This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Obesity and Weight Loss on Reproductive Function

This study has been terminated.
(Close-out of the grant - study ceased on 1/1/2010)
Tobacco Settlement Grant
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center Identifier:
First received: September 1, 2005
Last updated: November 13, 2015
Last verified: November 2015
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 Phase
Obesity Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Morbid Obesity and Weight Loss on Reproductive Function: The Bariatric Surgery Model

Resource links provided by NLM:

Further study details as provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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

Enrollment: 35
Study Start Date: June 2005
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: September 1, 2005
Last Updated: November 13, 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 processed this record on September 21, 2017