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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00596739

Enrollment

Registered

2008-01-17

Start date

2007-11-30

Completion date

2009-11-30

Last updated

2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Keywords

Bariatric surgery, weight loss surgery, male infertility, Roux-En-Y, gastric banding

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Adult male subjects between the ages of 18-65 undergoing bariatric surgery

Exclusion criteria

* Subjects with abnormal sperm analysis

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	2 years

Countries

United States

Outcome results