NCT02478775

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 21 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Fertility

Interventions

Type	Name	Description
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.
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

• Start date: 2015-07-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2015-06-23
• Last updated: 2024-06-05
• Results posted: 2022-04-07

Locations

1 site across 1 country: United States