VALUE study: a protocol for a qualitative semi-structured interview study of IVF add-ons use by patients, clinicians and embryologists in the UK and Australia

Abstract

IntroductionFor couples undergoing assisted reproduction, a plethora of adjuncts are available; these are known as ‘add-ons’. Most add-ons are not supported by good quality randomised trial evidence of efficacy, with some proven to be ineffective. However, estimates suggest that over 70% of fertility clinics provide at least one add-on, often at extra cost to the patient. This study has three aims. First, to undertake a survey of in vitro fertilisation (IVF) clinics in the UK to ascertain which add-ons are being offered and at what cost. Second, to undertake qualitative semi-structured interviews of patients, clinicians and embryologists, to explore their opinions and beliefs surrounding add-ons. Third, to review the interpretation of the Human Fertilisation and Embryology Authority traffic light system, to better understand the information required by IVF patients, clinicians and embryologists when making decisions about add-ons.Methods and analysisAll UK IVF clinics will be contacted by email and invited to complete an online survey. The survey will ask them which add-ons they offer, at what cost per cycle and how information is shared with patients. Semi-structured interviews will be conducted in the UK and Australia with three groups of participants: (i) fertility patients; (ii) clinicians and (iii) embryologists. Participants for the interviews will be recruited via social media channels, website adverts, email and snowball sampling. Up to 20 participants will be recruited for each group in each country. Following an online consent process, interviews will be conducted via video-conferencing software, transcribed verbatim and data subjected to inductive thematic analysis.Ethics and disseminationEthical approval has been granted by the Universities of Sheffield, Bath Spa and Melbourne. Findings will be published in a peer-reviewed journal and disseminated to regulatory bodies in the UK and Australia. A lay summary of findings will be shared via Fertility Network, UK.

Patient and professional perspectives about using in vitro fertilisation add-ons in the UK and Australia: a qualitative study

“…The protocol for the VALUE Study was published prospectively. 20 Inclusion criteria for patient participants were: adult women, men or couples (18+ years of age); who had undergone IVF or intracytoplasmic sperm injection (ICSI) in the past 2 years (any number of cycles); publicly funded (National Health Service (NHS) funded in the UK, or Medicare in Australia) or privately funded; using either autologous oocytes and sperm, or donor oocytes and sperm; and who had considered using, or had used, one or more add-ons as part of their treatment. Inclusion criteria for clinicians were registered doctors involved in the care of patients or couples undergoing assisted reproduction.…”

‘It all depends on why it’s red’: qualitative interviews exploring patient and professional views of a traffic light system for in vitro fertilisation add-ons

“…We followed the methodology outlined in our published protocol ( Armstrong et al 2021 ). The interviews were part of a parent project exploring the motivations and barriers to IVF add-on use (Armstrong et al , under review).…”

“…We undertook extensive patient and professional involvement with IVF clinicians ( n = 4), embryologists ( n = 4), and patients ( n = 5) who provided input into the study design including the development of the interview schedule, plain language summary, research advertisements, study website, and recruitment strategy ( Armstrong et al 2021 ). This feedback resulted in several changes to the study design including splitting the patient interview into two separate sessions.…”