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Abstract
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.
- clinical trials
- reproductive medicine
- qualitative research
Data availability statement
No data are available. No data are available. The experiences expressed during the interviews refer to sensitive and personally relevant stories; it was agreed that transcripts would not be shared with other researchers in order to preserve the anonymity of study participants.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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Data availability statement
No data are available. No data are available. The experiences expressed during the interviews refer to sensitive and personally relevant stories; it was agreed that transcripts would not be shared with other researchers in order to preserve the anonymity of study participants.
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Footnotes
Contributors RC designed the study and led on data collection, analysis and the first draft of the manuscript. DW and CP provided input into the design of the study, analysis and reviewed and approved the manuscript. AS provided input from a lay-person perspective into the design of the study, patient facing materials, results and manuscript. AP inputted into the design of the study, assisted with data collection and analysis, and reviewed and approved the final version of the manuscript. PK assisted with data analysis, and reviewed and approved the final version of the manuscript. MM inputted into the design of the study and reviewed and approved the final version of the manuscript.
Funding This study is funded by the National Institute for Health Research (NIHR) (Health Technology Assessment Programme (project reference 14/08/45)).
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and AQ5 Social Care.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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