Obesity and Weight Loss on Reproductive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00143078
Recruitment Status : Terminated (Close-out of the grant - study ceased on 1/1/2010)
First Posted : September 2, 2005
Last Update Posted : November 16, 2015
Tobacco Settlement Grant
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center

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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model
Study Start Date : June 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Integrated levels of urinary progestin (Pregnanediol-3-Glururonide or Pd3G) at 12 months [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
whole blood & urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants eligible for bariatric surgery; BMI >40 or between 35 and 39.9 with a weight related health problem; Failed medical weight loss; Ages 18-40; Not using hormonal contraceptives; Females have not undergone and bilateral oophrectomy or hysterectomy; Males have not had a vasectomy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00143078

United States, Pennsylvania
The Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Tobacco Settlement Grant
Principal Investigator: Richard Legro, M.D. Penn State University/Milton S. Hershey Medical Center

Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center Identifier: NCT00143078     History of Changes
Other Study ID Numbers: 19366
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: November 16, 2015
Last Verified: November 2015

Keywords provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:
Weight Loss
Reproductive System

Additional relevant MeSH terms:
Weight Loss
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes