Dysregulation of FSH in Obesity: Functional and Statistical Analysis
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 21 - 39 |
| Updated: | 5/9/2018 |
| Start Date: | July 2015 |
| End Date: | June 2019 |
| Contact: | Anahit Malkhasyan |
| Email: | anahit.malkhasyan@ucdenver.edu |
| Phone: | 303-724-5276 |
Dysregulation of Follicle Stimulating Hormone (FSH) in Obesity: Functional and Statistical Analysis
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.
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.
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.
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.
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
We found this trial at
1
site
Aurora, Colorado 80045
Principal Investigator: Alex Polotsky, MD
Phone: 303-724-6501
Click here to add this to my saved trials
