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

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

• Infertility
• Endometriosis

Interventions

DRUG

Elagolix 200 MG

Elagolix tablet

OTHER

Placebo or SOC IVF

Sugar pill manufactured to mimic Elagolix 200mg

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Colorado, Denver

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• David Weinberg, PhD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• 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

• Abisola Tepede, PharmD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

2022-03-15

Primary Completion

2025-05-02

Completion

2025-05-02

FDA Drug

Yes

Countries

• United States

Study Locations