Tag: Reproductive technology

Final public engagement event report: Panel on IVF add-ons

On 1st February 2022

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.

Open event: A global perspective on fertility treatment add-ons

By Josie Hamper

On 19th January 2022

In Events

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.

PET’s annual conference: The current state and regulation of the fertility sector

By Josie Hamper

On 13th December 2021

In Conferences, News

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.

Women’s Health Strategy consultation response

By Josie Hamper

On 28th September 2021

In News, Topical

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.

Re.conceive + Remaking the Human Body

By Josie Hamper

On 3rd September 2021

In Guest post, News

At the beginning of May we were delighted to spend an afternoon on Zoom with visual artist Sally Butcher, who is currently working on her Arts Council England funded project re.conceive. Sally approached us a while back to explore some of the synergies between our projects, which in different ways explore how reproduction, fertility and (non-)reproductive bodies are visualised or, sometimes, become invisible. Sally very generously shared some of her work-in-progress with us and we shared details about our research process and findings.

Each member of the research team was able to spend some time with Sally individually, and I include our reflections in our own words below.

Giulia: Sally’s work has inspired our conversation around reproduction in its different forms. We have especially discussed the relationship between medical knowledge, technologies and tools to visualise reproductive body parts or phenomena, and embodied experiences of them. We talked about the role of visual experiences in the construction of dominant narratives of gendered reproductive lives, and about the visibility and invisibility of specific reproductive experiences (for example infertility, miscarriages, abortion). We explored the notions of common and uncommon, known and unknown, expected and unexpected, we discussed how individual experiences relate to standardised measures and protocols and how people adjust and react to these, especially when these intersect with other medical, legal and geographical infrastructures (for example in the context of transnational reproductive travels).

Sally Butcher, ***Infertile Platitudes of Embodied Emptiness***, Sonogram 7/9, Archival Inkjet Digitised Monoprint (2020). Used here with permission from the artist.

Manuela: Among the many things we talked about, Sally and I had an interesting conversation regarding some of her work-in-progress – in my interpretation, an inspiring visualisation of the current developments in the field of embryology. Sally’s representation of sets of data embedded within an image of an embryo captured the current turn in embryology, by highlighting visually the novel and increasing use of data-driven algorithms in this field. In our research, analysing the case of Time-lapse incubators and their incorporated algorithms, we have investigated how new knowledge about embryos is generated in the complex interactions between professionals and machines. Although the use of algorithms has the potential to release unknown biological information on embryos (and therefore reveal their hidden secrets), algorithms do not simply add medical and reproductive knowledge as they require human input and therefore still rely on professional expertise.

Sally Butcher, *Human Algorithm V*, pencil and pen on paper (2021). Used here with permission from the artist.

Josie: During our conversation, Sally and I found many shared interests: for instance in how themes of absence and presence, and proximity and distance, shape ideas about reproduction as well as experiences of infertility. Being a geographer (academically and at heart!), I was drawn to how the body exterior and interior are ‘mapped’ in some of Sally’s work. We talked about the role of measurements, ordering, boundaries and boundary-making in relation to how reproductive processes are visualised and described. We also talked about the intrigue and mystery of magnifying or looking inside things.

Sally’s work also drew my attention to all the other kinds of imagery that fertility patients encounter before or during their IVF treatment. The focus of our research is on images and videos of embryos, which are exterior to the body or in vitro. But fertility patients often encounter a whole range of other visualising techniques that allow them to see inside their bodies. Ultrasound scans and dye tests, for instance, are routinely used to medically investigate female reproductive organs and check that these appear to be functioning ‘normally’. Ways of visualising bodies and embryos have (personal and political) implications for how infertility is seen and known, and therefore very real consequences for patients’ treatment experiences and trajectories.

Sally Butcher, **Sub-Maternal Exhaustion During a Pandemic**, Archival Photograph, egg, ink and hand gel (2020). Used here with permission from the artist.

Sally: My conversations with the Remaking the Human Body team have been invaluable in my research project. As a visual artist, Re.conceive was driven by the invisibility of Infertility within the new wave of maternal visual arts, where, as in society at large, infertility still remains mostly hidden and shrouded in silence. My project aims to explore and visually theorise the transformational process of ‘becoming’ a (M)Other, challenging traditional reproduction to reconceive a form of sub-maternal.

