protocolSection identificationModule nctId: NCT06375811, orgStudyIdInfo id: 2000027121_temp, briefTitle: Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp, acronym: PREGnant, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Yale University, class: OTHER, collaborators name: University of Colorado, Denver, collaborators name: Northwestern University, collaborators name: University of North Carolina, collaborators name: Duke University, collaborators name: Johns Hopkins University, descriptionModule briefSummary: 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. 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 those not pretreated with GnRH antagonist., conditionsModule conditions: Infertility, conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Half of the subjects (200, randomized or not randomized) will receive elagolix 200mg twice a day (BID) and the other half of subjects will receive placebo BID or SOC IVF (200, placebo or SOC IVF). Elagolix or placebo will be taken 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., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: For participants who agree to be randomized, 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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: Elagolix 200 MG, interventions name: Placebo or SOC IVF, outcomesModule primaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Fertilization rate, secondaryOutcomes measure: Number of embryos transferred, secondaryOutcomes measure: Implantation rate, secondaryOutcomes measure: Biochemical pregnancy rate, secondaryOutcomes measure: Clinical pregnancy rate, secondaryOutcomes measure: Miscarriage rate, secondaryOutcomes measure: Overall pregnancy complication rate, secondaryOutcomes measure: Gestation age at delivery, secondaryOutcomes measure: Infant birth weight, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Colorado Department of Obstetrics & Gynecology, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Katherine Kuhn, role: CONTACT, phone: 303-724-5276, email: katherine.kuhn@cuanschutz.edu, contacts name: Nanette Santoro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06520, country: United States, contacts name: Michele Frank, role: CONTACT, phone: 203-785-6949, email: michele.frank@yale.edu, contacts name: Hugn Taylor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: Northwestern University Department of Obstetrics and Gynecology, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Jessica Almgren-Bell, role: CONTACT, phone: 312-503-4118, email: jessica.almgrenbell@nm.org, contacts name: Emily Jungheim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Johns Hopkins, Division of Reproductive Science and Women's Health Research, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21205, country: United States, contacts name: Gaelle Massoud,, role: CONTACT, phone: 410-583-2763, email: gmassou1@jhmi.edu, contacts name: James Segars, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Duke Fertility, status: RECRUITING, city: Morrisville, state: North Carolina, zip: 27560, country: United States, contacts name: Tifani Panek, role: CONTACT, phone: 773-706-4202, email: tifani.panek@duke.edu, contacts name: Steven Young, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.82348, lon: -78.82556, hasResults: False