We are happy to share a film documenting our final public engagement event “Adding Up What We Know: A Global Perspective on Fertility Treatment Add-Ons” in January. This film was produced in partnership with the Progress Educational Trust. More information on the film is available here.
The final part of our public engagement event series took place on 26 January. This event was organised by the Progress Educational Trust (PET) and chaired by Sarah Norcross, who has been involved in several other of our public engagement activities. PET has a substantial track record of engaging in debates about IVF treatment add-ons and it was a privilege to partner with them for this event. Norcross’ review of the event in BioNews sets out some of their previous work in this area.
The event was entitled Adding Up What We Know: A Global Perspective on Fertility Treatment Add-Ons and it was opened by Kersti Lundin, the previous chair of the European Society of Human Reproduction and Embryology (ESHRE). Lundin spoke about the work that ESHRE is currently undertaking to update their good practice recommendations for IVF add-ons. ESHRE’s working group has identified 33 add-on interventions, which are categorised into four groups: diagnostic tests; laboratory interventions; clinical management; and selective add-ons. Lundin opened on a positive note by emphasising how add-ons can often be beneficial, despite often being surrounded by negative press.
Categorising add-ons is always going to be challenging, Lundin explained. Whereas add-ons are usually defined as optional, there are some interventions that are necessary for certain groups of patients. ICSI is an example of a procedure that may be considered optional or unnecessary for some but essential for others, such as couples with male-factor infertility. Lundin emphasised the role of patient-facing fertility professionals and the importance of giving patients realistic expectations as well as evidence-based advice about treatment safety.
Next, Manuela Perrotta presented some key findings from the Remaking the Human Body project. She highlighted how both IVF patients and professionals in our UK-based research had very diverse interpretations of what counts as an add-on, yet the element of financial cost to the patient was often raised as a key defining factor.
Following Lundin, Perrotta also highlighted how professionals and patients appreciate how certain add-ons may be beneficial for certain sub-groups of patients, which complicates the standardisation of guidance about add-on effectiveness. Based on research findings, Perrotta presented three recommendations for how to support patient decision-making in IVF: firstly, to coordinate and increase the visibility of already available information on add-ons; secondly, to include further information about various criteria beyond live birth rate; and thirdly, to provide further layers of information about the evidence that is available to support the use of add-ons. These recommendations reflect those made in our written evidence for the government and are further discussed in this blog post.
Moving on to a different geographical context of IVF, Sarah Lensen reflected on the place of add-ons in Australia and New Zealand. Limited data on the availability of add-ons in these countries led Lensen and colleagues’ research into how add-ons are marketed on fertility clinic websites. She found that the websites for 31 out of 40 surveyed clinics (or 78%) listed the availability of one or more add-on(s) at that particular clinic. The most commonly advertised add-ons were PGT-A, time-lapse embryo imaging and assisted hatching. Many of the add-ons advertised (77%) were accompanied by claims of benefit, such as claims of improved pregnancy chances.
A follow-on study by Lensen and colleagues surveyed IVF patients and found that the vast majority (at 82%) had used one or more add-on(s), and many of these had come at an additional financial cost to the patient. Notably, around half of participants had learned about add-ons from fertility specialists, rather than seeking this information on their own accord. Following this, the study found that many patients did not feel alone in their decision about whether or not to pursue particular add-ons, but that this was a decision that they shared with fertility specialists.
Satu Rautakallio-Hokkanen, chair of Fertility Europe, presented the results of a small survey of Fertility Europe members. In this survey she found that over half of respondents had learned about add-ons from online research, and about a third from private fertility clinics. She noted that many of the respondents were not familiar with add-ons, or perhaps they were unclear about how add-ons are defined. Rautakallio-Hokkanen reflected on why fertility patients are often willing to try unproven add-ons. She noted how patients might focus on the potential benefits, however tenuous, at the expense of considering the potential for risk or harm. Moreover, she reflected on how add-ons can make patients feel more hopeful about their treatment, especially patients who feel that they have exhausted all other options. This point spoke closely to our research findings, which highlight the importance of considering patients’ decision-making in relation to their broader experience and stage of treatment.
In the fourth presentation, entitled The Ethics of ‘Add-ons’, Sigal Klipstein discussed the challenges of assessing the science behind add-ons. Innovation has to start somewhere, usually with a theory or anecdotal evidence, which is then pursued through experimentation. This is a necessary step before new treatments can become part of standard care, but it raises important ethical questions about patients’ involvement in the early development of new interventions.
Klipstein emphasised the difficulty of engaging in conversations with patients about the risks vs. potential benefits of certain add-ons, or in conveying exactly what is meant by an unproven or experimental treatment. By undertaking certain treatments, the patient may unknowingly be the research subject. Others are, of course, fully aware that they are participating in an experimental treatment and are willing to take a high risk, even when there is potential for harm. Klipstein closed her talk by posing a series of open questions, including whether or not physicians are obligated to present ‘options’ to patients, especially when it is their professional assessment that the treatment will not offer any benefit to the patient or may even harm their chances of pregnancy.
