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3/4: Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double blind placebo controlled trial (PREGNANT)

Award Number: R01HD100318
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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3/4: Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double blind placebo controlled trial (PREGNANT) - Project Summary 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 micoRNAs 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 endometrioses 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$107,865 )
2024	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	000	5	7/11/2024	NON-COMPETING CONTINUATION	-$107,865
2024	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	001	5	7/30/2024	NON-COMPETING CONTINUATION	$0
2024	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	002	5	8/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = -$107,865

Issue Date FY: 2023 ( Subtotal = $246,736 )
2023	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	001	5	8/16/2023	NON-COMPETING CONTINUATION	$246,736
2023	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	000	4	8/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $246,736

Issue Date FY: 2022 ( Subtotal = $251,381 )
2022	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	001	4	8/15/2022	NON-COMPETING CONTINUATION	$251,381
2022	2021	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	000	3	8/15/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $251,381

Issue Date FY: 2021 ( Subtotal = $256,801 )
2021	2021	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	001	3	9/3/2021	NON-COMPETING CONTINUATION	$256,801
2021	2020	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	000	2	8/10/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $256,801

Issue Date FY: 2020 ( Subtotal = $266,783 )
2020	2020	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	002	2	9/9/2020	NON-COMPETING CONTINUATION	$266,783
2020	2019	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	001	1	9/9/2020	NEW	$0
2020	2019	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	000	1	12/18/2019	NEW	$0
														Subtotal = $266,783

Issue Date FY: 2019 ( Subtotal = $261,797 )
2019	2019	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Child Health and Human Development Extramural Research	000	1	9/26/2019	NEW	$261,797
														Subtotal = $261,797

Grand Total All Awards = $1,175,633

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3/4: Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double blind placebo controlled trial (PREGNANT)

Award Number: R01HD100318

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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