Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 37
Healthy Volunteers: t
View:

• • 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

Locations
United States
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Katherine Kuhn, MS
Katherine.Kuhn@cuanschutz.edu
303-7245276
Backup
Asma Giornazi, MS
Asma.Gioranzi@ucdenver.edu
303-724-5276
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-11
Participants
Target number of participants: 5
Treatments
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.
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov