The Effect of Bariatric Surgery on Spermatogenesis

Terminated

• Conditions: Bariatric Surgery Candidate; Sexual Function and Fertility Disorders
• Interventions: Diagnostic Test: Semen Analysis; Diagnostic Test: Hormonal panel; Procedure: RYGB Gastric Bypass; Diagnostic Test: IIEF Survey

• Registration Number: NCT03725696
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2018-11-01
• Primary Completion: 2019-07-31
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Men aged 18-55
• Undergoing Roux-en-Y bariatric surgery

Exclusion Criteria

• History of undescended testes
• Prior scrotal surgery
• Known karyotypic abnormalities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group	Semen Analysis	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.
Observational group	Hormonal panel	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.
Observational group	IIEF Survey	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.
Observational group	RYGB Gastric Bypass	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.

Primary Outcome Measures

Name	Time	Method
Changes in sperm concentration	Baseline to 12 months	Changes in sperm concentration on semen analysis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States