Recruiting
Phase 1

Pulsatile FSH

Sponsor:

University of Colorado, Denver

Code:

NCT06414096

Conditions

Infertility

Obesity

Eligibility Criteria

Sex: Female

Age: 19 - 37

Healthy Volunteers: Accepted

Interventions

Follicle Stimulating Hormone

Study Details

Brief 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.

Conditions

Infertility

Obesity

Study ID

NCT06414096

Start date

Oct 1, 2024

Status verified date

Nov, 2024

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 37

Healthy Volunteers: Accepted

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:

-

Study Design

Enrollment

5 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Conventional Subcutaneous FSH Dosing

A daily gonadotropin dose (typically 75-450 IU) will be assigned and adjusted, based on clinical criteria and, if known, past response to hormones. Recombinant human FSH (rhFSH) will be given as a daily subcutaneous injection, as is performed, by patients at home, in routine clinical practice.

experimental: Pulsatile IV FSH Dosing

participants will receive the same daily rhFSH dose (based on clinical practice criteria); however, it will be delivered via a portable infusion pump with reservoir (Avocet Infusion Pump, Eitan Medical LTD) that will provide an IV bolus (100-500 µl) every 90 minutes, a frequency that has previously been shown to result in physiologic ovulatory cycles in GnRH deficient women (Martin). The total gonadotropin dose delivered over a 24 hour period will be typically 75-450 IU, assigned based on standard of care clinical criteria (max dose is 900IU per clinical care guidelines). Participants will be provided with a 100mL preloaded reservoir, calibrated to deliver the approved standard of care dosing, in 16 boluses (100-500µl) over 24 hours (q 90min), for 7-12 days. Each 100 ml reservoir has capacity for 200 doses if the volume is 500 µl, which is sufficient for the typical 7- 12-day protocol.

Interventions

Follicle Stimulating Hormone

Pulsatile FSH administration via a portable pump.

Primary outcome measure

  • Urinary Pdg concentration [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Katherine Kuhn, MS

303-7245276Katherine.Kuhn@cuanschutz.edu

Asma Giornazi, MS

303-724-5276Asma.Gioranzi@ucdenver.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Katherine Kuhn, MS

303-724-5276Katherine.Kuhn@cuanschutz.edu

Principal Investigator:

Nanette Santoro, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 27, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-11-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.