The Effect of Bariatric Surgery on Spermatogenesis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational group Patients who are booked for RYGB gastric bypass surgery and enroll in the study will undergo semen analysis, sexual health questionnaire (IIEF survey), and a blood hormonal panel before and after surgery. |
Diagnostic Test: Semen Analysis
Sperm counts will be determined by semen analysis.
Diagnostic Test: Hormonal panel
Blood test for LH, FSH, testosterone, and estradiol
Procedure: RYGB Gastric Bypass
Roux-en-Y Gastric Bypass
Diagnostic Test: IIEF Survey
International Index of Erectile Function is a validated 5-question survey examining sexual health in men
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Outcome Measures
Primary Outcome Measures
- Changes in sperm concentration [Baseline to 12 months]
Changes in sperm concentration on semen analysis
Secondary Outcome Measures
- Weight loss [Baseline to 12 months]
Change in weight following bariatric surgery
- 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
- Changes in seminal oxidative stress [Baseline to 12 months]
Changes in seminal reactive oxygen species
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men aged 18-55
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Undergoing Roux-en-Y bariatric surgery
Exclusion Criteria:
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History of undescended testes
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Prior scrotal surgery
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Known karyotypic abnormalities
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- The Cleveland Clinic
Investigators
- Principal Investigator: Scott Lundy, MD PhD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB 16-721