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

NCT04445025 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-20

No results posted yet for this 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

Conditions

Interventions

DRUG

Elagolix 200 MG

Elagolix 200mg twice daily orally for 60 days prior to beginning frozen embryo transfer preparation

DRUG

Leuprolide Acetate 3.75 MG/ML

Leuprolide Acetate intramuscularly every 28 days (twice) prior to beginning frozen embryo transfer preparation

DIAGNOSTIC_TEST

Lab work

Serum follicle stimulating hormone (FSH), estradiol, luteinizing hormone (LH), progesterone, human chorionic gonadotropin (hCG), serum for microarray analysis, complete blood count, and chemistry panel with liver functions levels will be drawn via blood draw

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Colorado Center for Reproductive Medicine

    lead OTHER

Principal Investigators

  • Eric Surrey, MD · Colorado Center for Reproductive Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-09-30
Completion
2024-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04445025 on ClinicalTrials.gov