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

Completed · Early Phase 1

Conditions studied: Infertility, Endometriosis

In brief

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

Key facts

Study ID: NCT04445025
Run by: Colorado Center for Reproductive Medicine
People needed: 30
Starts: 2020-09-01
Expected to finish: 2024-12-30
Last updated by the study team: 2025-02-20

Who can join

Age: 21 and older, up to 42. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Diagnosis of infertility who are candidate for IVF
Surgical diagnosis of endometriosis within 10 years of study entry
Willing to sign/give informed consent and adhere to parameters of study
Normal endometrial cavity as diagnosed by 3D ultrasound and office hysteroscopy examinations at baseline or after correction of underlying clinically relevant cavity abnormalities
Day 2-4 serum FSH level ≤ 12 mIu/mL and/or random serum AMH level ≥ 0.9 ng/mL and/or antral follicular phase follicle count obtained by trans-vaginal ultrasound examination ≥ 5
No contraindication to GnRH agonist or GnRH antagonist use
No prolonged use of GnRH agonist or antagonist (> 30 consecutive days) or other treatment for endometriosis within 4 months of study entry
Have at least one euploid embryo available for transfer
Agrees to transfer best quality embryo as determined by CCRM physician and embryology team
Regular menses ranging from 22-36 days
Agrees to use barrier contraception throughout GnRH agonist or antagonist administration
No evidence of untreated hydrosalpinx

You may not qualify if…

Age <21 or > 42 years at time of initiation of IVF cycle
Day 2-4 FSH level >12 mIu/mL or random serum AMH level <1.0 ng/mL and antral follicle count obtained by trans-vaginal ultrasound examination < 5
Planned use of donor oocytes or embryos
Planned use of gestational carrier
Use of GnRH agonist, GnRH antagonist or other approved medical therapy for endometriosis (with the exception of combination contraceptives) for > 30 consecutive days prior to study entry
Unwilling to abide by study parameters or sign informed consent
No documentation of surgical diagnosis of endometriosis with study timeline (10 years of study entry)
Absence of embryos predicted to be euploid available for transfer (embryos with no results may not be included in transfer)
Prior adverse reaction to any GnRH agonist or antagonist
Uncorrected or uncorrectable clinically relevant uterine cavity abnormalities or hydrosalpinx
Acute or chronic renal, pulmonary, hepatic, or cardiac disease
Prior diagnosis of pituitary adenoma or any other intracranial lesion
Menstrual cycles outside the range of inclusion criteria
Diagnosis of polycystic ovary syndrome (PCOS)
Pregnancy prior to study initiation or initiation of endometrial preparation for embryo transfer.
Undiagnosed vaginal bleeding
Clinically relevant adenomyosis as diagnosed by baseline 3D ultrasound exam (and/or MRI if felt to be appropriate)
Bipolar disorder, history of suicidal ideation, any other psychiatric disorder requiring lithium or anti-psychotic medications

Where it is running

Colorado Center for Reproductive Medicine — Lone Tree, Colorado, United States

Full record on ClinicalTrials.gov

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