The trouble with IVF and randomised control trials: Professional legitimation narratives on time-lapse imaging and evidence-informed care

Abstract

Focusing on the case of time-lapse imaging (TLI), this paper analyses how medical professionals negotiate the use of new ‘add-on’ fertility treatments in light of the limited evidence available. The data produced by TLI technologies is meant to help professionals identify the best embryo to be implanted. Embryo selection is essential in IVF practice for increasing pregnancy rates and reducing the negative effects of repeated failures. More than 5 years after the introduction of TLI in IVF labs, however, there has been no conclusive randomised control trial (RCT) evidence to show that the tools do indeed have a significant impact on pregnancy rates. Nonetheless, many public clinics in the UK have adopted such technologies. Consequently, our research asks: How is the use of TLI tools legitimised by professionals, in light of contradictory evidence? Focusing on 25 semi-structured staff interviews, we argue that professionals use several strategies to legitimise the use of TLI in the clinic without, however, challenging the tenets of evidence-based medicine (EBM) and the value it places on RCTs. Rather, professionals emphasise various advantages that TLI offers, including its use as a lab tool, its potential for knowledge production in embryology, and the role it plays in the management of patient expectations and course of treatment. This paper contributes to debates on the role of EBM in modern medicine and fertility care specifically – an area where this inter-relationship has been underexplored. We conclude by suggesting avenues towards a more nuanced understanding of EBM as it relates to IVF treatment and a rapidly changing biotechnology context.

The crafting of hope: Contextualising add-ons in the treatment trajectories of IVF patients

“…The data presented in this article emerge from a larger study that considered professional and patient perspectives on technological innovations in IVF ( Perrotta and Geampana, 2020 ). This paper focuses specifically on findings from interviews with 42 patient participants, including 34 women going through IVF, seven male partners and one female partner.…”

“…Some private clinics do not charge for add-ons that are included in their standard packages. NHS clinics also often include some of the most established add-ons in their all-inclusive treatment ( Perrotta and Geampana, 2020 ), which can be either publicly or privately funded at costs that are similar to basic packages offered by some private clinics. The inclusion of add-ons in these cases is considered less controversial as patients are not charged extra for them, yet considering the lack of public funding in this sector, some consider it unethical for the NHS to invest in unproven treatments.…”

Enacting evidence‐based medicine in fertility care: Tensions between commercialisation and knowledge standardisation

“…The controversy has gained significant media attention in the UK, including a 2016 BBC Panorama documentary entitled 'Inside Britain's Fertility Business' portraying private IVF clinics as taking financial advantage of vulnerable patients. Similarly, both in the medical and social science literature (Harper et al, 2017;Van de Wiel, 2019) the proliferation of add-ons is presented as a phenomenon that is due to the high-privatisation of the sector, regardless of the fact that several add-ons are widely used in NHS (public) clinics too (Perrotta & Geampana, 2020).…”

“…Recent social science research has witnessed an increasing call for a more inclusive approach to evidence, noting that what is highly-rated in the dominant EBM model offers only extremely decontextualised information (Trnka & Stöckelová, 2019). However, the tenets of the EBM hierarchy of evidence have been institutionalised, including for fertility care (Perrotta & Geampana, 2020).…”

Experiences of trial participants and site staff of participating in and running a large randomised trial within fertility (the endometrial scratch trial): a qualitative interview study

“…This may have been exacerbated by the time-sensitive nature of fertility treatment and the desire for a positive outcome; both clinicians and patients have been reported to feel the need to improve the outcomes of treatment immediately following a failed treatment cycle. 22…”