NOT_YET_RECRUITING
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
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.
Conditions:
🦠 Infertility 🦠 Obesity
🗓️ Study Start (Actual) June 2024
🗓️ Primary Completion (Estimated) November 2025
✅ Study Completion (Estimated) January 2026
👥 Enrollment (Estimated) 5
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

    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:

    • -
Ages Eligible for Study: 19 Years to 37 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 May 2024
  • First Submitted that Met QC Criteria 10 May 2024
  • First Posted 16 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 May 2024
  • Last Update Posted 23 May 2024
  • Last Verified May 2024