Having problems viewing this email? View in browser

The HFEA's monthly newsletter for clinic staff

February 2024

Requests for the date of birth of egg donors from midwives

We are aware of situations where during ante-natal care midwives have requested that clinics or patients provide the date of birth of an egg donor, following successful conception using a donor egg. Clinics are reminded of their responsibility to protect the identity of donors and we offer some guidance on how to respond to these requests.

Clinics have an obligation to withhold any information which might identify a donor. Only those conceived as a result of donation can access identifying information about their donor and they can only do so once they reach the age of 18.

On occasion, midwives request the date of birth of the egg donor as part of the screening process for Down's syndrome, Edwards' syndrome and Patau's syndrome during pregnancy. Whilst it is a question for the PR to decide how they wish to respond to such requests, releasing the date of birth of a donor is not something the HFEA would encourage without first giving careful consideration to the legal basis for any disclosure, and a clear explanation of why the date of birth is required rather than simply the year of birth or age of the donor. As set out in paragraph 20.1 of the Code of Practice:

“20.1 The centre should give people seeking treatment with donated gametes or embryos:

…

It may be helpful to direct midwives towards the egg donation page of our website, where we set out that only in exceptional circumstances will egg donors be over the age of 35 (in line with current professional body guidelines). If an egg donor aged 36 or older is accepted, this is usually because they are a relative of the patient and will be a ‘known donor’.

February 2024 Scientific and Clinical Advances Advisory Committee (SCAAC) papers available

The papers discussed at the February 2024 SCAAC meeting are now available on the SCAAC webpage.

The Committee discussed the following:

The mitochondrial donation programme - An update was given by the Chair following a visit to Newcastle Fertility Centre.

SCAAC prioritised the following topics (in no particular order), identified through their horizon scanning process, for their workplan for 2024/25:

Alternative methods to derive embryonic and embryonic-like stem cells
Artificial intelligence (AI), robotics and automation in fertility treatment
Emerging technologies in embryo and gamete testing
Germline/heritable genome editing
Impact of long-term cryopreservation of gametes and embryos
In vitro derived gametes
Scientific considerations relevant to the ‘14-day rule'
Stem cell based embryo models
Testicular tissue transplantation to restore fertility in males
Treatment add-ons
Mitochondrial donation
Health outcomes in children conceived by ART (including the impact of culture media)
The impact of the microbiome on fertility and fertility treatment outcomes
Artificial wombs for early or whole gestation (ectogenesis)
The impact of stress on fertility treatment outcomes

Treatment add-ons ratings review - The Committee agreed that the review of ratings for treatment add-ons will take place every five years. Between reviews the Committee will continue to monitor research findings relevant to treatment add-ons and an ad-hoc review can be carried out for a particular add-on should new robust evidence of effectiveness be published

The Impact of long-term cryopreservation of gametes and embryos -The Committee highlighted there is an absence of conclusive data on the impact of long-term cryopreservation of gametes and embryos. Due to insufficient evidence, it is not possible to determine that long-term storage has no effect on the viability of gametes or embryos at this time.

Genome editing - The Committee concluded that significant further scientific research into improving the accuracy of genome editing technologies is required before germline applications can be considered in reproduction. The HFE Act does not permit interventions in the nuclear DNA of gametes or zygotes for the purposes of germline genome editing in reproduction.

Artificial intelligence, robotics and automation in fertility – The committee noted that innovation in this field is moving at pace and reiterated the importance of AI based models being appropriately developed and verified through robust research to support the validity of these technologies. The Executive have had a watching brief on developments in the uses of AI within clinics, including regular engagement with other relevant regulatory bodies, for some time. This work is ongoing and we aim to publish guidance to support clinics with the introduction and use of AI based models, as required, over the course of this year.

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

Job vacancy - Senior Inspector (Clinical)

We are recruiting for a Senior Inspector (Clinical) at the HFEA. If you have a clinical/nursing background and experience of working in a senior role in the related discipline relevant to healthcare, we would like to hear from you.

The job description and details on how to apply can be found here. The closing date for applications is Sunday 10 March 2024.

If you would like more information about the role, please contact sharon.fensome-rimmer@hfea.gov.uk.

Emerging technology of human stem cell-based embryo models – POSTnote publication

Yesterday, the Parliamentary Office of Science and Technology (POST), a research and knowledge exchange service based in the UK Parliament, published a POSTnote which summarises the emerging technology of human stem cell-based embryo models, discussions around their regulation and their wider ethical and societal implications.

The POSTnote can be found here.

Alert/Field Safety Notice reminders

Alert 2024/02 - Exeltis UK Limited Gepretix 100mg Capsules

Alert 2024/02 was issued on 5 February 2024.

Alert 2024/03 - CooperSurgical Origio® Sperm Wash Media

Alert 2024/03 was issued on 21 February 2024.

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. You can find more information about FSNs in the January edition of Clinic Focus.

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

Did you know?

In light of changes to the storage laws in July 2022, some clinics may be planning to make changes to their cryo-store area.

If a clinic is planning to make changes to its premises where licensed activity takes place, including relocating a cryo-store or changes to laboratory or theatre areas, as per Code of Practice guidance at 25.6 and 25.7, the PR should contact its inspector for advice.

An application for a variation of the licence with information on the planned changes will be required before the new area can be used, and the HFEA may need to inspect the premises.

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