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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00596739
First received: January 8, 2008
Last updated: August 15, 2016
Last verified: August 2016
  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
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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   (Adult)
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
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 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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00596739     History of Changes
Other Study ID Numbers: 805770 
Study First Received: January 8, 2008
Last Updated: August 15, 2016
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 December 02, 2016