The controversial issue of IVF 'add-ons' – techniques and treatments offered to fertility patients on top of standard IVF – has been the subject of intense debate and media attention since last November's BBC Panorama's documentary, which claimed that many techniques advertised on fertility clinics websites were not backed up by good scientific evidence of success (see BioNews 880).
The Progress Educational Trust debated the issue at its public event 'Fertility Treatment Add-Ons: Do They Add Up?', held at the Royal College of Obstetricians and Gynaecologists on 29 March. At the meeting, chaired by the Science Media Centre's Fiona Fox, a panel of the leading players in the field – the Human Fertilisation and Embryology Authority (HFEA), the British Fertility Society (BFS) and fertility professionals – tackled difficult questions about how to achieve good quality evidence in a fast-moving, innovate industry; how much evidence is needed before an add-on is offered to patients; who should make this decision; and what are the respective roles of fertility professionals, the BFS and the HFEA.
First to speak was Professor Adam Balen, chair of the BFS and also a signatory to a letter that challenged the reliability of the research (5) relied on by BBC Panorama ((1) – see also BioNews 880). Professor Balen said that it was important to put the techniques, some of which he said were necessary investigations and essential treatments – casting some doubt over the use of the phrase 'add-ons' – in the context of an innovative fertility industry characterised by rapid advancements in a tightly regulated environment. He said while there are indeed concerns about the evidence basis of some fertility interventions, the nature and complexity of IVF and fertility problems mean that standard tests of reliability – like randomised control trials (RCTs) – are difficult to conduct and may not always be appropriate (see, for example, Evers (2017) (2)). Instead, the focus should be on ensuring patients are fully informed about what clinics are offering (they have a right to choose, he said) but emphasised that clinics should practise in an ethically sound manner.
Next, Sally Cheshire, chair of the HFEA, outlined the recent work (3) of the Authority in this area, including its survey of fertility clinic websites carried out last year. This study identified that 70 percent of clinics offered at least one add-on – some were charged to patients, while others were offered free of charge. It then conducted a scientific review of the most common add-ons and found that most of them carried little evidence of effectiveness. Following on from this, the HFEA – which Cheshire pointed out does not regulate drugs or surgical procedures offered at fertility clinics – will soon launch a new website that will include information to help inform patients of techniques offered as add-ons. It proposes to use a traffic light system to inform patients about the quality or status of the evidence base of specific add-ons. The idea behind this is that patients can then use this information to make an informed choice when deciding to accept an add-on offered by their clinic.
The issue of reliable evidence was picked up by the next speaker, Dr Simon Fishel, Founder and President of CARE Fertility, who said that the fertility sector has always been characterised by innovative practices and that, for many procedures, performing a RCT (just one of a range of research techniques) may not only not be appropriate but could be quite unfeasible owing to the number of patients required. He stressed that if the sector always waited to conduct RCTs then it would lead to delays in the introduction of techniques and could slow progress down overall, which could otherwise in the meantime move on to produce more accurate technologies. As such, patients could then lose out and progress in the field could be stifled. While also acknowledging the need for effective fertility interventions, Dr Fishel suggested that a solution lay somewhere in patient consent and ensuring that this consent is properly informed and evidenced, as recommend by Harper et al (2017) in a recent paper (4). This view seemed to give further support to the approach being taken by the HFEA.
Finally, Dr Raj Mathur, consultant gynaecologist at Manchester Fertility and St Mary's Hospital, started by acknowledging that there does indeed appear to be a problem. Clinics advertise their use of add-ons as markers of quality or innovation, he said. With this comes a duty, however, to advertise responsibly, for example by placing the technique in its context and offering full information about it. Dr Mathur said that clinicians have a responsibility to protect their patients, who are at a heightened sensitivity and may be overly receptive to the claims linked to add-ons, and should take great care not to exploit unproven treatments for profit. However, the scope of this duty in the course of treatment was difficult to determine – is there a duty to continue treatment, for example, where a patient requests an add-on for which there has not yet been sufficient evidence basis for its effectiveness? This could, on the one hand, be potentially beneficial and accords with the patient's request but, on the other, could be seen as potential exploitation. Dr Mathur, therefore, advocated more onerous duties in respect to advertising and making a profit.
In the discussion that followed, questions were raised over the definition of an 'add-on' versus an innovative technique and the threshold of evidence required before a technique is offered to patients. Dr Fishel pointed out that research has to start somewhere, and that IVF itself would not have arisen if we were not prepared to do experimental things. He attempted to draw the line between innovative techniques and something that just doesn't work, however, saying that if it is shown that something doesn't work, then it shouldn't be used – although as was pointed out, in reality, this line is quite difficult to maintain.
Whatever the term used for add-ons, improving the evidential basis was necessary but a challenge, said Professor Balen. Although the complexity of IVF should not prevent the introduction of standard protocol, performing large-scale clinical trials was problematic since it was difficult to get funding and clinics to sign up – although some are taking place. The panel was in broad agreement that there is a need for better evidence, which was reinforced by Cheshire, who suggested that the sector should start by looking at a few of the common add-ons it had identified in its research and work to produce an evidence basis from there.
The issue of consent was also frequently returned to, with one comment from the audience pointing out that while it might be a laudable goal to seek to better inform patients, what happens when patients are overloaded with options? The traffic light system might work as a source of information, but how effective would it be without a clear duty of care from doctors? Another member of the audience – many of whom were also leading fertility professionals and policy workers – said that who provides the information to patients needs to be looked at. Patients trust their doctors and it may not be sufficient to simply declare an interest to patients when they are trying to get pregnant – patients will treat any option given by the doctor as a recommendation. Dr Mathur picked up on these comments and emphasised that we don't do enough to address the responsibility of clinicians and the culture of clinics.
Overall, the panel presented a broad consensus that the issue requires action and there appeared to be support for the HFEA's strategy to produce a better evidence base. While some of the challenges regarding price and the threshold for effectiveness provoked differences of opinion, it felt the solution presented lay in promoting informed consent and transparency. However, while there seemed to be a tacit agreement in bolstering the responsibility of clinicians, the content of these duties remained opaque across the debate. Without this discussion, the consent solution may therefore be at risk of operating as a mere procedural justification for what might, at times, remain an unethical practice.
Progress Educational Trust would like to thank the British Fertility Society for sponsoring this event.