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Trial record 14 of 32 for:    Recruiting, Not yet recruiting, Available Studies | obesity | stimulation

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
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Obesity Fertility Drug: Degarelix (GnRH antagonist) Drug: recombinant FSH Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Degarelix

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Katherine Kuhn, MS 303-724-5276 katherine.kuhn@ucdenver.edu
Contact: Kelsey Jones 303-724-5276 kelsey.jones@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Clinical and Translational Research Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Katherine Kuhn    303-724-5276    katherine.kuhn@ucdenver.edu   
Principal Investigator: Alex Polotsky, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Alex Polotsky, MD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02478775     History of Changes
Other Study ID Numbers: 15-0474
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Keywords provided by University of Colorado, Denver:
obesity
fertility
infertility
reproductive hormones
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs