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

Recruiting in Palo Alto (17 mi)

+6 other locations

Hugh Taylor, MD < Yale School of Medicine

Overseen ByHugh Taylor, MD

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Yale University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Women who are planning to have In Vitro Fertilization (IVF) treatment for infertility will not be able to participate.

I am between 18 and 40 years old.

My endometriosis was confirmed by surgery or pathology within the last 10 years, or I have an ovarian cyst linked to endometriosis.

You have a body mass index (BMI) between 18 and 40 kilograms per square meter.

AMH >= 0.5ng/ml, within 12 months of egg collection for a FET or within 12 months of a fresh IVF cycle start.

My uterus is healthy and has no major issues for embryo transfer.

I have at least one healthy ovary, possibly with an endometrioma.

Negative urine or cervical swab for gonorrhea and chlamydia within 12 months of screening.

You are willing and able to comply with trial procedures, including reporting of obstetrical outcomes after delivery.

You are a woman who is planning to have in vitro fertilization (IVF) to help with infertility.

My endometriosis was confirmed by surgery or pathology within the last 10 years, or I have an ovarian cyst linked to endometriosis.

My AMH level is above 0.5ng/ml, or I have a high-quality blastocyst for FET.

Negative urine or cervical swab for gonorrhea and chlamydia within 12 months of screening

Participant Groups

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.

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.

Elagolix is already approved in United States for the following indications:

🇺🇸 Approved in United States as Orilissa for: