CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 103 enrolled / 103 target
Drug / intervention
Elagolix 200 MG +1 moredrug
Likely dose
Elagolix 200 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04173169
NCT04173169Phase 3CompletedOn Track (2.0/mo)Completion was 13mo ago
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Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis - A Prospective Clinical Trial

Yale University·interventional·Posted Nov 21, 2019·Updated Jun 12, 2026

In Brief

A Phase 3 clinical trial evaluating Elagolix 200 MG and Placebo or SOC IVF for Infertility and Endometriosis. Completed, enrolled 103 participants across 5 sites.

Detailed Summary

A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility, Endometriosis
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver, Northwestern University, University of North Carolina

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 21, 2019
Enrollment StartMar 15, 2022
Primary CompletionMay 2, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.6 years ago

Arms & Interventions

Pre-IVF Treatment with 60 day course of oral GnRH antagonistactive_comparator

For those who agree to be randomized, subjects will be randomized to elagolix 200mg BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day. This arm will also include participants who do not want to be randomized while choose elagolix.

Drug: Elagolix 200 MG
Pre-IVF Treatment with 60 day course of Placebo or SOC IVFother

For those who agree to be randomized, subjects will be randomized to placebo, BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day. This arm will also include participants who want to continue their ongoing or planned IVF and follow standard of care (SOC) (SOC IVF) if they do not want to delay the IVF procedure.

Other: Placebo or SOC IVF

Interventions

Elagolix 200 MGdrug

Elagolix tablet

Placebo or SOC IVFother

Sugar pill manufactured to mimic Elagolix 200mg