ObjectivesIn vitro fertilisation (IVF) add-ons are additional procedures offered alongside an IVF cycle with the aim of improving live birth rates. They are controversial because of the paucity of evidence to support their efficacy and safety, alongside the additional financial cost they often pose to patients. Despite this, they are popular. However, there is limited qualitative research regarding their use. The aims of the VALUE Study were to understand the decision-making process surrounding using or recommending add-ons; report sources of information for add-ons; and explore concerns for safety and effectiveness when considering their use.Design‘VALUE’ is a qualitative semistructured interview study using inductive thematic analysis of anonymised transcriptions.SettingParticipants were recruited from a broad geographical spread across the UK and Australia from public and private clinical settings.ParticipantsPatients (n=25) and health professionals (embryologists (n=25) and clinicians (n=24)) were interviewed. A purposive sampling strategy was undertaken. The sampling framework included people having state-subsidised and private cycles, professionals working in public and private sectors, geographical location and professionals of all grades.ResultsPatients often made decisions about add-ons based on hope, minimising considerations of safety, efficacy or cost, whereas professionals sought the best outcomes for their patients and wanted to avoid them wasting their money. The driving forces behind add-on use differed: for patients, a professional opinion was the most influential reason, whereas for professionals, it was seen as patient driven. For both groups, applying the available evidence to individual circumstances was very challenging, especially in the sphere of IVF medicine, where the stakes are high.ConclusionsThere is scope to build on the quality of the discourse between patients and professionals. Patients describe valuing their autonomy with add-ons, but for professionals, undertaking informed consent will be critical, no matter where they sit on the spectrum regarding add-ons.Trial registrationosf.io/vnyb9.

Study question Why do patients, clinicians and embryologists opt to use IVF add-ons in fertility treatment? Summary answer Add-ons offer options, hope and control in a desperate situation. The perceived drivers differ between patients and professionals; however, both feel add-ons offer bespoke care. What is known already Evidence that add-ons offer clinical advantages for the outcomes of IVF is lacking or insufficient. However, they remain popular in the UK and Australia, with over three-quarters of couples opting to use them. Professionals, clinical societies, and the media have latched onto the ethical aspects of offering non-evidence-based add-ons, often provided at an additional cost to vulnerable patients. Conversely, it has also been suggested that patients are driving add-on use. The VALUE study is the first large qualitative study to include both patients and professionals that explores the drivers behind their use, and how the existing evidence is weighed up. Study design, size, duration VALUE was a multinational semi-structured interview study in the UK and Australia. The interview schedule was reached through extensive patient and public involvement. Between January and May 2021, recruitment took place via social media advertisement, email invitation from professional societies, and snowballing. A purposive sampling strategy was planned; all eligible participants (25 patients, 25 embryologists, and 24 clinicians) were interviewed via recorded teleconference. Anonymised verbatim transcripts were analysed iteratively, and themes developed inductively. Participants/materials, setting, methods Patient and professional transcripts were coded separately using the software DedooseTM Two separate thematic analyses followed. An inductive approach to analysis was adopted, whereby themes emerged from the data, opposed to constructing a pre-conceived coding scheme. Codes were combined into broader themes, and sub-themes, which were discussed, debated, and named. The wider research team then commented upon and debated the themes and sub-themes, which were settled upon by consensus. Main results and the role of chance Thematic analysis of patient interviews identified five themes: ‘vulnerability’; ‘power of the trusted professional opinion’; ‘role of previous experience’; ‘acceptability of add-on’; and ‘the evidence doesn’t apply to me’. The professional interviews identified five themes: ‘Treating desperation’; ‘tensions within evidence-based practice’; ‘success, not profits’; ‘the patient shopper’; and ‘potential for harm’. Analysis identified that that people undergoing IVF are vulnerable and opting for non-evidence-based treatments at additional cost because of a sense of desperation following unsuccessful cycles. For patients, utilising add-ons lends hope and a sense of control, with considerations of safety and efficacy being ranked lower than hope. For professionals, add-ons are reasonable given the absence of anything