Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 5 years 11 months later Nov 2025 → Nov 2031
Primary endpoint added 1 → 2 primary endpoints
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Record History

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  1. Primary completion pushed from Nov 2025 to Nov 2031 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 5 → 60 participants
    • Study completion pushed from Nov 2026 to Jan 2032
    • Eligibility criteria expanded, about 126 words
    • Secondary endpoints expanded, about 17 words
    • Site contact updated
    • Study description expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2024 to Oct 1, 2024
    • Study completion date: Jan 2026 to Nov 2026
    • Study site revised
    v3
  4. Eligibility criteria expanded, about 7 words
    • Study description expanded, about 8 words
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06414096
Lead Sponsor University of Colorado, Denver
Conditions
(from sponsor)		 Infertility, Obesity, Diminished Ovarian Reserve (DOR), Diminished Ovarian Reserve
Related terms Infertility, Obesity
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov