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The HFEA's monthly newsletter for clinic staff

August 2024

Incident reporting and licence suspension

In March 2024 the HFEA Licence Committee (LC) made the decision to suspend the Homerton Fertility Clinic's licence due to the potential risks to the safety of patients, gametes and embryos following three reported incidents. A decision to suspend a licence is not taken lightly and is a rare event in a widely safe sector.

When an incident occurs, there is a legal duty to report the incident to the HFEA. We then require a centre to conduct a robust investigation and most importantly ensure any lessons learnt are taken forward. After closely working with the centre in this case and receiving a report from the clinical governance team at the HFEA, the LC is now satisfied that the centre has put measures in place to mitigate risks and provide safe and effective care to patients and therefore the suspension has been lifted.

Sharing best practice and lessons learned is beneficial following incidents and, in this case, we would like to remind PRs of the importance of scrutinising their own KPIs, having robust mechanisms to check competencies, ensuring standard operating procedures (SOPs) are up to date, and validating processes.

HFEA calls on patients to help shape the future of UK fertility treatment

Your patients can play a pivotal role in shaping the future of fertility treatment in the UK, as we prepare to launch our third National Patient Survey.

The HFEA carries out a survey every three years exploring the patient experience, from accessing GP services through to patients’ most recent fertility treatment. This helps us identify how the experience of fertility treatment in the UK has changed.

The survey will be open from 2 September 2024 for patients, surrogates and intended parents through surrogacy that are undergoing treatment, or who have had treatment in the last five years.

We’d appreciate it if you could share the below QR code with your patients – please note the link will not go live until Monday 2 September.

Virus update

Currently there is an increase in the number of viruses that have been reported throughout Europe including Chikungunya, Dengue and West Nile Virus. In addition Mpox, a viral disease which is endemic in central and West Africa, is on the increase and has led the World Health Organisation (WHO) to declare a public health emergency of international concern.

Actions for clinics

Staff should pay particular attention during medical interviews and be alert for donors/patients with a history of rashes and illnesses consistent with the above viruses, regardless of sexual behaviour, travel history and or other risk factors.

We advise that you check the JPAC website and GOV.UK website on a regular basis for any relevant updates.

Latest HFEA report, ‘Fertility Treatment 2022: Preliminary Trends and Figures’, published

New data from our latest report, Fertility Treatment 2022: Preliminary Trends and Figures, shows treatment numbers and pregnancy rates have risen overall as:

Average age of first-time fertility patients is now over 35 years old for the first time
8,000 (11%) more IVF cycles across the UK in 2022 compared to 2019
Multiple births from IVF have fallen to the lowest average yet at 4%
NHS-funded IVF cycles dropped to 27% in 2022 from 40% in 2012

There is a large gap in the average age that women in England and Wales gave birth to their first child in 2022 (29.2 years according to ONS figures) compared with the age of patients accessing IVF for the first time in 2022 (35.1 years). This highlights both the necessity of early contact with a GP and an early referral to fertility services.

Across the UK, average IVF pregnancy rates using fresh embryo transfers increased nationally to 31% per fresh embryo transferred in 2022, from 21% in 2012. The highest pregnancy rates, at 42%, were among patients aged 18-34. Pregnancy rates improved across all age groups.

Other findings from the report include:

Around 52,500 patients had IVF treatment across the UK in 2022, compared to 50,000 in 2019
Treatment numbers increased on pre-pandemic levels, with IVF cycles increasing by 11% between 2019 and 2022, while donor insemination (DI) returned to pre-pandemic levels of around 6,000 cycles.
Egg storage cycles made up just 5% of all cycles in 2022, an increase of 81% from 2019 to 2022.
Most IVF patients (46,145) were in heterosexual relationships, accounting for 90% of all IVF patients. The number of single patients undergoing IVF increased by 82%, from 1,953 in 2019 to 3,548 in 2022.
Of those undergoing DI, most were single (50%), followed by patients in female same-sex relationships (41%).
The overall number of NHS-funded cycles decreased once again across the UK and has now fallen from 40% in 2012 to 27% in 2022.
Multiple births from IVF have fallen to the lowest average yet, at 4% in 2022 from 28% in the 1990s.

You can read the full report here, and updated data can be found on the HFEA dashboard here.