else to add, and allows patients the opportunity to exhaust every avenue. At odds with one-another are the themes regarding who is driving add-on use. Patients describe the power of a professional recommendation, believing it to be in their best interest. For professionals, it’s the patients who research and request add-ons, and failing to offer them risks losing patients. The tension between evidence and bespoke care was evident across both analyses, with testimonies being particularly powerful for patients, and for professionals, a belief that add-ons are helpful in the right context. Limitations, reasons for caution The VALUE study has captured patients and professionals who have volunteered to talk about this particularly contentious area of medicine. Participants are likely to be a motivated group of individuals who may potentially represent those with strong views regarding add-ons. Wider implications of the findings The theme of desperation runs through VALUE’s analyses and whilst we did find that patients drive add-on use, professional opinion for or against add-ons was powerful. Patients want autonomy, but only in the context of informed consent. Trial registration number https://osf.io/he7tn/

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Background Time-lapse technology for the observation of embryos is not new, having been first described in 1930 by Dr WH Lewis using rabbit embryos. However, the use of software (using artificial intelligence and deep learning) linked to known clinical outcomes theoretically helps the embryologist select the ‘best’ embryo for embryo transfer. Time-lapse also reduces the need to manually handle embryos and is hypothesised would reduce biases due to interobserver variation and improve clinical outcomes. Whilst the technology may help improve laboratory workflow, the quantitative evidence is less clear. This raises the ethical question about charging extra for a technology which does not improve patient outcome. In offering time-lapse, professionals have argued that it responds to patient demand and the need to be seen as ‘cutting edge’. However, the patient perspective for using time-lapse has, until recently, been largely unexplored. Methods This presentation relies on three sources of evidence: (i) Systematic reviews of randomised controlled trials (RCTs) and newly published RCTs not yet incorporated into systematic reviews; (ii) Qualitative studies concerning the consideration or use of time-lapse in those undergoing IVF; and (iii) A qualitative study (VALUE) of patient professional views regarding time-lapse, amongst other add-ons. Results The latest Cochrane systematic review undertook three comparisons to best establish where the potential advantage of time-lapse may lie: (i) undisturbed culture; (ii) the use of software to select the embryo to replace; or (iii) a combination of both stable culture and software. For all outcomes assessed, including crucially livebirth and miscarriage, there was no good evidence to show that time-lapse was any more or less effective than conventional methods of embryo incubation. These findings are supported by another systematic review by Chen et al (2017). A large RCT (TILT) is currently underway and will be the largest RCT to examine the clinical effectiveness and safety of time-lapse. TILT is expected to complete recruitment soon. The VALUE study is an international qualitative semi-structured interview study of patients, embryologists, and clinicians to explore the reasons behind the decisions to use non-evidence-based treatment ‘add-ons’ alongside an IVF cycle. Over half of patient participants interviewed opted to use time-lapse. Inductive thematic analysis revealed five key themes for patients: (i) ‘vulnerability’; (ii) ‘power of the trusted professional opinion’; (iii) ‘role of previous experience’; (iv) ‘acceptability of add-on’; and (v) ‘the evidence doesn’t apply to me’. The analysis of the professional participants’ interviews revealed five themes, some of which mirror the patient themes: (i) ‘treating desperation’; (ii) ‘the patient shopper’; (iii) ‘success not profits’; (iv) ‘potential for harm’; and (v) ‘tensions within evidence-based practice’. Discussion Time-lapse has been adopted widely across fertility clinics globally, and with good reason. It brings efficiencies and convenience for embryologists by allowing them to observe embryos remotely. However, the highest quality evidence does not support the notion that it improves livebirth or reduces miscarriage rates. Qualitative research shows that patients can make choices about add-ons that can leave them in debt due to desperation and the desire to look for hope in an otherwise uncontrollable situation. Professionals acknowledge this, and in their desire to achieve a pregnancy, they sometimes look to add-ons such as time-lapse as a ‘why not’ when previous cycles have failed. Patients describe how they do not want to be denied time-lapse but want it in the context of informed consent. This must include being open about the paucity of evidence to support its effectiveness at this stage.