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Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp

NCT06375811 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2025-07-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Elagolix 200 MG

Elagolix tablet

OTHER

Placebo or SOC IVF

Sugar pill manufactured to mimic Elagolix 200mg

Sponsors & Collaborators

Principal Investigators

  • Hugh Taylor, MD · Yale University

  • Heping Zhang, PhD · Yale University

  • Nanette Santoro, MD · University of Colorado, Denver

  • Emily Jungheim, MD · Northwestern University

  • Steven Young, MD, PhD · Duke University

  • Jim Segars, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-16
Primary Completion
2026-06-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375811 on ClinicalTrials.gov