Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Description

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 Overview

Study Details

Study overview

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.

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Condition
Infertility
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

19 Years to 37 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Colorado, Denver,

Nanette Santoro, MD, PRINCIPAL_INVESTIGATOR, University of Colorado School of Medicine

Study Record Dates

2026-11