My meetings with Giulia, Josie and Manuela helped thoroughly contextualise my thinking, aiding my understanding of how infertility connects with the broader narrative of reproduction, as well as giving me greater insight into the scientific procedures within embryology and new practices with AI, and drew my focus onto patient interpretation of these new technologies. It especially moved my thinking toward the visual and verbal languages used within infertility. As a cultural researcher, I am drawn to the rhetoric of medical terminology, weighted in ‘success’ and ‘failure’, aimed at potential ‘geriatric mothers’ with ‘inhospitable uteruses’, and how this may sit alongside hidden personal testimonies, confessional spaces of the coded #TTC online community, or conversations with family and friends where it so often generates a real sense of unease. As an artist, I try to use a feminist gaze to challenge institutionalised power within visual tropes of medical and commercial imagery of infertility. These meetings enlightened me as to how much power we place in these visuals and how these become naturalised into our knowledges of reproduction, with narratives of the embryo constructed from the encounters we have with these visuals. The immediate resonances I felt between my own practice and the fantastic work being done by this team, has encouraged me to continue using this imagery, exploring its symbolism alongside the power of the maternal imagination.

Patients and IVF add on treatments

By Josie Hamper

On 15th January 2019

In Topical

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 9^th 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.

Why we go to the Fertility Show

By Josie Hamper

On 8th November 2018

In Events

For the last couple of years, the research team has attended the annual Fertility Show in London. Now in its tenth year of existence, the Fertility Show has emerged as a key event for people who are interested in learning more about family making, infertility and the world of fertility treatment. This year, which also marks the 40th anniversary of IVF, the show hosted over 100 exhibitors from the UK and beyond, over 50 seminars, and thousands of visitors over the course of the weekend. All sorts of exhibitors were present; ranging from clinicians, doctors and practitioners who specialise in all aspects of reproductive health and medicine, advice groups, trusts and charities, financial and legal consultants, lifestyle and nutrition advisors, holistic therapists, acupuncturists, and many more.

For the research team, being at the Fertility Show is a chance to learn about technological innovations that are taking place in the world of IVF as well as how these are presented to people who are considering this type of fertility procedure. In other words, the show offers an insight into how professionals communicate their expertise to the non-expert ‘general public’, which can tell us something important about how science and technology ‘operate’ in the world. In practice, we divided ourselves across the two days to attend seminars, explore the stands, talk to fertility professionals and collect written material, such as flyers and information booklets, to add to our growing archive.

While the quantity of printed material can be overwhelming, as a collection it tells us a lot about how the possibilities and technologies of conception are dynamic and continuously evolving. Of special interest to me is how imagery and visual aids are used to communicate information. This includes medical illustrations, diagrams, charts, ultrasound imagery and product images, as well as all the other photographs that are used to frame information in very particular (and sometimes quite peculiar) ways. The most obvious observation with regards to the latter is the proliferation of pregnancy images, which often focus on the ‘baby bump’, and pictures of the wished-for child. Broadening out we might think about how this visual material presents male and female reproductive bodies differently or about the assumptions that are made about what constitutes a ‘family’ in this context.

Talking to people at the show is also an opportunity to tell them about our research, which often involves challenging ourselves to effectively explain the value of social science in an otherwise heavily medicalised field. This is not an unfamiliar contention for researchers who employ qualitative methods, such as interviews, visual analysis and ethnographic observation, as opposed to research methods that are associated with the ‘hard sciences’, which often involve quantification.

Needless to say, medical and scientific research is absolutely fundamental to the advancement of effective and safe fertility treatment. But as social scientists we are equipped with tools that allow us to offer differently nuanced pictures of the everyday practices through which scientific knowledge is made, and how these processes of knowledge production and translation are regularly tied up with social, cultural, relational and emotional dimensions of lived experience that are rooted in particular contexts. This kind of insight is particularly important as new technologies are introduced and negotiated by both IVF professionals and patients – what do these technologies mean to people and how are they made sense of?

In addition to exploring and learning at this year’s show, being in this environment provokes considerations that should be at the forefront of any research project: about what our research can offer and how to communicate its value to others.