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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Yale University
Study ID
NCT06375811
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix 200 MG — DRUG
    Elagolix tablet
  • Placebo or SOC IVF — OTHER
    Sugar pill manufactured to mimic Elagolix 200mg

Study Details

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.

Key Dates

Start date
Mar 16, 2024
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
97 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pre-IVF Treatment with 60 day course of oral GnRH antagonist
    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.
  • Other: Pre-IVF Treatment with 60 day course of Placebo or SOC IVF
    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 the participants do not want to delay the IVF procedure.

Primary Outcome Measure

Live birth rate [ Time Frame: Up to 15 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado Department of Obstetrics & GynecologyAuroraColorado80045-
Yale School of Medicine Dept.of Ob/Gyn & Reproductive SciencesNew HavenConnecticut06520-
Northwestern University Department of Obstetrics and GynecologyChicagoIllinois60611-
Johns Hopkins, Division of Reproductive Science and Women's Health ResearchBaltimoreMaryland21205-
Duke FertilityMorrisvilleNorth Carolina27560-

Find similar trials in Aurora, CO

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
University of Colorado Department of Obstetrics & Gynecology· Aurora, COYale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences· New Haven, CTNorthwestern University Department of Obstetrics and Gynecology· Chicago, ILJohns Hopkins, Division of Reproductive Science and Women's Health Research· Baltimore, MDDuke Fertility· Morrisville, NC

Related Studies