Trials / Completed
CompletedNCT00596739
A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery
Weight Loss Surgery and Male Fertility
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2009-11-01
- Completion
- 2009-11-01
- First posted
- 2008-01-17
- Last updated
- 2016-08-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00596739. Inclusion in this directory is not an endorsement.