NCT06414096RecruitingPhase 1
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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. This study will also try to rescue the diminished ovarian reserve phenotype in the same fashion. 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 May 2024
- Start date
- 1 Oct 2024
- Primary completion date
- Nov 2031
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Obesity
- NCT number
- NCT06414096
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 1 Oct 2024 to the primary completion date, Nov 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- • 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
- BMI less than 30 kg/m2
- Normal TSH and prolactin
- Regular menstrual cycles 25-40 days in length
- Male partner (or sperm donor) with adequate sperm (\>14M sperm per ml)
- Hysterosalpingogram or saline infusion sonography demonstrating at least one patent Fallopian tube and a normal uterine cavity
- Anti-Mullerian Hormone (AMH) \< 1.0 ng/ml
- Antral follicle count 8 or less
- Willingness to postpone conception for the first study cycle
- at least 2 prior canceled cycles for lack of response at maximum dose
- Involuntary inability to conceive for at least 6 months
- Acceptance of the indwelling catheter and willingness to take part in the study
Age in the registry: 19 years to 37 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.