Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Recruiting · NCT06414096 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States