RecruitingPhase 1NCT06414096

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Sponsor

University of Colorado, Denver

Enrollment

5 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Infertility

Summary

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.

Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 37 Years

Inclusion Criteria13

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