Bariatric Surgery Candidate, Sexual Function and Fertility Disorders
Conditions
Brief summary
Little is known about the effects of weight loss surgery on male reproductive health. This study will investigate the effect of bariatric surgery on male infertility by evaluating sexual health, blood hormone levels, and semen parameters before and after roux-en-y bariatric surgery.
Detailed description
Obesity is a worldwide epidemic that has numerous health consequences including male infertility. Prior studies have shown a variety of health benefits with bariatric surgery, including an improvement/resolution in diabetes and a significant improvement in serum testosterone levels. Based upon preliminary data from the literature, the investigators hypothesize that bariatric surgery is associated with a transient decrease followed by a robust long-term improvement in semen parameters including DNA fragmentation and oxidative stress. To test this hypothesis, the investigators propose a prospective observational study examining changes in hormone and semen parameters over the 12 months following Roux-en-Y gastric bypass surgery. The investigators will correlate these changes to weight loss, changes in subjective sexual function, and advanced semen parameters including DNA fragmentation. If successful, this study will conclusively identify a new modifiable cause for male infertility and suggest an additional medical indication for bariatric surgery in obese infertile men.
Interventions
DIAGNOSTIC_TESTSemen Analysis
Sperm counts will be determined by semen analysis.
DIAGNOSTIC_TESTHormonal panel
Blood test for LH, FSH, testosterone, and estradiol
PROCEDURERYGB Gastric Bypass
Roux-en-Y Gastric Bypass
DIAGNOSTIC_TESTIIEF Survey
International Index of Erectile Function is a validated 5-question survey examining sexual health in men
Sponsors
The Cleveland Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Men aged 18-55 * Undergoing Roux-en-Y bariatric surgery
Exclusion criteria
* History of undescended testes * Prior scrotal surgery * Known karyotypic abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sperm concentration | Baseline to 12 months | Changes in sperm concentration on semen analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sexual health | Baseline to 12 months | Change in International Index of Erectile Function (IIEF) score, a validated questionnaire with scores ranging from 1 (significant erectile dysfunction to 30 (no erectile dysfunction). |
| Changes in reproductive hormones | Baseline to 12 months | Changes in FSH, LH, testosterone, and estrogen blood levels |
| Weight loss | Baseline to 12 months | Change in weight following bariatric surgery |
| Changes in sperm morphology | Baseline to 12 months | Changes in percent normal sperm morphology on semen analysis |
| Changes in seminal DNA fragmentation | Baseline to 12 months | Changes in seminal DNA fragmentation rate on semen analysis |
| Changes in seminal oxidative stress | Baseline to 12 months | Changes in seminal reactive oxygen species |
Countries
United States
Outcome results
None listed