A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00596739|
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : August 17, 2016
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 or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Weight Loss Surgery and Male Fertility|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
- Changes in semen analyses and reproductive hormone measurements [ Time Frame: 2 years ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596739
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Samantha F Butts, MD, MSCE||University of Pennsylvania|