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NCT04445025 · ClinicalTrials.gov registry record · Early Phase 1

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis

A Early Phase 1 study, sponsored by Colorado Center for Reproductive Medicine.

Completed
Registry status
Early Phase 1
Development phase
30
Enrollment target

NCT04445025: Completed Early Phase 1 study, sponsored by Colorado Center for Reproductive Medicine.

NCT04445025 is a Early Phase 1 study that has completed, run by Colorado Center for Reproductive Medicine. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04445025, a Early Phase 1 study, has completed, sponsored by Colorado Center for Reproductive Medicine.

COMPLETED
Registry status
Early Phase 1
Development phase
30 participants
Enrollment target

Study Summary

Patients who have been previously surgically diagnosed with endometriosis and have embryos predicted to be euploid after in vitro fertilization will be divided into 2 groups via randomization. The test group will receive Elagolix for 60 days prior to starting frozen embryo transfer preparation. The control group will be given leuprolide acetate every 28 days x 2 prior to starting the frozen embryo transfer preparation. Comparative implantation rates between two groups of patients will be evaluated

Primary Outcome

Implantation rates of both groups will be compared (defined as number of intrauterine gestational sacs with visible cardiac activity noted on ultrasound examination performed 2-3 weeks after initial positive pregnancy test)

Interventions

  • DRUG Elagolix 200 MG
  • DRUG Leuprolide Acetate 3.75 MG/ML
  • DIAGNOSTIC_TEST Lab work

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2020-09-01
Est. Completion 2024-12-30
Phase Early Phase 1

What the finished NCT04445025 record still lists

NCT04445025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 3 interventions - of which Elagolix 200 MG is the first listed.

NCT04445025 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04445025 about?

NCT04445025 is a clinical study titled "Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis". Patients who have been previously surgically diagnosed with endometriosis and have embryos predicted to be euploid after in vitro fertilization will be divided into 2 groups via randomization. The test group will receive Elagolix for 60 days prior to starting frozen embryo transfer preparation. The ...

What is the current status of trial NCT04445025?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2020-09-01. Estimated completion is 2024-12-30.

What interventions are being tested in trial NCT04445025?

The interventions under investigation include: Elagolix 200 MG (DRUG), Leuprolide Acetate 3.75 MG/ML (DRUG), Lab work (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04445025?

This trial is sponsored by Colorado Center for Reproductive Medicine, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04445025's enrollment target sits among peer trials

30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 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 NCT04445025, the US trial registry maintained by the National Library of Medicine. NCT04445025 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.