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Improving Ovarian Response in Refractory Infertility with Pulsatile Follicle Stimulating Hormone (FSH)

Award Number: R01HD121539
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/05/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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Improving Ovarian Response in Refractory Infertility with Pulsatile Follicle Stimulating Hormone (FSH) - PROJECT SUMMARY Overweight and reproductive aging are two prevalent factors in female fertility that currently have no satisfactory treatment. Over 40% of adult women are obese and thus potentially affected by weight-related subfertility. Additionally, women with diminished ovarian reserve related to reproductive aging represent 26% of the US IVF population. Not only are both fertility factors prevalent, both are increasing: neither the obesity epidemic nor the postponement of childbirth to historically late ages show any signs of reversal, making these important public health issues. Therefore, this proposal represents a timely approach to improving these urgent and persistent fertility issues. The central concept of this translational proposal is that the fundamental pattern of FSH stimulation of ovarian follicles is critical to their optimal function and therefore to fertility potential. We propose to translate the paradigm-shifting observation that a pulsatile pattern of FSH release results in enhanced follicle growth from a genetically engineered mouse model to the human. Our preliminary data support that improved follicle growth is observed in women with obesity exposed to pulsatile FSH delivery. In Aim 1, we shall test the hypothesis that pulsatile FSH administration to women with obesity corrects their corpus luteum insufficiency phenotype by administering a cycle of pulsatile FSH and comparing hormone output to a cycle of conventional, daily FSH injection at the identical daily dose, in a crossover design with luteal progesterone excretion as a primary end point. In Aim 2, we shall test the hypothesis that age-related infertility in women can be corrected by pulsatile FSH delivery by administering pulsatile FSH to women with a diagnosis of diminished ovarian reserve who are undergoing a planned IVF cycle and measuring the number of oocytes recovered compared to a conventional daily dose FSH cycle in a two-group comparison design. In Aim 3, we will assess granulosa cell gene expression and transcriptional regulation in participants from Aim 2 in an exploratory fashion to identify gene expression and transcription similarities and differences to what has been observed in mice. Our hypothesis is that pulsatile FSH stimulation enhances follicle survival factors and pathways. The proposed studies have the potential to shed new light on the relationship between gonadotropin delivery and follicle function to be applied to two common and difficult-to-treat conditions in female infertility, and if successful, the methodology will be readily scalable into randomized, clinical trials that may be able to provide new and effective therapies for female infertility.


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: 2026 ( Subtotal = $343,217 )
2026	2026	THE REGENTS OF THE UNIVERSITY OF COLORADO	13001 E 17TH PL STE F428	AURORA	CO	80045	ADAMS	USA	Child Health and Human Development Extramural Research	000	1	9/4/2026	NEW	$343,217
														Subtotal = $343,217

Grand Total All Awards = $343,217

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Improving Ovarian Response in Refractory Infertility with Pulsatile Follicle Stimulating Hormone (FSH)

Award Number: R01HD121539

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/05/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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