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Dysregulation of FSH in Obesity: Functional and Statistical Analysis

Primary Purpose

Obesity, Fertility

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Degarelix (GnRH antagonist)
recombinant FSH
Cetrorelix
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring obesity, fertility, infertility, reproductive hormones

Eligibility Criteria

21 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Clinical and Translational Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Frequent Blood Sampling, Degarelix

Frequent Blood Sampling, Cetrorelix

Arm Description

Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.

Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 7, 2015
Last Updated
March 15, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02478775
Brief Title
Dysregulation of FSH in Obesity: Functional and Statistical Analysis
Official Title
Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Fertility
Keywords
obesity, fertility, infertility, reproductive hormones

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Frequent Blood Sampling, Degarelix
Arm Type
Experimental
Arm Description
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Degarelix (GnRH antagonist) blockade over a 2-day period. This arm was terminated due to Adverse Events and the study was continued with the Cetrorelix product.
Arm Title
Frequent Blood Sampling, Cetrorelix
Arm Type
Experimental
Arm Description
Investigators will assess the change in inhibin B levels following repeated bolus dosing of recombinant FSH (rFHS) following Cetrorelix blockade over a 2-day period.
Intervention Type
Drug
Intervention Name(s)
Degarelix (GnRH antagonist)
Other Intervention Name(s)
Firmagon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
recombinant FSH
Other Intervention Name(s)
rFHS
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetrorelix
Other Intervention Name(s)
Cetrotide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference Between Peak Inhibin B
Description
This is defined as the maximum hormone value during Day 1 of the study subtracted from the maximum hormone value during Day 2.
Time Frame
Every 10 minutes over 2 10-hour frequent blood sampling sessions.
Secondary Outcome Measure Information:
Title
Peak Inhibin B Per Subject
Description
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.
Time Frame
Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.
Title
Peak E2 Per Subject
Description
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.
Time Frame
Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Polotsky, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Clinical and Translational Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dysregulation of FSH in Obesity: Functional and Statistical Analysis

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