A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery
|First Received Date ICMJE||January 8, 2008|
|Last Updated Date||August 8, 2011|
|Start Date ICMJE||November 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Changes in semen analyses and reproductive hormone measurements [ Time Frame: 2 years ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00596739 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery|
|Official Title ICMJE||Weight Loss Surgery and Male Fertility|
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.
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
Blood and Sperm
|Sampling Method||Non-Probability Sample|
Adult male subjects between the ages of 18-65 undergoing bariatric surgery
|Condition ICMJE||Male Infertility|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||60|
|Estimated Completion Date||November 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00596739|
|Other Study ID Numbers ICMJE||805770|
|Has Data Monitoring Committee||No|
|Responsible Party||Samantha Butts, MD, MSCE, University of Pennsylvania|
|Study Sponsor ICMJE||University of Pennsylvania|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Pennsylvania|
|Verification Date||August 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP