Pulsatile FSH treatment for women with obesity to improve fertility
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
This study is testing if a new way of giving hormone treatment can help women with obesity who are having trouble getting pregnant.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 19 Years to 37 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06414096 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effects of pulsatile intravenous administration of Follicle Stimulating Hormone (FSH) on women with obesity who are experiencing infertility. The study will compare the hormonal outcomes of pulsatile FSH treatment to conventional daily FSH injections, focusing on luteal phase progesterone excretion as the primary outcome. By using a crossover design, each participant will serve as their own control, allowing for a direct comparison of treatment effects across different cycles. The goal is to assess the potential of this innovative approach to enhance folliculogenesis and address reproductive hormone deficiencies associated with obesity.
Who should consider this trial
Good fit: Ideal candidates for this study are women with obesity (BMI between 30 and 40) who have been unable to conceive for at least six months and meet specific hormonal and reproductive criteria.
Not a fit: Patients with a clinical diagnosis of polycystic ovarian syndrome (PCOS) or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve fertility outcomes for women with obesity by correcting hormonal imbalances.
How similar studies have performed: While the approach of pulsatile FSH administration is innovative, similar studies have shown promise in addressing reproductive hormone deficiencies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Nanette Santoro, MD — University of Colorado School of Medicine
- Study coordinator: Katherine Kuhn, MS
- Email: Katherine.Kuhn@cuanschutz.edu
- Phone: 303-7245276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.