Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Eligible age
19–37 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: University of Colorado, Denver
You may qualify if…
- ✓ • BMI between 30 kg/m2 and 40 kg/m
- ✓ Weight stability, i.e. no continued weight loss of \>1lb per week for a minimum of 4 weeks prior to enrollment
- ✓ Normal thyroid stimulating hormone (TSH) and prolactin
- ✓ Anti-Mullerian Hormone (AMH) \> 1 ng/ml or \< 8 ng/mL
- ✓ Willingness to postpone conception for the first study cycle
- ✓ Involuntary inability to conceive for at least 6 months
- ✓ No clinical diagnosis of polycystic ovarian syndrome (PCOS)
- ✓ Documentation of ovulation with luteal progesterone \>6 ng/ml or positive ovulation predictor home testing
Where it's recruiting
Aurora
Source: ClinicalTrials.gov · NCT06414096 · last updated 2026-10-14