In June 2021 Manuela Perrotta and I responded to the government’s call for evidence to inform their forthcoming Women’s Health Strategy for England. The government consultation received over 110,000 public survey responses and over 400 written responses. Just before the December holidays, the Department of Health & Social Care published their vision for the Strategy based on the responses received. Reflecting the sentiments shared in the public survey, the department’s vision highlights fertility, pregnancy, pregnancy loss and postnatal support as particular areas of concern. This grouping of priority areas was the second most selected option across all survey participants (after menstrual health and gynaecological conditions), and the most selected priority area for those aged 30 to 39. Infertility and fertility treatment are integral parts of this broader concern with reproductive and maternal health.
The vision document highlights the need for ‘more trusted and easier to understand information’ about women’s health issues, including reproductive health, which is a key point that we address in our written evidence. In our submission we emphasised that there is an abundance of information about infertility and fertility treatments, especially online. But prospective and current fertility patients often find the information difficult to navigate and identifying good quality information can be challenging. We found that our study participants generally felt that NHS websites offered good sources of reliable information. In our written evidence, we suggest ways for NHS websites to expand their remit to cater for fertility patients’ needs. We were excited therefore, to learn that one of the next steps for the Strategy will be to progress the quality of online information in collaboration with NHS Digital. We hope that the needs of fertility patients will be addressed in this continued work. We also look forward to following further developments as well as the government’s dedicated Sexual and Reproductive Health Strategy, which is expected later this year.
Over the past few months, the research team has participated in a number of events where we have discussed our findings and engaged in stimulating conversations with IVF patients and professionals (you can see a list of our past events and links to event reports on the Events page). In many of these conversations, we offered reflections based on the results of our social science research project, often focused on the debate on evidence and treatment add-ons. As this debate is very polarised, we have sought to highlight how our findings show a variety of perspectives on add-ons and their use, from the points of view of both professionals and patients. For instance, in our written evidence to the UK government’s Women’s Health Strategy, we underlined how the patients we interviewed expressed concerns regarding the abundance of information available online on IVF treatments (and especially add-ons) from multiple sources. Patients are exposed to a variety of claims without being able to assess their reliability. In contrast, the HFEA website offers impartial, accurate and up-to-date information, but this is currently limited to the evidence available to determine whether, for most fertility patients, a certain add-on is effective at improving the chances of having a baby.
This tool offers great clarity in terms of available evidence for both professionals and patients, but, as the evidence supporting add-ons is still scarce or of low quality, none of the add-ons on the list are currently green. In addition, and in some circumstances, add-ons may be offered for reasons other than to improve the chances of having a baby. To enable patients to better-understand the risks and potential benefits for each add-on, in April 2021 the HFEA included a list of questions that patients might ask their clinicians when discussing add-ons. These questions include a variety of aspects, such as: Is there good-quality evidence to back this up? Are there any associated risks or side effects from having this add-on? Am I assured that it is safe? and Do I know about any possible risks?
Both in our discussions with patients during our The IVF Experience events (which you can read about here and here) and in our interview with BBC reporter Sophie Sulehria as part of the Fertility Show’s live seminar series, we discussed these same issues, and how our research findings can support patients’ informed decisions. In particular, in our interviews with IVF professionals, different understandings of the meaning of the HFEA traffic light system emerged. Some interviewees understood the add-ons marked red as the problematic one, while they were more lenient toward those marked amber as they considered these promising. Other professionals, instead, were more worried about the add-ons marked amber. For this group in fact, add-ons marked red are clearly-identifiable as lacking supporting evidence, while amber ones might give patients the illusion of being more effective, while in actuality there is, equally, no evidence supporting them. Similarly, our interviews with patients show very different understandings of what constitutes “evidence”. Josie Hamper and I are currently working on an academic journal article that discusses four different approaches to evidence in relation to IVF treatment add-ons. While the majority of our patient participants preferred to delegate evaluations of evidence in IVF and follow the advice of their clinic or consultant in relation to treatment decision-making, other interviewees had a more direct assessment of evidence: some engaged in critical evaluations of evidence; others acknowledged the complex process of making evidence; and others relied on embodied experiences of evidence. With such a variety of points of views, a discussion on what kind of misunderstandings these may create with health professionals and institutional bodies is needed. We attempted to foster this discussion with one of our video animations: What is Evidence in IVF?
