Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Launched by UNIVERSITY OF COLORADO, DENVER · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help women with obesity who are struggling with infertility. Researchers believe that giving a hormone called FSH through an intravenous (IV) line in a special pulsing pattern could improve conditions related to infertility known as Reprometabolic Syndrome. The study will compare this new method to the traditional way of giving FSH with daily injections. The main goal is to see if this new approach helps improve hormone levels related to fertility.

To be eligible for the trial, women need to be between 18 and 40 years old, have a body mass index (BMI) between 30 and 40, and must have been unable to conceive for at least six months. They also need to have regular menstrual cycles and meet other specific health criteria. Participants will receive treatment and will be monitored closely to see how their hormone levels change. It’s important for participants to be willing to delay trying to conceive during the first part of the study. If you meet these criteria and are interested in helping advance understanding of infertility treatments, this trial could be a good opportunity.

Gender

FEMALE

Eligibility criteria

• 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
• Exclusion Criteria:
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