NCT06414096 · University of Colorado, Denver
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
What this study is about
Hypothesis: The investigators hypothesize that pulsatile FSH given through a vein (IV) 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 27, 2024 · Source of record for eligibility and locations