Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06414096
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diminished Ovarian Reserve
  • Diminished Ovarian Reserve (DOR)
  • Infertility
  • Obesity

Eligibility Criteria

Sex
FEMALE
Age
19 Years - 37 Years
Healthy Volunteers
Accepted

Interventions

  • Follicle Stimulating Hormone — DRUG
    Pulsatile FSH administration via a portable pump.

Study Details

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 Dates

First listed
May 16, 2024
Start date
Oct 1, 2024
Status verified
Oct 2026
Primary completion
Nov 30, 2031
Completion
Jan 31, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Conventional Subcutaneous FSH Dosing
    A daily gonadotropin dose (typically 75-450 IU) will be assigned and adjusted, based on clinical criteria and, if known, past response to hormones. Recombinant human FSH (rhFSH) will be given as a daily subcutaneous injection, as is performed, by patients at home, in routine clinical practice.
  • Experimental: Pulsatile IV FSH Dosing
    participants will receive the same daily rhFSH dose (based on clinical practice criteria); however, it will be delivered via a portable infusion pump with reservoir (Avocet Infusion Pump, Eitan Medical LTD) that will provide an IV bolus (100-500 µl) every 90 minutes, a frequency that has previously been shown to result in physiologic ovulatory cycles in GnRH deficient women (Martin). The total gonadotropin dose delivered over a 24 hour period will be typically 75-450 IU, assigned based on standard of care clinical criteria (max dose is 900IU per clinical care guidelines). Participants will be provided with a 100mL preloaded reservoir, calibrated to deliver the approved standard of care dosing, in 16 boluses (100-500µl) over 24 hours (q 90min), for 7-12 days. Each 100 ml reservoir has capacity for 200 doses if the volume is 500 µl, which is sufficient for the typical 7- 12-day protocol.

Primary Outcome Measure

Urinary Pdg concentration [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045
Asma Giornazi, MS
[email protected]
303-724-5276
Nanette Santoro, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

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By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Colorado Anschutz Medical Campus· Aurora, CO

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