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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00596739
First received: January 8, 2008
Last updated: August 8, 2011
Last verified: August 2011
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Weight Loss Surgery and Male Fertility

Resource links provided by NLM:


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

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

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

No publications provided

Responsible Party: Samantha Butts, MD, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00596739     History of Changes
Other Study ID Numbers: 805770
Study First Received: January 8, 2008
Last Updated: August 8, 2011
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

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

ClinicalTrials.gov processed this record on April 15, 2014