Navigating the Fertility Maze: Understanding the new HFEA Add-On Ratings

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James Nicopoullos, Medical Director of the Lister Fertility Clinic

The Lister Fertility Clinic has long supported the HFEA’s development of a traffic light system as a tool to move towards a more consistent and transparent approach to the use of treatment add-ons in fertility services.

For individuals or couples embarking on the journey of creating embryos as IPs with the intention of pursuing surrogacy, selecting the right fertility clinic and treatment options can be overwhelming and the ratings system tool has helped those often vulnerable and occasionally desperate make informed decisions about optional treatments and procedures.

It has also aided clinicians who focus on appropriate evidence-based care in their conversations with patients who may have often read about the more extreme add-ons as a means to explain why any such treatment should not be used.

So, when I read that the simple rating system was to be updated and become more complicated I was initially a little sceptical. By classifying add-ons into amber, green, and red categories based on their evidence base, patients could navigate the complex world of fertility treatments with more confidence and clarity. Would and change actually just confuse us all??

The new system is, without doubt, more complex. But I believe it does in fact give even more clarity. The previous self-explanatory red (potential safety concerns or even decreased outcomes) and green (effective at improving outcome) remain but the more uncertain amber category is expanded into 3 new categories:

1. Conflicting evidence so not clear whether effective in improving outcome.
2. Insufficient evidence to rate this add-on at improving outcome.
3. Evidence shows no effect on treatment outcome.

In essence there is a difference between an add-on that has mixed evidence and may be of benefit, one that we can’t really judge yet and one that makes no difference, and this now allows us to differentiate.
As useful a tool as this is, it has its potential flaws and in to a certain extent could at first glance occasionally mislead.

Let’s use PGT-A (genetic testing of embryos) as an example which is probably the most relevant to intended parents. At first glance it appears to have a red rating until you dig deeper and in fact in some circumstances, they have given a green rating in reducing miscarriage and a grey in other outcomes! This is going to lead to considerable confusion.

It’s clear that genetic testing an embryo isn’t going to change it so will not improve the key endpoint, which is the chance of having a baby. But by avoiding the transfer of an abnormal embryo it can clearly mitigate miscarriage risk which is key in eliminating a huge physical and emotional burden on a potential surrogate as well as the emotional trauma to the IPs. Most would suggest when carried out correctly PGT-A could decrease time to pregnancy despite suggestions otherwise in the rating system which is another potential key benefit for those who have already been through an incredibly long process to that point. This is another area of potential confusion where real world everyday practice and common sense may differ from some studies used in the ratings system.

The key therefore is to ensure all individuals and couples have transparent information about add-ons based on the HFEA ratings but also you must have the opportunity to discuss your individual circumstance with your clinician to decide whether any add-on is right or wrong for your circumstance.

At the Lister Fertility Clinic, we’re here to help you navigate through the maze! Please contact us at info@lfclinic.com for more information.