Reproductive Hormonal Alterations in Obesity

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-07-31

Brief Summary

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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)

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Detailed Description

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AIM 1: test the hypothesis that reduced pituitary sensitivity to GnRH-induced LH and FSH secretion causes the relative hypogonadotropic hypogonadism of obesity AIM 2: test the hypothesis that the hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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BMI ≥30 kg/m2

Group 2:

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

Gonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2.

Group Type ACTIVE_COMPARATOR

Cetrorelix

Intervention Type DRUG

Abolishes pituitary sensitivity to GnRH.

Gonadorelin-GnRH

Intervention Type DRUG

GnRH is used to stimulate the pituitary gland to produce LH and FSH.

Recombinant LH

Intervention Type DRUG

Used to stimulate ovarian function in women.

Letrozole

Intervention Type DRUG

An aromatase inhibitor.

BMI 18-25 kg/m2

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

Gonadorelin-GnRH (Lutrepulse), GnRH antagonists - Cetrorelix (Cetrotide), Recombinant LH (Luveris) were administered in Aim 1. GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2.

Group Type EXPERIMENTAL

Cetrorelix

Intervention Type DRUG

Abolishes pituitary sensitivity to GnRH.

Gonadorelin-GnRH

Intervention Type DRUG

GnRH is used to stimulate the pituitary gland to produce LH and FSH.

Recombinant LH

Intervention Type DRUG

Used to stimulate ovarian function in women.

Letrozole

Intervention Type DRUG

An aromatase inhibitor.

Interventions

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Cetrorelix

Abolishes pituitary sensitivity to GnRH.

Intervention Type DRUG

Gonadorelin-GnRH

GnRH is used to stimulate the pituitary gland to produce LH and FSH.

Intervention Type DRUG

Recombinant LH

Used to stimulate ovarian function in women.

Intervention Type DRUG

Letrozole

An aromatase inhibitor.

Intervention Type DRUG

Other Intervention Names

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Cetrotide Lutrepulse Luveris Femara

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes