The Effect of Bariatric Surgery on Spermatogenesis

NeuroTherapia, Inc.

Status: Terminated

Conditions: Sexual Function and Fertility Disorders; Bariatric Surgery Candidate

Treatments: Diagnostic Test: Semen Analysis; Diagnostic Test: Hormonal panel; Diagnostic Test: IIEF Survey; Procedure: RYGB Gastric Bypass

Study type: Observational

Funder types: Other

Identifiers

NCT03725696

IRB 16-721

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

25 participants in 1 patient group

Observational group

Description:

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.

Treatment:

Diagnostic Test: Hormonal panel

Diagnostic Test: IIEF Survey

Procedure: RYGB Gastric Bypass

Diagnostic Test: Semen Analysis