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Search / Trial NCT02478775

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

Launched by UNIVERSITY OF COLORADO, DENVER · Jun 18, 2015

Trial Information

Current as of May 25, 2025

Completed

Keywords

Obesity Fertility Infertility Reproductive Hormones

ClinConnect Summary

Hypothesis. Insufficient FSH (Follicle-stimulating hormone) pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production.

AIM: To test the hypothesis that insufficient FSH pulsatility, as seen in obesity, results in inadequate folliculogenesis and reduced ovarian steroid and protein production. The investigators will determine if exogenous FSH administered in a pulsatile fashion results in a significant increase of ovarian hormones in obese women. Serial inhibin B and E2 levels will be measured in obese and normal weight women u...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Age between 21 to 39 years old with regular menstrual cycles every 25-40 days
  • Body mass of 18.5 kg/m2-24.9kg/m2 (normal weight controls) or greater than 30.0 kg/m2 (obese group)
  • Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
  • Baseline hemoglobin \>11 gm/dl.
  • Exclusion Criteria:
  • Diagnosis of polycystic ovary syndrome (PCOS), defined by the 2003 Rotterdam criteria as suggested by 2012 NIH Workshop
  • History of chronic disease affecting hormone production, metabolism or clearance or use of thiazolidinediones or metformin (known to interact with reproductive hormones)
  • Use of hormones affecting hypothalamic-pituitary-gonadal (HPO) axis (such as hormonal contraceptives) within 3 months of entry
  • Strenuous exercise (\>4 hours of intense physical activity per week)
  • Pregnancy
  • Breast-feeding
  • Current attempts to conceive
  • Significant recent weight loss or gain

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Alex Polotsky, MD

Principal Investigator

University of Colorado, Denver

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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