nctId: NCT06375811 id: 2000027121_temp briefTitle: Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp acronym: PREGnant overallStatus: RECRUITING date: 2024-03-16 date: 2026-06-30 date: 2026-06-30 date: 2024-04-19 date: 2024-04-23 name: Yale University class: OTHER name: University of Colorado, Denver name: Northwestern University name: University of North Carolina name: Duke University name: Johns Hopkins University 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. conditions: Infertility conditions: Endometriosis studyType: INTERVENTIONAL phases: PHASE3 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 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 count: 288 type: ESTIMATED name: Elagolix 200 MG name: Placebo or SOC IVF measure: Live birth rate measure: Fertilization rate measure: Number of embryos transferred measure: Implantation rate measure: Biochemical pregnancy rate measure: Clinical pregnancy rate measure: Miscarriage rate measure: Overall pregnancy complication rate measure: Gestation age at delivery measure: Infant birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Colorado Department of Obstetrics & Gynecology status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Katherine Kuhn role: CONTACT phone: 303-724-5276 email: katherine.kuhn@cuanschutz.edu name: Nanette Santoro role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences status: RECRUITING city: New Haven state: Connecticut zip: 06520 country: United States name: Michele Frank role: CONTACT phone: 203-785-6949 email: michele.frank@yale.edu name: Hugn Taylor role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Northwestern University Department of Obstetrics and Gynecology status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Jessica Almgren-Bell role: CONTACT phone: 312-503-4118 email: jessica.almgrenbell@nm.org name: Emily Jungheim role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Johns Hopkins, Division of Reproductive Science and Women's Health Research status: RECRUITING city: Baltimore state: Maryland zip: 21205 country: United States name: Gaelle Massoud, role: CONTACT phone: 410-583-2763 email: gmassou1@jhmi.edu name: James Segars role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Duke Fertility status: RECRUITING city: Morrisville state: North Carolina zip: 27560 country: United States name: Tifani Panek role: CONTACT phone: 773-706-4202 email: tifani.panek@duke.edu name: Steven Young role: PRINCIPAL_INVESTIGATOR lat: 35.82348 lon: -78.82556 hasResults: False