A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Weight Loss Surgery and Male Fertility|
- Changes in semen analyses and reproductive hormone measurements [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||November 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596739
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Samantha F Butts, MD, MSCE||University of Pennsylvania|