NCT06414096 Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
| NCT ID | NCT06414096 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Colorado, Denver |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2031-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-10-01 with a primary completion date of 2031-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria (obseity): * • 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 Inclusion criteria (DOR): * 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
Contact & Investigator
Nanette Santoro, MD
PRINCIPAL INVESTIGATOR
University of Colorado School of Medicine
Frequently Asked Questions
Who can join the NCT06414096 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 37 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06414096 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06414096 currently recruiting?
Yes, NCT06414096 is actively recruiting participants. Contact the research team at asma.giornazi@cuanschutz.edu for enrollment information.
Where is the NCT06414096 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06414096 clinical trial?
NCT06414096 is sponsored by University of Colorado, Denver. The principal investigator is Nanette Santoro, MD at University of Colorado School of Medicine. The trial plans to enroll 60 participants.