The final presentation of the evening was by Peter Thompson, chief executive of the Human Fertilisation and Embryology Authority (HFEA). Thompson spoke about the work that the HFEA has done on add-ons, which started in 2016, and their ambitions for the future. On the agenda is a review of the HFEA guidance for patients about add-ons, especially the traffic light system. He explained the challenges of providing useful information for patients in a field that is characterised by rapid change. Speaking to the previous presentations, Thompson discussed the evidence base that the HFEA uses to evaluate add-ons. Currently, add-ons are assessed based on whether there are randomised control trials that show they improve live birth rates. Yet Thompson noted how there are other measures that are relevant to certain patient groups, such as whether an add-on reduces miscarriage rates, and there are also other kinds of evidence that can be valuable. Big data, for instance, is a resource that has the potential to provide robust indications of effectiveness but is not currently being utilised in this way. The HFEA’s work on this continues and will be going out to consultation in 2022.
We would like to thank PET for organising such a stimulating event and all the speakers for their contributions. A video of the panel discussion will be made available by PET in early 2022.
We invite you to a free online event organised in collaboration with the Progress Educational Trust. Some of our findings from the Remaking the Human Body project will be presented at this event.
Title: Adding up what we know: A global perspective on fertility treatment add-ons
Date: 26 January 2022, 5.30pm – 7.30pm.
Further details and registration can be found here.
During this event, a panel of speakers will present a global perspective on fertility treatment ‘add-ons‘ – optional treatments or procedures offered alongside IVF, often at considerable expense to the patient, which may not be supported by reliable evidence. The event is open to all; fertility professionals, fertility patients and anyone else who might be interested.
Please join us!
This event marks the end of our public engagement event series. A list of our previous events can be found on our Events page.
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.
At the beginning of December, we kept up our tradition of attending the Progress Educational Trust’s (PET) annual conference. The title and topic of this year’s online event was ‘Reproducing Regulation: Who Regulates Fertility and How?’ With 16 talks across the full day, I have chosen just a handful here that I thought were particularly pertinent to the issues that we consider in our research.
The first speaker of the day was Julia Chain, chair of the Human and Embryology Authority, who had made headlines in the run-up to the conference with her call for changes to the 1990 Human Fertility and Embryology Act. Her proposed changes would enable the HFEA to impose economic sanctions on fertility clinics that mis-sell unproven treatment add-ons. While she emphasised that her call was not a complete rejection of the current regulatory framework, she highlighted the need to update certain areas of the act to reflect the current state of society and the fertility sector. Currently, she noted, the HFEA has no powers to regulate the increasingly commercialised provision of services. Private fertility treatment is increasingly the norm in the UK, with 65% of IVF treatment being self-funded by patients themselves.
Reflecting on the commercialised fertility sector, Raj Mathur from the British Fertility Society brought attention to questions of fairness and equity and the lack of NHS funding for fertility treatment. Many prospective patients, he reminded us, do not have any access to IVF and when they do, affordability is a huge cause of concern. Mathur spoke about the challenges for patients who have to navigate very complex regulations around the provision of funding, before they even reach the point of having to choose between different treatment offerings.
A significant challenge to regulating the fertility sector is the fast pace of innovation. In her talk entitled ‘What is an add-on, and who gets to decide?’ Anja Bisgaard Pinborg, a specialist in reproductive medicine at Copenhagen University, detailed the difficulties of regulating add-ons safely without stifling the progress of medical research. She explained how the European Society of Human Reproduction and Embryology (ESHRE) is working on a new guideline for regulating add-ons. This guideline includes a very extensive range of tests, treatments and techniques, which reflects the vast and complex offerings of the fertility sector. While Bisgaard Pinborg recognised the obligation of clinics to offer the best treatment to their patients and the strong desires that patients may have to try certain (perhaps more experimental) treatments, she also highlighted that patients should never bear the cost of innovation. Patients, she argued, should not pay for add-ons that are still under development. How fertility patients and professionals navigate the complex world of IVF add-ons is something we have covered extensively in our research publications, workshops and in this blog post on how to best support patients’ informed decisions.
Further examples of how the law and regulation lag behind change were raised by Emily Jackson later in the day. Jackson set out how definitions of ‘mother’ in UK fertility law do not easily apply to the new social and family formations that are enabled though reproductive technologies. Currently, the legal definition of mother is defined in terms of who physically gives birth to a child. One of the examples presented by Jackson involved the case of a child that has two female parents at birth. In this case, the person who gives birth is the mother and the partner is the second legal parent. This is also the case when the partner’s egg was used in the IVF treatment. Interestingly in this case, as Jackson pointed out, the second parent is actually the child’s closer genetic relation. Fatherhood on the other hand, is expressed in both genetic and social terms, which allows for greater flexibility and choice in how fatherhood is defined.
Again, this year’s PET conference succeeded in traversing a wide range of perspectives on the most pressing issues confronting the fertility sector right now.
We are so glad to have hosted two more workshops on The IVF Experience with such kind and active participants! Natalie Silverman, from The Fertility Podcast, enthusiastically commented on the research findings we were introducing in dialogue with many others in our virtual room. We reflected upon how control can be difficult in the IVF journey, and about the benefits or challenges of sharing one’s experience with other patients during treatment. Some of our participants exchanged ideas about the resources available to fertility patients or donors when it comes to hormonal stimulation and egg pick-up, and they proposed some ways to make these experiences more bearable.
