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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)
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
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
1,020 Previous Clinical Trials
520,098 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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a brain tumor before.I have been diagnosed with infertility and am a candidate for IVF.My womb's inner lining is normal, confirmed by special scans and an in-office procedure.I have a psychiatric condition that requires lithium or anti-psychotic medications.I haven't used endometriosis treatments for more than 30 days in the last 4 months.I am younger than 21 or older than 42 years old.I agree to use barrier methods of contraception during my treatment.I have been on approved endometriosis treatment for more than 30 days.I have untreated or untreatable issues with my uterus or fallopian tubes.I do not have any embryos considered normal for transfer.I have not had surgery for endometriosis within the last 10 years.I have been diagnosed with polycystic ovary syndrome.I am experiencing vaginal bleeding that has not been diagnosed.I was diagnosed with endometriosis by surgery within the last 10 years.I have no health issues preventing me from using GnRH treatments.I have kidney, lung, liver, or heart disease.I have at least one healthy embryo ready for transfer.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Test group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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