Clinical trial NCT02478775: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Fertility
Keywords: obesity
fertility
infertility
reproductive hormones
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2015-06-23
Enrollment: 99
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Difference Between Peak Inhibin B
timeFrame: Every 10 minutes over 2 10-hour frequent blood sampling sessions.
Secondary outcomes:
measure: Peak Inhibin B Per Subject
timeFrame: Every 10 minutes over 10 hours on Day 1 and Day 2 of the study.
measure: Peak E2 Per Subject
timeFrame: Every 10 minutes over 10 hours of Day 1 and Day 2 of the study.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Clinical and Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Alex Polotsky, MD
role: PRINCIPAL_INVESTIGATOR
References: