Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
University of Colorado, Denver
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.
Description
Design: Crossover interventional study. The investigators have selected this design to allow us to compare each woman to herself in consecutive cycles whenever possible. Methods: Patient population and protocol: The investigators plan to recruit women with obesity for a proof-of-concept study to demonstrate the potential of this treatment to improve fertility. Before such a treatment would be brought into clinical practice, a more comprehensive program of pre-conceptional care would be desirable to improve the metabolic health of women with obesity and minimize pregnancy complications such a…
Eligibility
- Age range
- 19–37 years
- Sex
- Female
- Healthy volunteers
- Yes
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 * Regul…
Interventions
- DrugFollicle Stimulating Hormone
Pulsatile FSH administration via a portable pump.
Location
- University of Colorado Anschutz Medical CampusAurora, Colorado