The Effect of Bariatric Surgery on Spermatogenesis

NCT ID: NCT03725696

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-12-31

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.

Conditions

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Bariatric Surgery Candidate Sexual Function and Fertility Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Semen Analysis

Intervention Type DIAGNOSTIC_TEST

Sperm counts will be determined by semen analysis.

Hormonal panel

Intervention Type DIAGNOSTIC_TEST

Blood test for LH, FSH, testosterone, and estradiol

RYGB Gastric Bypass

Intervention Type PROCEDURE

Roux-en-Y Gastric Bypass

IIEF Survey

Intervention Type DIAGNOSTIC_TEST

International Index of Erectile Function is a validated 5-question survey examining sexual health in men

Interventions

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Semen Analysis

Sperm counts will be determined by semen analysis.

Intervention Type DIAGNOSTIC_TEST

Hormonal panel

Blood test for LH, FSH, testosterone, and estradiol

Intervention Type DIAGNOSTIC_TEST

RYGB Gastric Bypass

Roux-en-Y Gastric Bypass

Intervention Type PROCEDURE

IIEF Survey

International Index of Erectile Function is a validated 5-question survey examining sexual health in men

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Scott Lundy

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Lundy, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 16-721

Identifier Type: -

Identifier Source: org_study_id

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