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

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Endometriosis
Infertility

Type

Interventional

Phase

Phase 3

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Half of the subjects (407) will receive elagolix 200mg twice a day (BID) and the other half of subjects (407) will receive placebo BID, both for a minimum of 60 days before IVF cycle start. For convenience of IVF cycle scheduling, participants may receive up to an additional 14 days of intervention (elagolix or placebo) beyond the minimum 60 days of pre-IVF treatment, such that the last dose of study intervention (elagolix or placebo)is received no more than 24 hours before start of IVF treatment protocol.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: A computer-generated randomization list will be created by the PREGnant Data Coordinating Center (DCC) and randomization will be performed prior to the first dose of elagolix. Randomization will have random sizes (2, 4, or 6) of blocks and be stratified by site, i.e. whole blocks are assigned to sites. The randomization list will not be available to any person involved in the conduct and evaluation of the trial until the trial is complete and database is declared clean and is released by the DCC. Likewise, treatment allocation information will not be accessible to investigators (except for serious safety concerns), trial staff at the site or central laboratory personnel during the trial.Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 38 years
Gender: Only males

Description

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. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to placebo. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. 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. This agent avoids parenteral administration and the prolonged delay in initiation of action as was seen with GnRH agonists. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility. The investigators propose a randomized clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators have also recently demonstrated aberrant microRNAs in the circulation of women with endometriosis, a panel of which investigators have subsequently validated as a biomarker with high sensitivity and specificity for the detection of active disease. It is secondarily proposed that disease biomarkers will identify women who will benefit from GnRH antagonist pre-treatment, allowing a precision medicine approach to endometriosis-related infertility. The proposed study is significant due to the common occurrence of both infertility and endometrioses as well as the lack of precision in both diagnosis and therapy. The investigators use an innovative approach to identify endometriosis as well as a novel intervention designed to improve the prognosis of women with endometriosis undergoing IVF.

Tracking Information

NCT #

NCT04173169

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Colorado, Denver
Northwestern University
University of North Carolina

Investigators

Study Director: Esther Eisenberg, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Principal Investigator: Hugh Taylor, MD Yale University Study Director: Heping Zhang, PhD Yale University Study Director: Nanette Santoro, MD University of Colorado, Denver Study Director: Jared Robbins, MD Northwestern University Study Director: Steven Young, MD, PhD University of North Carolina