Dysregulation of FSH in Obesity: Functional and Statistical Analysis
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|ClinicalTrials.gov Identifier: NCT02478775|
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Fertility||Drug: Degarelix (GnRH antagonist) Drug: recombinant FSH||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Frequent Blood Sampling
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.
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.
Other Name: Firmagon
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.
Other Name: rFHS
- Difference between peak inhibin B [ Time Frame: Every 10 minutes over 10 hours. ]This is defined as the maximum hormone value during the Day2 study minutes after the maximum hormone value during the Day1 study before GnRH antagonist is administered. Participants will be followed for the duration of the hospital stay, an expected average of 26 hours.
- Peak inhibin B per subject [ Time Frame: Every 10 minutes over 10 hours. ]Investigators will compute a composite measure of luteinizing hormone (LH) and FSH pulsatility (pulse frequency, and average pulse amplitude) on day 1 and day 2, along with the means of LH and FSH to assess adequacy of GnRH antagonism and FSH stimulation.
- Peak E2 per subject [ Time Frame: Every 10 minutes over 10 hours. ]Investigators will compute a composite measure of luteinizing hormone (LH) and FSH pulsatility (pulse frequency, and average pulse amplitude) on day 1 and day 2, along with the means of LH and FSH to assess adequacy of GnRH antagonism and FSH stimulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478775
|Contact: Katherine Kuhn, MSfirstname.lastname@example.org|
|Contact: Kelsey Jonesemail@example.com|
|United States, Colorado|
|University of Colorado Clinical and Translational Research Center||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Katherine Kuhn 303-724-5276 firstname.lastname@example.org|
|Principal Investigator: Alex Polotsky, MD|
|Principal Investigator:||Alex Polotsky, MD||University of Colorado, Denver|