Drawing on our research and these discussions, we elaborated a proposal that goes in the direction of offering more information to patients, that we presented in our last workshop in collaboration with PET. In line with the ongoing HFEA discussion on how best to evolve the rating system for add-ons information and to consider the strength of the evidence base for each add-on, we suggested two main additions.
Firstly, we suggest including other criteria of evaluation for each add-on, including not only the available evidence on the ability of an add-on to improve the chances of having a baby, but also other relevant aspects for patients. This might include their safety and other potential effects on patients’ experience of IVF; for instance, the reduction of miscarriages and the reduction of time to conception. This would offer concrete support to make informed decisions for all the patients who are considering including add-ons in their treatment for reasons other than, exclusively, so as to improve the chances of having a baby. In addition, this would offer all patients more detailed information on each add-on, which they can then further discuss with their consultant.
Secondly, we suggest including additional indications on the quality of evidence available. Considering the current lack of quality evidence (i.e., more than one high quality RCT), including information regarding lower quality evidence – while highlighting that this evidence is not the best possibly available – would benefit those patients who need more clarity on why some recommendations are offered. In this case too, having reliable and detailed information available would enable patients to engage in conversations with their clinics on what the good-quality evidence they use to back up the use of add-ons is.
We anticipated two main disadvantages on offering such a detailed level of information: first, collecting and evaluating these different forms of evidence is time- and labour-intensive, and it would be a “village” effort requiring the collaboration of many members of the scientific community; second, making publicly available a summary of the currently available evidence would require agreement on a number of principles on what evidence should be included and what is too low-quality to be considered. Based on our findings, we believe being able to receive information from one reliable source would benefit many patients who are currently having to navigate information from a vast range of sources, many of which are less reliable.
During the workshop, an interesting discussion emerged on the use of the term “safety” among the criteria we suggested. For some workshop participants, this term is too ambiguous, means different things for various people and would be difficult to implement in terms of assessment. A suggestion by Katy Linderman, one of the guest speakers at the event, was to offer additional information on the potential “harm” that add-ons might have, including the risk of reducing the chances of having a baby through IVF. In line with the current HFEA discussion, it is extremely important to distinguish between the lack of evidence on a certain add-on, and the available evidence that an add-on is not safe (i.e. might somehow harm patients or reduce rather than increase their chances of having a baby through IVF).
Based on our research results and expertise, it is important for us to clarify: our proposal to share publicly the available evidence to best support informed decisions focuses on the content of the information that should be shared, rather than on how this is communicated. For this reason, we are not suggesting changes in colours or to add symbols in the visual representation of a ranking systems. Other research groups working on the best ways visually to share information are better positioned than us to provide recommendation on this.
In June 2021, Manuela Perrotta and I submitted written evidence to the UK government’s Women’s Health Strategy for England. We believe the consultation presents a key opportunity to improve the treatment experiences of IVF patients.
In our response, which you can find in full on our Publications page, we make five policy recommendations:
Women need a more coordinated provision of up-to-date information about IVF, especially information about novel IVF treatment add-ons
Improving the clarity, visibility and accessibility of already available information is a relatively low-cost measure that will bring timely positive change for IVF patients
There is an opportunity for the NHS A-Z website to direct IVF patients to the Human Fertilisation and Embryology Authority’s website for information specifically about new IVF treatment add-ons
Different understandings of evidence should be considered to improve the quality of information on new treatment add-ons
Accurate information about the nature of available evidence should be provided when treatment add-ons are experimental
We are very grateful to Inflect Partners for their advice in preparing our submission for this call.
We go to many exciting conferences and events throughout the year. Fertility Fest, however, is very special in that it bridges the gap between art and science, lay and professional. Infertility as a topic of discussion stirs intense emotions and Fertility Fest provides a very much needed outlet to express such feelings and have conversations about them. Eager to immerse myself in this year’s festival, I attended the Big Fat Festival Day this May. I must also mention here that the 2019 venue, The Barbican Centre, was a fabulous fit and contributed to the convivial atmosphere of the festival.
