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Clinical Trials/NCT00143078
NCT00143078
Terminated
Not Applicable

The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model

Milton S. Hershey Medical Center1 site in 1 country35 target enrollmentJune 2005
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Milton S. Hershey Medical Center
Enrollment
35
Locations
1
Primary Endpoint
Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months
Status
Terminated
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to examine how obesity and weight loss following bariatric surgery affect reproductive function. The study is particularly interested in how changes in hormones (those produced in the stomach and fat tissue) following weight loss affect reproductive function. Specifically, we, the researchers at Penn State University, propose to characterize reproductive abnormalities in morbidly obese men and women. We hypothesize that morbid obesity leads to reproductive abnormalities in men and women. We plan to examine the short-term effects of alteration in GI hormones after bariatric surgery on reproductive function. We hypothesize that bariatric surgery radically alters GI hormone expression, resulting in immediate changes to the hypothalamic-pituitary-gonadal axis in men and women. Lastly, we, the researchers, plan to examine the long-term effects of weight loss and changes in adipokines on reproductive function. We hypothesize that the changes in adipokine levels resulting from fat mass reduction lead to substantial long-term improvements in reproductive function and fertility. We also hypothesize that there are sexual dimorphisms in adipokine levels following weight loss, with women experiencing larger changes than men.

Detailed Description

Obesity may influence female reproduction through a variety of mechanisms including: suppressing ovulation; inhibiting ovarian follicular development; and altering endometrial development and implantation. In males, obesity may impair reproductive function by several mechanisms including: decreasing libido, causing erectile dysfunction, influencing semen composition, or sperm function. Therefore the long term goal of the current project is to understand the impact of severe obesity on reproductive function and how this is influenced by dramatic weight loss.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
December 2009
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Richard S. Legro, M.D.

Professor, Obstetrics and Gynecology and Public Health Sciences

Milton S. Hershey Medical Center

Eligibility Criteria

Inclusion Criteria

  • Body mass index (BMI) of greater than 40 or a BMI between 35.5-39.9 and has a weight related health problem, such as diabetes or high blood pressure.
  • Failed medical weight loss
  • Ages of 18-40
  • Not using hormonal contraception or sex steroids
  • Subject is premenopausal and has not undergone a bilateral oophorectomy or hysterectomy
  • Subject's obesity has no medical explanation (hypothyroidism, Cushing's Syndrome, genetic)

Exclusion Criteria

  • Not willing to make a lifelong commitment to the diet and exercise guidelines following bariatric surgery
  • Subject is pregnant or lactating
  • Not willing to use barrier contraceptives or intrauterine device (IUD) to prevent pregnancy for one year following bariatric surgery
  • Post-menopausal, either surgical or natural
  • Subject has had a vasectomy
  • Subject is a smoker

Outcomes

Primary Outcomes

Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months

Time Frame: 12 months

Study Sites (1)

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