Reproductive Hormonal Alterations in Obesity

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined.

--Hypotheses:

1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women)

2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Cetrorelix; Letrozole; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• Aged 18-40 at study entry

• BMI either 18-25 kg/m2 or ≥30 kg/m2

• prolactin (PRL) and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening

• Baseline hemoglobin >11 gm/dl

• History of regular menstrual cycles every 25-35 days if BMI 18-25 kg/m2

• History of regular menstrual cycles every 25-40 days if BMI ≥30 kg/m2

Exclusion Criteria:

• History of chronic disease affecting hormone production, metabolism or clearance

• Use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin)

• Use of hormones within three months of enrollment

• Excessive exercise (>4 hours per week)

• Pregnancy, breast-feeding or current active attempts to conceive