Status:
TERMINATED
Obesity and Weight Loss on Reproductive Function
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Tobacco Settlement Grant
Conditions:
Obesity
Eligibility:
All Genders
18-40 years
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 pro...
Detailed Description
Obesity may influence female reproduction through a variety of mechanisms including: suppressing ovulation; inhibiting ovarian follicular development; and altering endometrial development and implanta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00143078
Start Date
June 1 2005
End Date
December 1 2009
Last Update
November 16 2015
Active Locations (1)
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1
The Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033