Willingness of Women with Endometriosis Planning to Undergo IVF to Participate in a Randomized Clinical Trial and the Effects of the COVID-19 Pandemic on Potential Participation
A survey found that electronic medical record-based recruitment for a GnRH antagonist trial in women with endometriosis is feasible, though low in yield, with COVID-19 delays not significantly impacting participation interest.
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The study investigated feasibility of recruiting women from an EMR-based approach for the PREGnant randomized trial, which tests whether 60 days of pre-IVF elagolix versus placebo improves live birth in women with documented endometriosis planning IVF, and assessed how COVID-19 treatment delays might affect willingness. Using UCHealth EPIC/REDCap, the authors identified 212 eligible women with endometriosis and concurrent infertility, emailed a six-question survey, and received responses from 76 (36%); after exclusions, 70 reported endometriosis and 29 planned fertility treatment, with 19 planning IVF, all 19 expressing interest in participation. COVID-19 delays were not considered by 8/19, while 11 reported they would “somewhat” affect their decision; none reported they would not consider participation due to COVID-19. A key limitation is the low overall recruitment yield driven by the EMR-to-survey response rate and the subset planning IVF. This paper is centrally about endometriosis — it evaluates EMR-based recruitment and participation willingness for a trial of elagolix pre-treatment in women with endometriosis planning IVF, including COVID-19 effects on enrollment interest.
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