A Study of the Pre- and Post-Operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-Reduction Surgery - Full Text View

Sponsored by:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00596739

Purpose

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
Male Infertility

MedlinePlus related topics: Infertility Weight Control Weight Loss Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Weight Loss Surgery and Male Fertility

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Changes in semen analyses and reproductive hormone measurements [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood and Sperm

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2011

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subjects with abnormal sperm analysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596739

Contacts

Contact: Samantha F Butts, MD, MSCE

215-662-2975

sbutts@obgyn.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sub-Investigator: Kathryn Calhoun, MD

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator:

Samantha F Butts, MD, MSCE

University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania ( Samantha Butts, MD, MSCE )
Study ID Numbers:	805770
Study First Received:	January 8, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00596739
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Bariatric surgery, weight loss surgery, male infertility, Roux-En-Y, gastric banding

Study placed in the following topic categories:

Genital Diseases, Female
Body Weight
Infertility

Infertility, Male
Weight Loss
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 16, 2009