When it comes to infertility and IVF treatment, some topics come up more often than others. As such, I would like to focus on the conversations that stood out for me this year – the conversations that, I thought, were novel and really made me think about some of the more painful and uncomfortable questions. For example, what happens when IVF treatment doesn’t work? When our hopes and dreams disintegrate? How does one re-evaluate their life and choices? How does one grieve? And is there meaning to life beyond having children?
During the opening session, Lisa Faulkner talked about her personal journey and the decision to adopt. Her experience really conveyed the difficult choices one has to make after several failed rounds of IVF. This issue seems poignant to me, yet seldom discussed. How does one know when to say no when we put so much emphasis on hope and being positive? Lisa talked about her initial reluctance towards adoption – something that I found refreshing. There are too many people who assume that adopting should be an easy decision for infertile couples, when, in fact, it is not. It was apparent to me that we need to have more conversations about adoption, who it’s for and who it isn’t for.
The Invisible Man was the morning panel that piqued my interest (but, trust me, it was very hard to choose). The focus on men made me reflect on the tough situations that are particular to the male experience of infertility. Elis Matthews talked about being diagnosed with azoospermia and struggling with identity, faith and the meaning of life. The devastation of hearing the word ‘zero’ (sperm) from a doctor really drove home how insensitive some medical encounters can be. Elis, however, admiringly managed to find humour in the situation. Men talked more generally about having to deal with tough questions about meaning and fulfilment – questions that they had to confront because of their experience with infertility. As a woman, I was moved to hear actor and writer Rod Silvers talk about feeling that he had failed his partner when he found out he might not be able to ‘provide’ her with biological children. I wondered if we really understand what infertility means for a couple as a unit, not just individually.
The highlight of the day, for me, however, was the premiere of Irina Vodar’s documentary Anything You Lose: a movie that intimately captures her infertility journey over 7 years. The camera follows Irina and her husband to multiple clinics, documenting their pursuit of parenthood. Heartbreaking moments of disappointment invite the viewer to reflect on the emotional toll that infertility takes on couples. Echoing the questions I outlined above, Irina’s story forces her and the audience to ponder the meaning of life without children and what we do when things don’t go the way we planned. What I appreciated most about Anything You Lose it that it doesn’t fall into Hollywood clichés about infertility. It doesn’t gloss over the complex medical procedures and decisions that patients have to make. It also shows the toll that infertility can take on relationships and the raw emotions it brings out of people. I came out of the Barbican Centre with many things to think about. In fact, I am still pondering questions as I’m writing this post.
Since the start of the ‘Remaking the Human Body’ project there have been some significant developments in debates around the state of fertility treatment in the UK. Just over two years ago, BBC Panorama presented a documentary entitled Inside Britain’s Fertility Business (28 November 2016) that questioned the quality of scientific evidence to support ‘add on’ treatments in IVF. In this context, add ons refer to treatments, procedures or tests that are offered in addition to ‘standard’ IVF. These are often available to patients at additional monetary cost.
The Panorama documentary emphasised that some treatments are offered to fertility patients without being supported by rigorous evidence that they work, and it set out concerns about patients not being fully informed about the limitations of these treatment options. Designed to provoke, the documentary opened with three questions that revolve around trust, effectiveness and patient protection (reproduced in direct quotation here): can we trust everything Britain’s multimillion pound fertility industry tells us; how effective are the treatments offered to thousands of couples by fertility doctors; and should Britain’s fertility patients be better protected?
The discussion around add ons was once again reinvigorated following the publication of findings from a randomised control trial undertaken in Australia that presented no clear evidence that one particular add on, the endometrial scratch (where the lining of the womb is ‘scratched’ to help the embryo implant), improves live birth rates. This research was presented at a European embryology conference (see Alina Geampana’s post on her visit to this conference here) and prompted media attention to the moral quandaries of patients undergoing, and often paying for, treatments that are still-to-be proven (see for instance this article by the Guardian).
