Home › Infertility › NCT06414096

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Who can join

Ages 19 to 37 · Women · Healthy volunteers welcome

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:

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About the 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. 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.

What is being tested

• Follicle Stimulating Hormone (drug)

Sponsor: University of Colorado, Denver · Participants: 5 · Started: Oct 1, 2024

Contact the study team

• Katherine Kuhn, MS · Phone: 303-7245276
• Asma Giornazi, MS · Phone: 303-724-5276

Official record on ClinicalTrials.gov — NCT06414096

Locations in the U.S.

Conditions

• Infertility
• Obesity

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.