Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis - A Prospective Clinical Trial
Yale University
Summary
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.
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 those not pretreated with GnRH antagonist. The use of gonadotropin relea…
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Women who plan to undergo IVF for treatment of infertility. 2. Age ≥18 and \<40 years at time of egg retrieval or signing informed consent. 3. Documentation of diagnosis of endometriosis by surgical visualization of endometriosis (laparoscopy or laparotomy) or diagnosis by pathology within the last 10 years before the initial trial entry visit or documentation of ovarian endometrioma \>2 cm or two or more smaller endometriomas that total \>2 cm in diameter. If entry is based on the presence of an endometrioma, transvaginal ultrasound evaluation must document the same un…
Interventions
- DrugElagolix 200 MG
Elagolix tablet
- OtherPlacebo or SOC IVF
Sugar pill manufactured to mimic Elagolix 200mg
Locations (5)
- University of Colorado Department of Obstetrics & GynecologyAurora, Colorado
- Yale School of Medicine Dept.of Ob/Gyn & Reproductive SciencesNew Haven, Connecticut
- Northwestern University Department of Obstetrics and GynecologyChicago, Illinois
- Johns Hopkins, Division of Reproductive Science and Women's Health ResearchBaltimore, Maryland
- Duke FertilityMorrisville, North Carolina