We had an interesting exchange about videos and images of embryos and how these may be received in very different ways according to when, where and how these were shared as well as personal preferences. We especially appreciated how people acknowledged each others’ points of view and how eager everyone was to hear about how research findings can contribute to improving care for patients.
These two workshops were the last of our 2021 public event series. We would like to sincerely thank everyone who has joined us for our events this year. Keep checking back on our Events page for information about our plans for 2022!
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.
On November 9th we had the pleasure to host another stimulating workshop, organised in cooperation with the Progress Educational Trust. For this online workshop we invited health professionals, researchers and fertility patient advocates to discuss the topics of evidence production and fertility treatment add-ons. This workshop was the third in a series of workshops designed for professionals (see our reports of previous workshops with the Royal College of Nursing and Progress Educational Trust).
The goal of this most recent workshop was to share ideas about: what kind of evidence can be produced in this field and how; what information is and should be available to patients in relation to the various treatments on offer; and how patients understand the evidence to support the treatments available to them.
In the first part of the workshop, Manuela Perrotta presented significant findings from our research project. She focused on the polarised debate on treatment add-ons and evidence-based medicine, by illustrating the current state of evidence available on treatment add-ons and exploring some of the reasons for lack of quality evidence. On the basis of the project findings, Manuela invited all participants to reflect upon what alternative information might be available publicly to patients interested in those treatment.
Some of the topics evoked were explored further by Sarah Armstrong, who underlined the importance of studying patients’ evaluations of complementary and add-on treatments in IVF. In the next presentation, Jack Wilkinson called into question the very definition of add-ons and resonated on how evidence is to be produced and communicated, not only in relation to whether or not specific treatments or equipment positively affect live birth rates, but also in relation to concerns about reducing chances of conception and live births.
Drawing on research data from IVF patient interviews, Josie Hamper took the (virtual) stage to introduce the different ways in which patients understand the concept of evidence in relation to their own IVF treatment journeys. Josie called for careful consideration of how patients’ personal evaluations of evidence shape their decision-making about add-ons. Josie’s talk was followed by Katy Lindermann, who stressed how, in a context of uncertainty about evidence in relation to complementary treatments and add-ons in IVF, some patients are interested in knowing whether these can produce any harm. She called for more research and information to be made public on the possibility of harm.
Among the most fruitful moments of this two-hour long workshop were the conversations that happened in breakout rooms, where all participants got the chance to express their positions, ask each other questions and react to the presentations. The option of offering patients additional information on every treatment on the HFEA website was considered a necessity, while participants discussed the pros and cons of the HFEA’s current traffic light system. Some acknowledged the challenges for health professionals in managing patients’ expectations and appreciated the need to continue having conversations with patients about the current state of add-ons.
Altogether, participants recognised the need to bring more people into these discussions, including some more of those who promote the use of add-ons. Participants broadly agreed that this would enable a more nuanced conversation about the quality of information that patients receive in order to make decisions about their own fertility journey.
This workshop was part of our public engagement event series. It was funded by a Wellcome Trust public engagement grant.
On 11 November we were happy to host the second workshop in our series The IVF Experience (see our report of the opening event here). Sarah Norcross from the Progress Educational Trust was our special guest for the second time and she succeeded in making our workshop such a welcoming and warm one. Everyone who joined us got the chance to respond to the research data that we presented, and many shared personal reflections from their own experiences. Some people spoke about what they considered to be especially important during their fertility journeys, others shared feelings or thoughts about the experience of being given embryo videos or images during their treatment.
Participants appreciated the opportunity to see how their own experience related to research data and findings and to the accounts of other participants, and some underlined how they got the chance to bring home feelings they had but hadn’t been put into words yet. It was so rewarding for us to see how our research could contribute to making some people feel more equipped to think back on their experiences, and how this event also allowed one of our participants to learn more about infertility and fertility treatment through exchanges with others.
We look forward to meeting more people at our next online workshops. Natalie Silverman will be with us on the 20th and 24th of November!
See our Events page for more details about how to sign up for the next dates.
The project team were present at this year’s Modern Family Show and the Fertility Show Online Summit. The timing of these shows presented a perfect opportunity for us to share our new animations, which you can watch on our website here.
Our booth at the Fertility Show Online Summit contained lots of details about the research project, our publications and, of course, our videos. The research team enjoyed visiting other booths as well as the many excellent seminars that were on offer across the four days. It was great to virtually ‘meet’ other show participants in the summit’s online chat.
Later in September, Manuela and I were interviewed by BBC reporter Sophie Sulehria as part of the Fertility Show’s live seminar series, which extended into the weeks following the online summit. We thoroughly enjoyed speaking to Sophie and having a conversation about fertility patients’ and professionals’ perspectives on IVF treatment add-ons.
We also screened our videos at the Modern Family Show, which took place in central London on 18 September. Unfortunately, the research team was unable to attend the show in-person, but the videos were screened on the main stage during the event for all attendees to watch.