Overview

This trial is active, not recruiting.

Condition male infertility
Sponsor University of Pennsylvania
Start date November 2007
End date November 2011
Trial size 60 participants
Trial identifier NCT00596739, 805770

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Changes in semen analyses and reproductive hormone measurements
time frame: 2 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male participants from 18 years up to 65 years old.

Inclusion Criteria: - Adult male subjects between the ages of 18-65 undergoing bariatric surgery Exclusion Criteria: - Subjects with abnormal sperm analysis

Additional Information

Official title Weight Loss Surgery and Male Fertility
Principal investigator Samantha F Butts, MD, MSCE
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Pennsylvania.