# Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double blind placebo controlled trial (Pregnant)

> **NIH NIH R01** · DUKE UNIVERSITY · 2022 · $173,915

## Abstract

Abstract
Infertility is a common complication of endometriosis; while IVF successfully treats endometriosis-
associated infertility, pregnancy rates are diminished compared to other etiologies of infertility.
Our long- term objectives are to better identify and treat endometriosis related infertility. Our
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 placebo. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF
has been suggested to improve success, however studies have been small and rarely reported
live birth rates. Further, use of this approach is limited by the long treatment time required. Recent
approval of an oral GnRH antagonist for endometriosis provides a novel option for women with
endometriosis who are undergoing IVF. This agent avoids parenteral administration and the
prolonged delay in initiation of action as was seen with GnRH agonists. There have been no
studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility.
We propose a randomized clinical trial of oral GnRH antagonist pre-treatment for women
with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. We
have also recently demonstrated aberrant microRNAs in the circulation of women with
endometriosis, a panel of which we have subsequently validated as a biomarker with high
sensitivity and specificity for the detection of active disease. We secondarily propose that disease
biomarkers will identify women who will benefit from GnRH antagonist pre-treatment, allowing a
precision medicine approach to endometriosis-related infertility. The proposed study is significant
due to the common occurrence of both infertility and endometriosis as well as the lack of precision
in both diagnosis and therapy. We use an innovative approach to identify endometriosis as well
as a novel intervention designed to improve the prognosis of women with endometriosis
undergoing IVF.

## Key facts

- **NIH application ID:** 10834508
- **Project number:** 7R01HD100329-05
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** STEVEN L YOUNG
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $173,915
- **Award type:** 7
- **Project period:** 2019-09-26 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10834508

## Citation

> US National Institutes of Health, RePORTER application 10834508, Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double blind placebo controlled trial (Pregnant) (7R01HD100329-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10834508. Licensed CC0.

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