Infertility study: Follicle Stimulating Hormone
Official title Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
ClinicalTrials.gov ID: NCT06414096
What this study is testing
What is Follicle Stimulating Hormone (FSH)?
An investigational pulsatile IV administration via a portable pump being studied as a potential treatment for infertility in women with obesity. FSH is designed to stimulate ovarian follicle development.
Also referred to as FSH.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether giving FSH in short IV pulses can fix hormone problems and improve ovarian function in obese women compared with the usual daily FSH shots.
- Who it's for
- Obese women who have trouble getting pregnant and have a diminished ovarian reserve.
- What's involved
- Participants will receive one cycle of IV pulsatile FSH and another cycle of daily FSH injections at the same total dose, with blood tests to measure hormone output.
- Time commitment
- The trial covers about two menstrual cycles, requiring clinic visits for IV infusions, daily injections, and blood draws during each cycle.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 37, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 37 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.