Pulsed intravenous follicle-stimulating hormone for women with obesity and fertility problems
Tests follicle-stimulating hormone given in pulses in women with obesity and infertility.
Plain-language title generated from the registry record
Registry title: Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Key facts
- Where
- Aurora, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 37 years old?
Source: NCT06414096, who can take part
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Colorado, Denver
- Trial code
- NCT06414096
- Record updated
- 14 October 2026
- Original description
Hypothesis: The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome (RMS) luteal deficiency phenotype.Read full original descriptionShow less
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
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.
Inclusion: • 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.