Actively Recruiting
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Led by University of Colorado, Denver · Updated on 2024-11-27
5
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI between 30 kg/m2 and 40 kg/m2
- Stable weight with no loss greater than 1 lb per week for at least 4 weeks before enrollment
- Normal thyroid stimulating hormone (TSH) and prolactin levels
- Anti-Mullerian Hormone (AMH) between 1 and 8 ng/ml
- Willingness to delay conception during the first study cycle
- Inability to conceive for at least 6 months
- No clinical diagnosis of polycystic ovarian syndrome (PCOS)
- Evidence of ovulation with luteal progesterone over 6 ng/ml or positive home ovulation test
- Regular menstrual cycles lasting 25 to 40 days
- Male partner or sperm donor with sperm count over 14 million per ml
- At least one open Fallopian tube and a normal uterine cavity confirmed by imaging
- Serum total and free testosterone within normal range for women with obesity
- Acceptance of the indwelling catheter and willingness to participate in the study
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
K
Katherine Kuhn, MS
CONTACT
A
Asma Giornazi, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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