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GnRH Antagonist

Pre-IVF GnRH Antagonist for Endometriosis-related Infertility (PREGnant Trial)

Phase 3
Waitlist Available
Led By Hugh Taylor, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women who plan to undergo IVF for treatment of infertility.
Age ≥18 and <40 years at time of egg retrieval or signing informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months
Awards & highlights
Pivotal Trial

Summary

This trial tests a pill that helps women with endometriosis who are undergoing IVF. These women often have lower success rates with IVF, and the pill helps manage hormone levels to improve their chances of having a baby.

Who is the study for?
Women aged 18-40 with diagnosed endometriosis planning IVF can join. They must have a BMI of 18-40, no severe uterine issues, at least one healthy ovary, and an AMH level over 0.5ng/ml within the last year. Exclusions include recent use of certain contraceptives or hormone treatments, more than two failed IVF attempts, untreated reproductive tract conditions, certain cancers in the past five years, planned pelvic surgeries during the trial period.
What is being tested?
The study is testing if taking Elagolix (a GnRH antagonist) before starting IVF improves live birth rates for women with endometriosis compared to those who don't take it but undergo standard IVF treatment.
What are the potential side effects?
Elagolix may cause side effects like hot flashes, headache, fatigue, insomnia and mood changes. It might also affect bone density leading to osteoporosis risk over long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women who are planning to have In Vitro Fertilization (IVF) treatment for infertility will not be able to participate.
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I am between 18 and 40 years old.
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My endometriosis was confirmed by surgery or pathology within the last 10 years, or I have an ovarian cyst linked to endometriosis.
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You have a body mass index (BMI) between 18 and 40 kilograms per square meter.
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My uterus is healthy and has no major issues for embryo transfer.
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I have at least one healthy ovary, possibly with an endometrioma.
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You are willing and able to comply with trial procedures, including reporting of obstetrical outcomes after delivery.
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You are a woman who is planning to have in vitro fertilization (IVF) to help with infertility.
Select...
My endometriosis was confirmed by surgery or pathology within the last 10 years, or I have an ovarian cyst linked to endometriosis.
Select...
My AMH level is above 0.5ng/ml, or I have a high-quality blastocyst for FET.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Live birth rate
Secondary study objectives
Biochemical pregnancy rate
Clinical pregnancy rate
Fertilization rate
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pre-IVF Treatment with 60 day course of Placebo or SOC IVFExperimental Treatment1 Intervention
For those who agree to be randomized, subjects will be randomized to placebo, BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day. This arm will also include participants who want to continue their ongoing or planned IVF and follow standard of care (SOC) (SOC IVF) if they do not want to delay the IVF procedure.
Group II: Pre-IVF Treatment with 60 day course of oral GnRH antagonistActive Control1 Intervention
For those who agree to be randomized, subjects will be randomized to elagolix 200mg BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day. This arm will also include participants who do not want to be randomized while choose elagolix.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
GnRH antagonists inhibit GnRH receptors in the pituitary gland, preventing the release of gonadotropins (LH and FSH) and subsequently reducing estrogen production. This mechanism is particularly beneficial for managing endometriosis, a condition that can impair fertility. By understanding how these treatments regulate hormonal imbalances and improve ovarian function, infertility patients can make informed decisions about their treatment options to enhance their chances of successful conception.
Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome.GnRH-antagonists in reproductive medicine.Treatment of uterine fibroids with a slow-release formulation of the gonadotrophin releasing hormone antagonist Cetrorelix.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,927 Previous Clinical Trials
3,031,620 Total Patients Enrolled
15 Trials studying Infertility
96,101 Patients Enrolled for Infertility
Northwestern UniversityOTHER
1,649 Previous Clinical Trials
958,659 Total Patients Enrolled
7 Trials studying Infertility
2,348 Patients Enrolled for Infertility
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,061 Previous Clinical Trials
2,745,036 Total Patients Enrolled
34 Trials studying Infertility
20,391 Patients Enrolled for Infertility
University of Colorado, DenverOTHER
1,809 Previous Clinical Trials
2,822,187 Total Patients Enrolled
13 Trials studying Infertility
30,008 Patients Enrolled for Infertility
University of North CarolinaOTHER
170 Previous Clinical Trials
1,455,352 Total Patients Enrolled
4 Trials studying Infertility
870 Patients Enrolled for Infertility
Emily Jungheim, MDStudy DirectorNorthwestern University
1 Previous Clinical Trials
288 Total Patients Enrolled
1 Trials studying Infertility
288 Patients Enrolled for Infertility
Jared Robbins, MDStudy DirectorNorthwestern University
Esther Eisenberg, MDStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
3 Previous Clinical Trials
242 Total Patients Enrolled
2 Trials studying Infertility
203 Patients Enrolled for Infertility
Heping Zhang, PhDStudy DirectorYale University
12 Previous Clinical Trials
4,835 Total Patients Enrolled
8 Trials studying Infertility
3,677 Patients Enrolled for Infertility
Abisola Tepede, PharmDStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Media Library

Elagolix (GnRH Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04173169 — Phase 3
Infertility Research Study Groups: Pre-IVF Treatment with 60 day course of oral GnRH antagonist, Pre-IVF Treatment with 60 day course of Placebo or SOC IVF
Infertility Clinical Trial 2023: Elagolix Highlights & Side Effects. Trial Name: NCT04173169 — Phase 3
Elagolix (GnRH Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04173169 — Phase 3
Infertility Patient Testimony for trial: Trial Name: NCT04173169 — Phase 3
~15 spots leftby May 2025
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