← Back to Search

Gonadotropin-releasing hormone (GnRH) antagonist

Elagolix vs Leuprolide for Endometriosis and Infertility

Phase < 1

Waitlist Available

Led By Eric Surrey, MD

Research Sponsored by Colorado Center for Reproductive Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a drug called Elagolix can improve implantation rates in patients with endometriosis who are undergoing IVF.

Who is the study for?

This trial is for women aged 21-42 with surgically confirmed endometriosis, regular menstrual cycles, and at least one embryo ready for IVF transfer. Participants must not have used certain endometriosis treatments recently, agree to use barrier contraception, and have a normal uterine cavity. Women with untreated hydrosalpinx or who've had prolonged GnRH treatments are excluded.

What is being tested?

The study compares the effectiveness of Elagolix versus Leuprolide Acetate in preparing patients with endometriosis for frozen embryo transfers. One group will take Elagolix daily for two months; the other receives Leuprolide injections every four weeks twice before starting embryo transfer prep.

What are the potential side effects?

Elagolix may cause hot flashes, headache, fatigue, insomnia, mood changes, bone loss and change in menstrual bleeding patterns. Leuprolide can lead to similar effects like hot flashes and mood swings but also includes potential risks such as decreased bone density and changes in reproductive hormone levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 weeks after initial positive pregnancy test (approx 14-15 weeks post initiation of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of Implantation Rates

Secondary study objectives

Comparison of Biochemical pregnancy rates

Comparison of hormone levels between the two groups

Comparison of live birth rates and pregnancy loss rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test groupExperimental Treatment2 Interventions

Subjects will receive the medication elagolix

Group II: Control groupActive Control2 Interventions

Subjects will receive leuprolide acetate

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Colorado Center for Reproductive MedicineLead Sponsor

6 Previous Clinical Trials

670 Total Patients Enrolled

5 Trials studying Infertility

616 Patients Enrolled for Infertility

AbbVieIndustry Sponsor

1,024 Previous Clinical Trials

520,451 Total Patients Enrolled

Eric Surrey, MD4.331 ReviewsPrincipal Investigator - Colorado Center for Reproductive Medicine

Colorado Center for Reproductive Medicine

5Patient Review

Dr. Surrey is an excellent physician who is both knowledgeable and kind. He is also very thorough in his explanations and I would highly recommend him to anyone.