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.
Dysregulation of FSH in Obesity: Functional and Statistical Analysis
Status
Completed
Phase
Not applicable
Enrollment
99
Locations
1
Results
Posted
Publications
1
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
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.
DRUG
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.
Timeline
From registration to results.
First posted
Jun 23, 2015
Study start
Jul 2015
Primary completion
Jun 30, 2021
Study completion
Jun 30, 2021
Results posted
Apr 7, 2022
Registry updated
Jun 5, 2024
Outcomes
What the study measures.
Primary outcomes
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
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.
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.
Eligibility
Who can take part.
- Minimum age
- 21 Years
- Maximum age
- 39 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
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
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, United States
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