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NCT06375811 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Infertility and Endometriosis, sponsored by Yale University.

Recruiting
Registry status
Phase 3
Development phase
297
Enrollment target
5
Study locations

NCT06375811 is a Phase 3 study of Infertility and Endometriosis that is actively recruiting participants, run by Yale University. The registered enrollment target is 297 participants, below the 7,585-participant average among 74 other Infertility trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT06375811, a Phase 3 study of Infertility and Endometriosis, is actively recruiting participants, sponsored by Yale University.

RECRUITING
Registry status
Phase 3
Development phase
297 participants
Enrollment target
5
Study locations

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.

Interventions

  • DRUG Elagolix 200 MG
  • OTHER Placebo or SOC IVF

Study Locations (5)

Colorado

  • University of Colorado Department of Obstetrics & Gynecology - Aurora

Connecticut

  • Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences - New Haven

Illinois

  • Northwestern University Department of Obstetrics and Gynecology - Chicago

Maryland

  • Johns Hopkins, Division of Reproductive Science and Women's Health Research - Baltimore

North Carolina

  • Duke Fertility - Morrisville

Trial Details

FieldValue
Enrollment Target 297 participants
Start Date 2024-03-16
Est. Completion 2026-09-30
Phase Phase 3

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT06375811

The ClinicalTrials.gov registry entry for NCT06375811 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 297 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,585-participant average among 74 other Infertility trials with a reported enrollment target (96% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Infertility appearing as the primary indexed condition, and to 2 interventions - of which Elagolix 200 MG is the first listed.

NCT06375811 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Colorado, Connecticut, Illinois.

Frequently Asked Questions

What is clinical trial NCT06375811 about?

NCT06375811 is a clinical study titled "Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp". 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...

What is the current status of trial NCT06375811?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 297 participants. The study started on 2024-03-16. Estimated completion is 2026-09-30.

What conditions does trial NCT06375811 study?

This clinical trial studies the following conditions: Infertility, Endometriosis.

What interventions are being tested in trial NCT06375811?

The interventions under investigation include: Elagolix 200 MG (DRUG), Placebo or SOC IVF (OTHER).

Who is sponsoring clinical trial NCT06375811?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06375811 being conducted?

This trial has 5 study locations across Colorado, Connecticut, Illinois, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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