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

Reprod Sci. 2022 Feb;29(2):620-626. doi: 10.1007/s43032-021-00705-0. Epub 2021 Aug 6.

Abstract

The Pre-IVF Treatment with a GnRH Antagonist in Women with Endometriosis (PREGnant) Trial (clinicaltrials.gov no. NCT04173169) was designed to test the hypothesis that 60-day pre-treatment with an oral GnRH antagonist in women with documented endometriosis and planning an IVF cycle will result in a superior live birth rate to placebo. Eight hundred fourteen women are required from 4 national sites. To determine the feasibility of using an electronic medical record (EMR)-based strategy to recruit 204 participants at the Colorado site, we conducted a survey of women within the UCHealth system. Eligible women, identified using relevant ICD-10 codes, were invited to complete a 6-question survey to assess planned utilization of IVF, potential interest in participation, and whether delays in treatment due to COVID-19 would influence their decision to participate. Of 6354 age-eligible women with an endometriosis diagnosis, 421 had a concurrent infertility diagnosis. After eliminating duplicates, 212 were emailed a survey; 76 (36%) responded, 6 of whom reported no endometriosis diagnosis. Of the remaining 70, 29 (41%) were planning fertility treatment; only 19 planned IVF. All 19 expressed interest in participation. COVID-19 delays in treatment were not considered as a factor affecting participation by 8/19; the remaining 11 felt that it would "somewhat" affect their decision. None reported that they would not consider participation because of COVID-19. EMR-based recruitment for an endometriosis clinical trial is feasible although the overall yield of participants is low. Delays in treatment due to COVID-19 did not appear to overly influence potential recruitment.

Keywords: Endometriosis; GnRH antagonist; In vitro fertilization; Infertility.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • COVID-19*
  • Choice Behavior
  • Double-Blind Method
  • Electronic Health Records
  • Endometriosis / diagnosis
  • Endometriosis / physiopathology
  • Endometriosis / therapy*
  • Female
  • Fertility Agents, Female / adverse effects
  • Fertility Agents, Female / therapeutic use*
  • Fertilization in Vitro*
  • Gonadotropin-Releasing Hormone / antagonists & inhibitors
  • Health Knowledge, Attitudes, Practice*
  • Hormone Antagonists / adverse effects
  • Hormone Antagonists / therapeutic use*
  • Humans
  • Infertility, Female / diagnosis
  • Infertility, Female / physiopathology
  • Infertility, Female / therapy*
  • Live Birth
  • Patient Selection*
  • Pregnancy
  • Pregnancy Rate
  • Research Subjects / psychology*
  • Treatment Outcome
  • United States
  • Young Adult

Substances

  • Fertility Agents, Female
  • Hormone Antagonists
  • Gonadotropin-Releasing Hormone

Associated data

  • ClinicalTrials.gov/NCT04173169