N/A N=60 Diagnostic

Dysregulation of FSH in Obesity: Functional and Statistical Analysis

Obesity · Fertility

Bottom Line

View on ClinicalTrials.gov: NCT02478775 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2022

Primary outcome: Primary: Difference Between Peak Inhibin B — 100.8; 38.8 picograms/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Degarelix (GnRH antagonist) (Drug); recombinant FSH (Drug); Cetrorelix (Drug)
Age: Adult · 21+ yrs
Sex: Female
Sponsor: University of Colorado, Denver
Primary completion: Jun 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

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.