Our work on Artificial Intelligence, robotics and automation in fertility treatment

In response to the growing interest in using Artificial Intelligence (AI) in fertility treatment, the HFEA has been increasing its strategic focus on AI. AI was introduced as a high priority topic in the HFEA’s Horizon Scanning in 2019, and has been reflected in our 2020/24 strategy.

Our Scientific and Clinical Advances Advisory Committee (SCAAC) continue to watch/follow the current and future uses of AI within fertility treatment, and this topic was last discussed at their February 2024 SCAAC meeting. We will continue to monitor the uses of AI in the fertility sector and respond to any regulatory questions.

Clinics should refer to the HFEA’s Code of Practice, in particular guidance note 4 (information to be provided prior to consent), guidance note 18 (using of electronic systems for witnessing), guidance note 23 (the quality management system), guidance note 27 (adverse incidents), guidance note 31 (record keeping and document control), and licence conditions T32-T36, on 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.

Reporting of outcomes

Reporting of outcomes for completed treatment cycles is an essential requirement of all treatment centres. PRs are under a legal duty to comply with their clinic’s Licence Conditions, in this case SLC T39, which relates to the provision of information as specified in General Directions 0005.

Accurate submission of live birth outcome information is essential for the integrity of HFEA Register data, used in HFEA publications and by researchers. This information is crucial for evaluating and reporting on the success rates of UK fertility treatments.

Submission of live birth outcomes also ensures the accuracy of Choose a Fertility Clinic (CaFC) success rates. Missing or incomplete data can distort information provided to the public, subsequently impacting information on donor conceived live births and Opening the Register (OTR) applications, or where information on unsuspected heritable conditions in donors is discovered. It can also impact the 10-family limit count for treatments using donors.

Later this year we will be including guidance for patients on our website explaining why outcomes need to be collected. Once this is live, we will share the link so you can signpost this to your patients to help them understand how their information is used.

What to do if the full range of outcome data is not obtainable

When the full range of outcome data is not obtainable, the HFEA still must know if a live birth has occurred. For CaFC purposes the minimum essential information is baby weight, baby gender and delivery date. Further desirable information that is the baby’s forename, surname and country of birth, as this helps positive identification with future potential OTR applicants.

If you have some, but not all, of the essential live birth information elements (for example baby gender and delivery date, but not weight), then please still submit this. The HFEA register team can suppress any subsequent ongoing errors in PRISM, should you need to contact them on this.

If a patient is completely uncontactable then cycles can be marked as ‘lost to follow up’ - however this option should only be used a last resort as ‘lost to follow up’ cycles are included in CaFC success rate calculations as treatment cycles that started but that did not lead to a successful live birth, and as such, will negatively impact CaFC success rates.

If you know that a live birth has resulted from treatment, but have no additional information, then please submit that as an outcome and contact the Register team (register@hfea.gov.uk) to remove remaining errors. Again, this should only be done if multiple attempts to contact the patient have failed.

Our latest clinical governance summary report

We have published our latest clinical governance summary report that covers some of the common non-compliances identified at inspections, reported incidents and complaints received from January to March 2024.

The aim of this report is to highlight key areas of practice where improvements can be made, or where learning and experiences can be shared to benefit other clinics.

To promote learning from inspections we encourage you to use the areas outlined in this report as an opportunity to consider how your clinic might approach these issues.

The HFEA, in line with other healthcare regulatory bodies, promotes an open reporting culture where healthcare professionals are more likely to learn from incidents when they feel safe and secure reporting them internally and externally to the appropriate regulatory bodies.

Alert reminder

Alert 2024/11 – Field Safety Notice: Beckman Coulter, Power Express Centrifuge

Alert 2024/11 was issued on 20 August 2024

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.

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

Did you know?

Guidance on how to use each HFEA consent form and statutory notice can be found in ‘Consent Forms: A Guide for Clinic Staff’, available on the Clinic Portal.

In relation to signing declarations, inconsistencies have been identified during the inspection process as to how centres are directing patients to complete HFEA consent forms. Centres should refer to pages 6 and 7 of this guide titled ‘which declarations should patients sign?’, to ensure all HFEA consent forms are signed appropriately.

Patients should sign each page declaration - even if that section does not apply to them - as well as the declaration at the end of the consent form. This applies to both paper and electronic consent forms, and clinics should ensure that any electronic platforms are compliant with this practice.

Failure to ensure HFEA consent forms are completed correctly by the patient may render the consent invalid.

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.

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