bodies, as well as individuals, can give evidence. |
PR event 2026 - save the date |
PRs of treatment and storage centres will have received a save the date to attend our PR event for 2026, which will be held on 30 April 2026 in person at the HFEA office in Stratford, East London. The event will be a fantastic opportunity for PRs to come together with the HFEA to discuss issues relating to fertility treatment and how the fertility sector is regulated.
Please note, this event is for PRs only and we would strongly encourage all PRs to attend. Please save the date in your diary and a formal registration form will be sent over in the next couple of weeks for you to complete. |
Authority meeting: 19 November 2025 |
The latest Authority meeting took place on 19 November 2025. Members were presented with a summary of the HFEA’s most recent publication, ‘The Fertility Sector Report’, and a review of inspection feedback.
A paper was also presented to the Authority on the ‘Regulation of Artificial Intelligence in Fertility Treatment’, with members asked to decide whether the HFEA should take steps to develop our regulatory stance now or respond as needed (regarding further patient information, stakeholder engagement, or work on regulatory expectations). Members were asked to consider a number of points, including the current and emerging AI applications in fertility treatment, the HFEA’s regulatory framework and its current limitations.
You can find minutes and papers for previous and upcoming Authority meetings here and watch the meetings on YouTube here. |
|
|
-
Alert 2025/11 - Field Safety Notice: Rocialle Healthcare Limited, RML130-001(200) Specimen Container 30ml double wrapped, product may not be sterile
Alert 2025/11 was issued on 7 November 2025 - Alert 2025/12 - Field Safety Notice: GE HealthCare BK Medical ApS: Ultrasound system type 2300, 1300, 1202, insufficient guidance relating to battery use
Alert 2025/12 was issued on 25 November 2025 -
Alert 2025/13 - Field Safety Notice: Philips Ultrasound Lumify Systems, incompatible with iOS 18 devices
Alert 2025/13 was issued on 25 November 2025
If the PR at your clinic did not receive these alerts 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. |
|
|
Licensed clinics have access to the Clinic Portal through an individualised username and password. This allows access to clinic specific data, including PRISM patient data, either as part of the data submission process, or to assess PRISM errors.
Access is initially given to the clinic Person Responsible (PR), who is then able to provide access to their staff. PRs can also revoke usernames and passwords, for example when a staff members’ employment ends (in which case these details must not be given to another individual), or if their job role no longer requires access to the data held within the Clinic Portal. PRs are also able to provide ‘UserAdmin’ permission level to appropriate staff members to aid in the creation and maintenance of user accounts within the Clinic Portal. It is important to remember that usernames and passwords are confidential and should never be shared or used by anyone other than the person owning the credentials. PRs must not allow other users access to their username or password, nor to submit applications through the Clinic Portal. It is permissible for other staff to generate and complete draft applications for the clinic, however the PR must always review, sign (by ticking the box) and submit all applications.
If a member of clinic staff does not have a username/password and believes they should, they should first discuss this with their clinic’s PR. For clinic staff who have credentials but are experiencing problems logging onto the Clinic Portal these should be escalated to the Portal support team via portalsupport@hfea.gov.uk.
PRs are reminded that they are responsible for ensuring and maintaining confidentiality and compliance with relevant data protection and GDPR requirements within their clinic. Standard Licence Conditions T9, T43, T44 and T45 |
|
|
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. No part of this publication may be reproduced without prior permission. You can view our privacy policy on our website. Click here to unsubscribe 2 Redman Place London E20 1JQ © Copyright Human Fertilisation and Embryology Authority, 2019 |
|
|
|