Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis

What Was Tested

In this phase 3 trial, researchers set out to test Elagolix (non-peptide) for endometriosis.

A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate.

It had two arms (groups): Pre-IVF Treatment with 60 day course of oral GnRH antagonist (active comparator) and Pre-IVF Treatment with 60 day course of Placebo or SOC IVF (other).

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.

The registry classes the interventions as drug and other.

More on the Plan

Infertility is a common complication of endometriosis; while IVF successfully treats endometriosis-associated infertility, pregnancy rates are diminished compared to other etiologies of infertility.

The study's long- term objectives are to better identify and treat endometriosis related infertility.

Further, use of this approach is limited by the long treatment time required.

Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF.

Who Took Part

103 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women who plan to undergo IVF for treatment of infertility. Age ≥18 and \<40 years at time of egg retrieval or signing informed consent. Body mass index (BMI) of 18-40 kg/m2 (both inclusive) at screening. Negative urine or cervical swab for gonorrhea and chlamydia within 12 months of screening. Willing and able to comply with trial procedures, including reporting of obstetrical outcomes after delivery.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: use of depot medroxyprogesterone acetate (mpa) (injectable) or birth control implants (e.g., implanon® or nexplanon®) within 6 months of study start°; continuous use of oral progestins (mpa, neta) within 1 month of study start°; pregnancy greater than 8 weeks in length within the last 6 months.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Elagolix (non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Elagolix (non-peptide) group and the comparison group ran side by side rather than switching.

As a double-blind Elagolix (non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2022-03-15 with completion listed for 2025-05-02.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Live Birth Rate (time frame: Up to 15 months).

It also tracked 9 secondary outcomes, for example Fertilization Rate, Number of Embryos Transferred, Implantation Rate, Biochemical Pregnancy Rate, Clinical Pregnancy Rate and Miscarriage Rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Elagolix (non-peptide) in 103 people with endometriosis.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Elagolix (non-peptide) compound page, Endometriosis research.