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RECRUITING
NCT06414096
PHASE1

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

Hypothesis: The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome (RMS) luteal deficiency phenotype. Specific Aim: To test the hypothesis that pulsatile IV administration of FSH will rescue the impaired folliculogenesis and relative hypogonadotropic hypogonadism, characteristic of obesity. This study will also try to rescue the diminished ovarian reserve phenotype in the same fashion. The investigators will accomplish this by administering a cycle of pulsatile FSH to women with obesity and comparing their hormone output to a cycle using conventional, daily FSH injection at the identical daily dose. The primary outcome will be luteal phase progesterone excretion.

Key Details

Gender

FEMALE

Age Range

19 Years - 37 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-01

Completion Date

2032-01

Last Updated

2026-10-14

Healthy Volunteers

Yes

Interventions

DRUG

Follicle Stimulating Hormone

Pulsatile FSH administration via a portable pump.

Locations (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States