Pulsatile FSH Treatment for Obesity-Related Infertility
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Recruiting
Phase 1
Interventional Study
Infertility
Obesity
Diminished Ovarian Reserve (DOR)
Diminished Ovarian Reserve
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 19 – 37
- Sex
- Female
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 60 (estimated)
- Sponsor
- University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for women with obesity who have difficulty getting pregnant. Participants will receive treatment with a hormone given through an IV and their hormone levels will be compared to those receiving daily injections of the same hormone.
Are You a Good Fit for This Trial?
You may be able to join if
- I have a BMI between 30 and 40.
- I have been unable to conceive for at least 6 months.
- I have regular menstrual cycles lasting 25-40 days.
- I have a male partner or sperm donor with adequate sperm count.
- I have not been diagnosed with polycystic ovarian syndrome (PCOS).
- My thyroid and prolactin levels are normal.
- I am willing to postpone conception for the first study cycle.
- I accept having an indwelling catheter for the study.
You may not be able to join if
- I have a clinical diagnosis of polycystic ovarian syndrome (PCOS).
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 tr…
Trial Locations
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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…
Contacts