The position of time-lapse embryo imaging
It has been important for the research project to follow discussions about add ons, given that time-lapse embryo imaging technologies are included in the Human Fertilisation and Embryology Authority’s (HFEA) list of add on treatments, and I am particularly interested in how these debates might relate to patient experiences of IVF. At the time of writing, the HFEA categorises time-lapse as ‘amber’ in their traffic light rating system, which means that early studies on the effectiveness and safety of time-lapse have produced promising results but more evidence is needed to support its use.
Improving patient information
Since the Panorama documentary, questions about add on treatments continue to shape the UK media landscape around reproductive technologies and have periodically re-emerged in public debates. These debates often revolve around the need to improve the information that is provided to patients about their treatment options. For instance, the HFEA’s 2017-2020 strategy includes the aim to ‘increase patients’ understanding of the science and evidence base behind treatments and added extras known as add ons, and of their safety and effectiveness.’ Following this, in the summer of 2017 the HFEA launched a fertility patient survey that investigated patient experiences of add on treatments. While the majority of respondents (at 66%) felt satisfied with the information they received about add ons and their evidence base, a large proportion (at 34%) also felt that they had not received enough information and 44% rated their overall experience of being offered add on treatments as negative. Concerns that patients had about add ons were often related to the price of treatment combined with complex emotional pressures to try ‘anything’ in the hope that it might work. A summary of the 2017 survey results can be found here.
A more extensive follow up survey was commissioned by the HFEA during 2018. The results of this survey showed that 77% of fertility clinic users who had used an add on were satisfied with how open and transparent the costs of these were. And 69% felt that they understood the scientific evidence around the effectiveness of add on treatments. Interestingly, this survey included a much broader categorisation of add on treatments than the official definition that appears on the HFEA’s website; for instance, it included massage, meditation and ‘other complimentary treatments’ within the response options for add on treatments. Importantly, the survey also found that patients’ experiences of add ons was shaped by whether they were undertaking fertility treatment on the NHS or privately, as well as how many cycles they had been through so far, where people in later rounds of IVF were more likely to consider additional treatment options. The full 2018 survey report can be found here.
In the summer of 2018, the HFEA published the 9th edition of their code of practice, which includes new and more explicit text that requires fertility clinics to inform prospective fertility patients about the add ons that they may be offered, as well as any evidence of their effectiveness or potential risks. This is significant in that it places the responsibility to provide appropriate information on clinics rather than relying on individual patients to make informed choices. Later on in the autumn, the HFEA also published a short statement about add on treatments, which once again emphasised that fertility patients ‘deserve consistent, evidence based treatment’ and reiterated their concern ‘that too many patients are being offered unproven treatment add-ons.’
Patient information, evidence and hope
The HFEA plays a central role in shaping the regulatory framework around fertility treatment by emphasising the importance of unbiased, clear information; however the Panorama documentary touched on an important difficulty in the debate around add ons, which is the disconnect between a commitment to evidence in a fast-moving medical field and the fact that patients are drawn to the promise of hope in navigating their treatment options. While Panorama highlighted that hope is not a good enough justification for using treatments that are unproven, from a patients’ perspective the offering of hope may have extremely powerful appeal. As one IVF patient explains at the end of the documentary: ‘with all these add on treatments, it kept us going that there is still hope.’ Fertility author Jessica Hepburn has also written very poignantly about her desire to ‘try anything’ – regardless of whether it is evidence based – during her eleven attempted IVF cycles.
The conventional notions of patient information and ‘informed choice’ are important but do not fully recognise all the other factors that impact on how people feel about their treatment options and how they weigh up the perceived harms versus potential benefits. Hope, for instance, is a very central emotion and strategy that plays into patient experiences of IVF as well as their treatment decision-making. The importance of having hope makes a lot of sense given that patients are undertaking a procedure that has, according to the HFEA, a less than 30% success rate. Our interviews with IVF patients in this project are still ongoing, yet there are already narratives emerging from the interview material that offer some initial insight into the complex nature of making decisions in a context where consequences and outcomes are, at least partially, unknown.