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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. 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

5

Start Date

2024-10-01

Completion Date

2026-11

Last Updated

2024-11-27

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