Clinical trial

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Recruiting now · Phase 1 · 1 countries · Registry ID NCT06414096

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age19 Years to 37 Years

SexFemale

Healthy volunteersAccepted

ConditionInfertility, Obesity

Full registry criteria

Inclusion Criteria: * • 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 Exclusion Criteria: \-

Treatments and study arms

Follicle Stimulating Hormone

Drug

Pulsatile FSH administration via a portable pump.

Primary outcomes

Urinary Pdg concentration4 months

The primary endpoint of the study is luteal progesterone metabolite (pregnanediol; Pdg) excretion. Luteal Pdg will be compared in the pulsatile FSH cycle to the daily dose subcutaneous (SQ) cycle. Patients who conceive in the cycle of study will not have their conception cycle included in the analysis.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States

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Katherine Kuhn, MSContact

Email · Call 303-724-5276

Nanette Santoro, MDPrincipal Investigator