RECRUITING Phase 1 ClinicalTrials.gov

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Sponsor: University of Colorado, Denver • ClinicalTrials.gov ID: NCT06414096

Registry updated: 2026-10-14

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Description

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.

Interventions

Follicle Stimulating Hormone (Drug)
Pulsatile FSH administration via a portable pump.

Eligibility criteria

Inclusion Criteria (obseity): * • 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 * Regular menstrual cycles 25-40 days in length * Male partner (or sperm donor) with adequate sperm (\>14 million sperm per ml) * Hysterosalpingogram or saline infusion sonography demonstrating at least one patent Fallopian tube and a normal uterine cavity * Serum total and free testosterone within the 95% CIearance for women with obesity previously studied in our laboratory. * Acceptance of the indwelling catheter and willingness to take part in the study Inclusion criteria (DOR): * BMI less than 30 kg/m2 * Normal TSH and prolactin * Regular menstrual cycles 25-40 days in length * Male partner (or sperm donor) with adequate sperm (\>14M sperm per ml) * Hysterosalpingogram or saline infusion sonography demonstrating at least one patent Fallopian tube and a normal uterine cavity * Anti-Mullerian Hormone (AMH) \< 1.0 ng/ml * Antral follicle count 8 or less * Willingness to postpone conception for the first study cycle * at least 2 prior canceled cycles for lack of response at maximum dose * Involuntary inability to conceive for at least 6 months * Acceptance of the indwelling catheter and willingness to take part in the study

Conditions

Infertility Obesity Diminished Ovarian Reserve (DOR) Diminished Ovarian Reserve

Locations

University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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