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

OBJECTIVES: To explore the experiences of endometrial scratch (ES) trial participants and site staff of trial recruitment and participation, in order to improve the experience of participants in future trials. DESIGN: Qualitative study of a subset of participants in the ES randomised controlled trial and a subset of trial site staff. SETTING: A purposeful sample of 9 of the 16 UK Fertility Units that participated in the trial. PARTICIPANTS: A purposeful sample of 27 trial participants and 7 site staff. RESULTS: Participants were largely happy with the recruitment practices, however, some were overwhelmed with the amount of information received. Interviewees had positive preconceptions regarding the possible effect of the ES on the outcome of their in vitro fertilisation (IVF) cycle, which often originated from their own internet research and seemed to be exacerbated by how site staff described the intervention. Some participants appeared to not understand that receiving the ES could potentially reduce their chances of a successful IVF outcome. Those randomised to the control arm discussed feeling discontent; site staff developed mechanisms of dealing with this. CONCLUSIONS: A lack of equipoise in both study participants and the recruiting site staff led to trial participants having positive preconceptions of the potential impact of the ES on their upcoming IVF cycle. Trial participants may not have understood the potential harms of participating in a randomised trial. The trial information sheet did not clearly state this; further research should assess how such information should be presented to potential participants, to proportionately present the level of risk, but to not unduly discourage participation. The amount of information fertility patients require about a research study should also be investigated, in order to avoid participants feeling overwhelmed by the amount of information they receive prior to starting IVF. TRIAL REGISTRATION NUMBER: ISRCTN23800982.