Pulsatile FSH treatment for women with obesity to improve fertility

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• 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: Asma Giornazi, MS
• Email: asma.giornazi@cuanschutz.edu
• Phone: 303-7245276

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.