IVF Add-Ons: How Should We Score the HFEA's New Ratings System?

Within the context of fertility treatment, an 'add-on' is an optional treatment, technology, or procedure offered alongside the core IVF protocol, often with little or no evidence of impact on outcomes. Clinics vary in what add-ons they offer (if any), and how these are priced.

While the UK's fertility regulator – the Human Fertility and Embryology Authority (HFEA) – is responsible for regulating fertility clinics, its power to regulate add-ons is limited, as many add-ons fall outside the regulator's statutory remit. However, the HFEA's responsibility for educating patients and providing information includes add-ons and the evidence around them.

In relation to this role, the HFEA has recently revised the way it classifies add-ons. From 2019, add-ons were ranked on a green/amber/red 'traffic-light' system (see BioNews 983), but this has recently been replaced with five new categories involving a revised set of criteria (see BioNews 1212).

To discuss the changes, PET (the Progress Educational Trust) organised an online chaired by Sarah Norcross, director of PET. Across two hours we heard from five speakers, each bringing a different perspective to how add-ons should be conveyed to patients and the wider public. The discussion concluded with questions from the audience, which reflected the importance of ensuring clear, easy-to-understand information to people considering or going through IVF.

Speaking first was Dr Tim Child, a member of the HFEA and chair of that regulator's Scientific and Clinical Advances Advisory Committee (SCAAC). Dr Child explained the role of HFEA in relation to add-ons in UK fertility clinics. Given that many add-ons fall outside HFEA's legally-defined scope of regulating what can be done to or with gametes or embryos outside the human body, the emphasis had to be on appropriate communication to the patient.

In the previous 'traffic light' system, add-ons were flagged as green, amber or red based only on the outcomes of randomised clinical trials, where the only metric-of-interest was whether an add-on improved the chance of a live birth.

As Dr Child explained, the HFEA felt that more nuance was required. Following consultation with patients, clinics, staff, stakeholders, the public, medical librarians and SCAAC, the HFEA recently introduced five new categories for add-ins with the aim of providing just that. The new scoring metrics incorporate data from wider sources including cohort studies, and look at outcomes for different sub-groups of patients.

The five categories include green (meaning an effective add-on, which can only be determined from at least one high-quality randomised clinical trial), yellow and grey (unclear outcomes, either due to conflicting or insufficient data), and black and red (no effect, or negative and unsafe effects). There was a clear emphasis on communicating efficacy and risk to patients. The system is not static, and Dr Child mentioned that HFEA is looking to improve communication where they can.

Next, we heard from Joyce Harper, professor of reproductive science at University College London, and Dr Ippokratis Sarris, director of King's Fertility. Professor Harper spoke from the perspective of a patient as well as a scientist, having undergone IVF herself.

Professor Harper was also a member of the working group that wrote the European Society of Human Reproduction and Embryology (ESHRE)'s good practice recommendations for add-ons, it was interesting to hear Professor Harper contrast the approaches of ESHRE and the HFEA. It was worryingly apparent that there was a lack of high-quality data for the efficacy of most add-ons, which is all the more striking when one considers the substantial cost to the patient. This theme was revisited in the Q&A, with Professor Harper speaking passionately about the need for more evidence and studies.

Dr Sarris talked about the challenges of conception, highlighting the fact that the success of fertility treatment has plateaued in recent years. One approach to measuring the success of add-ons, he said, might be contextualising their validity on a more individual basis. Just one-third of patients in a clinic might fit the profile of patients in a study, and some add-ons might be recommended for different patients based on their profile, including maternal age.

The last two speakers were Tracey Sainsbury, a fertility counsellor, and Dr Tasha Alden, a fertility patient who is also a senior lecturer in contemporary literature. Both of these speakers provided powerful personal insights into the fertility process, and how costly add-ons seem to be 'upsold' to patients who are in a vulnerable position. It was clear that the desperation of IVF patients might lead them to try anything promoted by a clinic, regardless of a lack of evidence. Dr Alden compare this to the way some cancer patients might try a treatment with no proven clinical benefits, as a last resort.

Sainsbury argued that patients need a degree of autonomy in their treatment, but questioned why - if the HFEA deems an add-on to be 'red' (ie, not effective and/or with possible safety concerns) - clinics are allowed to offer such treatments to patients. Evident from both Sainsbury and Dr Alden was the stress and disappointment that might come with pursuing fertility treatment, and the need for clinics and the HFEA to manage expectations and provide clear, useful information.

Questions from the audience then followed up on points that had been raised during the presentations. Part of this discussion queried why preimplantation genetic testing for aneuploidy (PGT-A) was still available as a search criterion for finding an IVF clinic on the HFEA website, given that it is an add-on. Indeed, after this event I looked at the websites of some London-based fertility clinics, all of which offered PGT-A – something that is not recommended by either HFEA or ESHRE – at a cost of thousands of pounds.

The general consensus from this event is that the HFEA's five-category ratings system for add-ons is a step in the right direction. This system was itself cheekily rated 'grey' by Dr Sarris using its own metrics, indicating a need for more data. As highlighted by all speakers, there is a pressing need for better unbiased information, to make sure patients are pursuing appropriate treatment.

A personal takeaway is that fertility clinics should take responsibility for improving their own communications. Fertility treatment is often expensive, and can be very stressful for patients. Adding extra treatments with no clear benefits is likely to add to both of these burdens.

The next free-to-attend PET events will be:

• Welfare of the Fertility Patient: Spotting Signs and Treatment after Trauma, taking place online on Wednesday 13 March 2024 – register here.
• Mary Warnock at 100: The Architect of Embryo Law?, taking place online on Wednesday 17 April 2024 – register here.
• 40 Years of Egg Donation and Counting: What Have We Learned? What Happens Next?, taking place online on Wednesday 24 April 2024 – register here.