N/A
Completed N=60
Dysregulation of FSH in Obesity: Functional and Statistical Analysis
Obesity · Fertility
Source: ClinicalTrials.gov NCT02478775 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: Difference Between Peak Inhibin B — 100.8; 38.8 picograms/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between Peak Inhibin B |
100.8; 38.8 | — |
| SECONDARY Peak Inhibin B Per Subject |
103.5; 87.5; 226.5; 126.3 | — |
| SECONDARY Peak E2 Per Subject |
65.1; 72.5; 137.7; 99.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02478775). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.