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Completed

NCT Number: NCT02478775

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

Excess maternal weight, especially obesity, influences almost every aspect of fertility, from conception to problems during pregnancy. The investigators will use novel statistical methods to clarify the hormonal changes behind reproductive health conditions. A better understanding of reproductive hormonal changes in obese women may offer a way to identify new treatments.

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Key information

Conditions

Obesity Body Weight Fertility Genital Diseases Infertility Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

21 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Clinical and Translational Research Center

Aurora, Colorado, 80045, United States

About this study

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 undergoing frequent blood sampling studies before and after GnRH (Gonadotropin-releasing hormone) antagonist blockade.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Degarelix (GnRH antagonist)

Drug

Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist degarelix will be given subcutaneously.

Other names: Firmagon

recombinant FSH

Drug

Day-2: Blood samples will again be obtained every 10 minutes for 10 hours. Repeated boluses of exogenous recombinant FSH (rFSH) will be given by IV during this 10 hour visit.

Other names: rFHS

Cetrorelix

Drug

Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist Cetrorelix will be given subcutaneously.

Other names: Cetrotide

Primary outcomes

  1. Difference Between Peak Inhibin B

    Time frame: Every 10 minutes over 2 10-hour frequent blood sampling sessions.

    This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.

Secondary outcomes

  1. Peak Inhibin B Per Subject

    Time frame: Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.

    Peak inhibin B will be measured every 10 minutes during day 1 and day 2 of the study. The highest inhibin B value will be defined as the peak.

  2. Peak E2 Per Subject

    Time frame: Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.

    E2 will be measured every 10 minutes on Day 1 and Day 2 of the study. The highest E2 value will be designated as the peak E2 value.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2015
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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