Dysregulation of FSH in Obesity: Functional and Statistical Analysis

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02478775
• Other study ID #: 15-0474
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility
• Obesity

Intervention

Drug:
• Degarelix (GnRH antagonist)
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.
• recombinant FSH
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.
• Cetrorelix
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.

Locations

Country	Name	City	State
United States	University of Colorado Clinical and Translational Research Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference Between Peak Inhibin B	This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.	Every 10 minutes over 2 10-hour frequent blood sampling sessions.
Secondary	Peak Inhibin B Per Subject	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.	Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.
Secondary	Peak E2 Per Subject	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.	Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.