Bariatric Surgery and Male Reproductive Function

March 10, 2021 updated by: The Third Xiangya Hospital of Central South University

Effect and Mechanism of Bariatric Surgery on Male Reproductive Function

Obesity is a global public health problem. According to literature reports, as of 2016, China's obese population has reached more than 90 million and type 2 diabetes mellitus has reached more than 100 million, which has brought a serious health and economic burden to China. In addition to various health problems such as cardiovascular, osteoarthritis, and tumors, obesity can also cause abnormalities in reproductive endocrine. In women, it can cause abnormal menstruation, polycystic ovary syndrome, and male obesity can cause secondary gonadal. Hypofunction (MOSH). MOSH is an endocrine dysfunction. It is reported to have a prevalence of approximately 45% in moderate to severe obesity. In addition, studies have pointed out that the prevalence of hypogonadism in men with type 2 diabetes and obesity higher. However, there are no studies on the reproductive function of Chinese male patients after bariatric surgery. Pre- and post-operative semen will be collected for analysis to observe the effect of bariatric surgery on male reproductive function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
        • Sub-Investigator:
          • Pengzhou Li, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

bariatric surgery male candidate

Description

Inclusion Criteria:

  • Meet the surgical indications according to the Chinese Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes (2019 Edition).
  • 20 years old< patient<60 years old.
  • Male

Exclusion Criteria:

  • Incapacity of giving an informed consent.
  • Drug and / or alcohol abuse.
  • Scrotal injury and previous scrotal surgery.
  • Use of phosphodiesterase-5 inhibitors.
  • Mental illnesses that may affect compliance with clinical research, including dementia, active psychosis, major depression, or attempted suicide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semen quality assessment
Time Frame: 3 months after surgery
Semen quality assessment based the following indicators, including the time of liquefaction, semen PH, semen volume, sperm numbers, sperm vitality, sperm motility, sperm morphology, concentration of zinc in seminal plasma, concentration of fructose in seminal plasma, concentration of neutral α-glucosidase in seminal plasma, concentration of seminal elastase.The corresponding detection method is based on WHO laboratory manual for the Examination and processing of human semen(FIFTH EDITION).
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of interleukin in plasma
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
interleukin 6, interleukin 8, tumor necrosis factor-α
baseline- 3 months -6 months-12 months-2 years-3years
Change of body mass index Body constant
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
Body mass index=weight(kg)/ height(m2)
baseline- 3 months -6 months-12 months-2 years-3years
Changes of Vitamins
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
Vitamin A, Vitamin B1, Vitamin B2, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D. Folic acid; Vitamin E.
baseline- 3 months -6 months-12 months-2 years-3years
Changes of micronutrient
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
Copper, Zinc, Calcium, Magnesium, Iron, Selenium.
baseline- 3 months -6 months-12 months-2 years-3years
Changes of sex hormone
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
Testosterone, estradiol, luteinizing hormone, prolactin, follicle stimulating hormone, progesterone.
baseline- 3 months -6 months-12 months-2 years-3years
Changes of Blood lipids
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
High density lipoprotein; low density lipoprotein; cholesterol; triglyceride
baseline- 3 months -6 months-12 months-2 years-3years
Oral glucose tolerance test
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
glucose-0,30,120min; C peptide-0,30,120min; insulin-0,30,120min.
baseline- 3 months -6 months-12 months-2 years-3years
Changes in International Index of Erectile Function-5 scale scores
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
minimum point 0, maximum points 25, (≥22 points are normal, 17-21 mild Erectile dysfunction, 12-16 moderateErectile dysfunction, 8-11 moderate Erectile dysfunction, <7 severe Erectile dysfunction)
baseline- 3 months -6 months-12 months-2 years-3years
Changes Waist to hip ratio
Time Frame: baseline- 3 months -6 months-12 months-2 years-3years
Waist to hip ratio(WHR)=waist(cm)/hip(cm)
baseline- 3 months -6 months-12 months-2 years-3years
Semen quality assessment
Time Frame: baseline-6 months-12 months-2 years-3years
Semen quality assessment based the following indicators, including the time of liquefaction, semen PH, semen volume, sperm numbers, sperm vitality, sperm motility, sperm morphology, concentration of zinc in seminal plasma, concentration of fructose in seminal plasma, concentration of neutral α-glucosidase in seminal plasma, concentration of seminal elastase.The corresponding detection method is based on WHO laboratory manual for the Examination and processing of human semen(FIFTH EDITION).
baseline-6 months-12 months-2 years-3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Shaihong Zhu, M.D., Central South University Third Xiangya Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

January 19, 2020

First Posted (ACTUAL)

January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20191107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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