The Effect of Bariatric Surgery on Spermatogenesis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Bariatric Surgery on Spermatogenesis

Conditions
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Bariatric Surgery Candidate, Sexual Function and Fertility Disorders

Intervention / Treatment
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* Diagnostic Test: Semen Analysis
* Diagnostic Test: Hormonal panel
* Procedure: RYGB Gastric Bypass
* Diagnostic Test: IIEF Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 18-55 Undergoing Roux-en-Y bariatric surgery Exclusion Criteria: History of undescended testes Prior scrotal surgery Known karyotypic abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational group<br>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<br>* Sperm counts will be determined by semen analysis.<br>Diagnostic Test: Hormonal panel<br>* Blood test for LH, FSH, testosterone, and estradiol<br>Procedure: RYGB Gastric Bypass<br>* Roux-en-Y Gastric Bypass<br>Diagnostic Test: IIEF Survey<br>* International Index of Erectile Function is a validated 5-question survey examining sexual health in men<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sperm concentration | Changes in sperm concentration on semen analysis | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Change in weight following bariatric surgery | Baseline to 12 months | 
| Changes in sexual health | 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). | Baseline to 12 months | 
| Changes in reproductive hormones | Changes in FSH, LH, testosterone, and estrogen blood levels | Baseline to 12 months | 
| Changes in seminal oxidative stress | Changes in seminal reactive oxygen species | Baseline to 12 months | 
| Changes in sperm morphology | Changes in percent normal sperm morphology on semen analysis | Baseline to 12 months | 
| Changes in seminal DNA fragmentation | Changes in seminal DNA fragmentation rate on semen analysis | Baseline to 12 months |