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Pulsatile FSH for Infertility and Obesity

This study is looking at a new way to give Follicle Stimulating Hormone (FSH) to women who have both infertility and obesity. FSH is a hormone important for egg development. Researchers believe that giving FSH in small, regular pulses through a portable pump might help correct problems with hormones that affect fertility in women with obesity. The study will compare this pulsatile FSH treatment to the usual daily FSH injections. The main goal is to see if the pulsatile FSH improves a specific hormone called progesterone (Urinary Pdg concentration) after 4 months. You might be able to join if you are a woman between 19 and 37 years old, have a BMI between 30 and 40, and meet certain hormone levels like AMH. The study is currently unclear about its recruitment status.

Study design
This is an interventional study, meaning participants will receive a treatment. It's a crossover design, so each woman will compare her own results from different treatments.
What's involved
You would undergo an intake examination and laboratory tests. You would receive pulsatile FSH administration via a portable pump for one cycle.
Compensation
Not stated in the trial record.
Follow-up
Your urinary Pdg concentration will be measured at 4 months after treatment.

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NCT06414096

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Recruiting
PHASE1Ages 19–37Interventional
University of Colorado, Denver
~5 participants
Updated 2024-11-27 on ClinicalTrials.gov
What's tested:Follicle Stimulating Hormone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Urinary Pdg concentration
Measured over 4 months

Conditions

Infertility
Obesity

Explore related trials

InfertilityObesityMuellerian-Inhibiting FactorProgesteroneProlactinTestosteroneThyroid-Stimulating Hormone

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Nanette Santoro, MD · PRINCIPAL_INVESTIGATOR · University of Colorado School of Medicine

Who to contact

Katherine Kuhn, MS
[email protected]
303-7245276
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• 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

What this trial measures

  • Urinary Pdg concentration4 months

    The primary endpoint of the study is luteal progesterone metabolite (pregnanediol; Pdg) excretion. Luteal Pdg will be compared in the pulsatile FSH cycle to the daily dose subcutaneous (SQ) cycle. Patients who conceive in the cycle of study will not have their conception cycle included in the analysis.