We are delighted to announce our upcoming webinar, marking the conclusion of the Remaking the Human Body project (2016/2023). The webinar is scheduled for October 4th, from 3 pm to 5 pm BST. Please save the date and reserve your spot via Eventbrite.
3.00 – 3.10 Welcome
3.10 – 3.30 Time-lapse Imaging and the Add-ons Debate: An Overview of the Remaking the Human Body Project – Manuela Perrotta, Queen Mary University of London
3.30 – 3.50 Evidence Challenges and Professional Views on New Treatments in IVF – Alina Geampana, Durham University
3.50 – 4.10 Patients’ Perspectives on IVF Add-ons and Evidence – Josie Hamper, University of Oxford
4.10 – 4.30 Round Table: Experiences of Public Engagement
Giulia Zanini, Ca’ Foscari University of Venice
Manuela Perrotta, Queen Mary University of London
Alina Geampana, Durham University
Josie Hamper, University of Oxford
4.30 – 5.00 Q&A and Closing Remarks, chair – Marcin Smietana, Queen Mary University of London / University of Cambridge
This event showcases the research conducted by Dr Manuela Perrotta and the study team as part of the Wellcome Trust-funded grant titled “Remaking the Human Body: Biomedical Imaging Technologies, Professional and Lay Visions” (Wellcome Trust Investigator Award, 2016-2023). Additionally, we will discuss the research team’s experiences within a related program of public engagement, funded by the Wellcome Trust (Wellcome Trust Research Enrichment, 2019-2023).
The Remaking the Human Body project aimed to investigate the integration of new visual technologies into In Vitro Fertilization (IVF), with a particular focus on time-lapse imaging. While our primary objective was initially to examine the relationships between these new visual technologies and professional and lay visions, a sudden shift in the public and medical discourse surrounding “add-ons”, including time-lapse imaging, necessitated an exploration of an additional research direction. The term “add-ons” is commonly used to describe costly supplementary investigations and interventions offered to patients despite a lack of sufficient evidence regarding their safety and effectiveness.
In this webinar we will provide an overview of the study and our findings through a series of short presentations by the Remaking the Human Body study team. The webinar will explore time-lapse imaging, in addition to addressing broader debates about add-ons. We hope that this event and our findings will stimulate discussions about the uncertainties in medical knowledge and the experiences of infertility among patients, as well as the related implications for policy and practice.
A new consultation document addresses how time-lapse videos of embryo development are shared with IVF patients. This is a work-in-progress and we are seeking feedback on the document until July 5th, 2023.
You can find the consultation document in the Open Consultationpage. To contribute to this consultation, please email firstname.lastname@example.org or use the contact details at the end of the consultation document.
This consultation builds on a workshop that took place in January 2023, organised in collaboration with the Progress Educational Trust. Participants at this workshop included a diverse range of professionals from the field of assisted reproduction.
Drawing on findings from interviews, the focus of the workshop was on how IVF patients feel about receiving time-lapse videos of embryo development during IVF treatment. In particular, we focused on when, where and how these videos are shared and received. Workshop participants were invited to reflect on their own practices of sharing time-lapse videos with their patients.
This week, I have been attending the ESHRE conference online. Despite my fervent hope, the long-awaited moment to return to in-person conferences has not transpired and I had to revert to virtual participation. Being able to attend remotely was, unexpectedly, a great opportunity. The conference platform was highly effective, and I could follow all the presentations undisturbed, while sitting comfortably at my desk sipping coffee.
With our poster (you can find the abstract here) we wanted to shed light on an overlooked issue related to sharing Time-Lapse (TL) videos with patients. As our last published work shows, patients often watch the videos of their embryos for the first time at home, without the support of an embryologist to answer any questions that might arise. Even if patients are asked whether they want to receive embryo videos, what these videos show is not very clear to them, and they often do not know what to expect. As patients often associated embryo videos with a potential future baby, watching these videos without an appropriate explanation can cause confusion and potential distress. This potential is even higher when embryo videos are shared just after the transfer and before patients are even able to take a pregnancy test. To improve patients’ experience, we urge professionals to consider further how, where and when these videos are shared with patients.
I was very happy to see that our suggestion was welcomed by one of the main experts and author of the two Cochrane reviews on TL, Sarah Armstrong. In her talk, opening the session dedicated to “The current state of Time-Lapse technology”, she offered an overview of quantitative and qualitative studies available currently on TL. Although the focus of her talk was discussing current evidence of its clinical benefit, she also mentioned our work on patients’ experiences of receiving and watching embryos, opening up for a discussion on whether, when and how clinics should share embryo videos with their patients.
In this and another presentation, Sarah also shared the highlights of the VALUE study, an international qualitative study exploring patients’, embryologists’, and clinicians’ decisions to use non-evidence-based treatment ‘add-ons’. The early results of this study show some significant overlap with the results of our project. For instance, as we discussed in one of our previous publications, Sarah noticed how the decisions to use add-ons should be seen in the context of hope for both patients and professionals. Applying the current (missing) evidence is challenging for both professionals (as we have also discussed here) and patients (as we discuss in another article currently under review). Finally, she argued that patients don’t want to be denied add-ons but want autonomy in the form of informed consent. I really look forward to reading the detail of the VALUE study results.
The discussion on the lack of evidence on TL efficiency was not limited to these talks, as Dorit Kieslinger presented the results of the last RCT on TL: The SelecTIMO study. This study, including 1,731 women, investigated embryo culture in the Geri+ incubator and the Eeva® Test algorithm. Their results show that the use of TL, with or without algorithm-based selection, does not improve (cumulative) ongoing pregnancy and live birth rates and therefore its widespread use to increase success rate should be questioned. Despite the results, the discussion after the presentations followed the same logics we showed in our previous research. The audience questioned the evidence (results apply only to the incubator and algorithm examined, others could work better) and the need itself for TL to prove its efficacy in terms of increasing success rates (we use it because it’s a great piece of lab equipment). This discussion goes back to the origin of the problem, which for many does not seem to be if there is evidence to support the ongoing use of these tools, but rather that patients are charged for tools that might not increase their chances of having a baby. As a participant from Denmark commented, TL is very widespread among Danish labs but patients are not charged for its use, and nobody talks about add-ons.
It is interesting to see how the use of artificial intelligence (AI) is becoming more widespread in the field, without discussion regarding the evidence supporting it. A discussion in the General Assemby highlighted how all the current publications on the topic of AI, do not offer any information on the data, the data points measured, or the content of the algorithms, justified in terms of the defence of intellectual property. It is perhaps surprising that here, unlike in the debate on add-ons, the question of evidence seems to have been overlooked.
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.
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.