A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery

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: NCT00596739
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : August 17, 2016
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

A correlation between obesity and male fertility has been observed in a few clinical studies. Normal weight men appear to have higher sperm concentrations and sperm motility when compared to obese men, suggesting that weight loss might improve sperm function. However, there also are reported cases of severe male factor infertility following weight loss surgery in previously fertile men. The aim of this study is to determine if there are differences in the semen analyses and hormone levels of men obtained before and after undergoing weight loss (bariatric) surgery.

This will direct future research and treatment.

Condition or disease
Male Infertility

Detailed Description:

We will recruit 60 subjects for this study. Volunteers will provide pre-operative semen and blood samples prior to undergoing weight-reduction surgery.

Those with normal pre-operative sperm samples will be invited to continue participating in the study by providing subsequent post-operative semen samples and hormonal testing over a two year time period.

It is estimated to take approximately one year to enroll the desired 60 subjects. The study will conclude two years from the last enrollment.

The main analysis will be a comparison of sperm concentrations over time.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Weight Loss Surgery and Male Fertility
Study Start Date : November 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Primary Outcome Measures :
  1. Changes in semen analyses and reproductive hormone measurements [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Trends in semen analysis & reproductive hormone parameters over the two-year data collection period, Changes in semen analysis & reproductive hormone parameters as a function of BMI [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood and Sperm

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult male subjects between the ages of 18-65 undergoing bariatric surgery

Inclusion Criteria:

  • Adult male subjects between the ages of 18-65 undergoing bariatric surgery

Exclusion Criteria:

  • Subjects with abnormal sperm analysis

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): NCT00596739

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Samantha F Butts, MD, MSCE University of Pennsylvania

Responsible Party: University of Pennsylvania Identifier: NCT00596739     History of Changes
Other Study ID Numbers: 805770
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by University of Pennsylvania:
Bariatric surgery, weight loss surgery, male infertility, Roux-En-Y, gastric banding

Additional relevant MeSH terms:
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female