drugset / Trial / NCT04173169
Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis
Phase 3
Completed
103 enrolled
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNorthwestern University · collabUniversity of Colorado, Denver · collabUniversity of North Carolina · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2022-03-15
- Primary completion
- 2025-05-02
- Completion
- 2025-05-02
Publications
- Taylor H, Li HJ, Carson S, Flores V, Pal L, Robbins J, Santoro NF, Segars JH, Seifer D, Huang H, Young S, Zhang H. Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial. BMJ Open. 2022 Jun 17;12(6):e052043. doi: 10.1136/bmjopen-2021-052043.
- Pretzel S, Kuhn K, Pal L, Polotsky A, Taylor HS, Zhang H, Robins J, Young SL, Santoro N. Willingness of Women with Endometriosis Planning to Undergo IVF to Participate in a Randomized Clinical Trial and the Effects of the COVID-19 Pandemic on Potential Participation. Reprod Sci. 2022 Feb;29(2):620-626. doi: 10.1007/s43032-021-00705-0. Epub 2021 Aug 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Elagolix | Small molecule | 200 mg | Oral |