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

Part of paid clinical trials in Lone Tree, Colorado.

Sponsor: Colorado Center for Reproductive Medicine
Study ID: NCT04445025
Phase: EARLY_PHASE1
Status: Completed

Conditions

Endometriosis
Infertility

Eligibility Criteria

Sex: FEMALE
Age: 21 Years - 42 Years
Healthy Volunteers: Accepted

Interventions

Elagolix 200 MG — DRUG
Elagolix 200mg twice daily orally for 60 days prior to beginning frozen embryo transfer preparation
Leuprolide Acetate 3.75 MG/ML — DRUG
Leuprolide Acetate intramuscularly every 28 days (twice) prior to beginning frozen embryo transfer preparation
Lab work — DIAGNOSTIC_TEST
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

Study Details

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