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NCT04173169 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Yale University.

Completed
Registry status
Phase 3
Development phase
103
Enrollment target

NCT04173169: Completed Phase 3 study, sponsored by Yale University.

NCT04173169 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 103 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04173169, a Phase 3 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 3
Development phase
103 participants
Enrollment target

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.

Primary Outcome

The percentage of the number of participants with a live birth at ≥24 weeks of gestation out of those who were enrolled in the study

Interventions

  • DRUG Elagolix 200 MG
  • OTHER Placebo or SOC IVF

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2022-03-15
Est. Completion 2025-05-02
Phase Phase 3
Yale University

1,492 total trials

What the finished NCT04173169 record still lists

NCT04173169 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which Elagolix 200 MG is the first listed.

NCT04173169 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04173169 about?

NCT04173169 is a clinical study titled "Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis". 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 NCT04173169?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2022-03-15. Estimated completion is 2025-05-02.

What interventions are being tested in trial NCT04173169?

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

Who is sponsoring clinical trial NCT04173169?

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

How this trial's enrollment target compares

Where NCT04173169's enrollment target sits among peer trials

103 1674th of 2000 higher than 325 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04173169, the US trial registry maintained by the National Library of Medicine. NCT04173169 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.