Bariatric Surgery and Male Reproductive Function
Effect and Mechanism of Bariatric Surgery on Male Reproductive Function
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2019
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 11, 2021
March 1, 2021
1.7 years
December 25, 2019
March 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Semen quality assessment
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 Outcomes (10)
Concentration of interleukin in plasma
baseline- 3 months -6 months-12 months-2 years-3years
Change of body mass index Body constant
baseline- 3 months -6 months-12 months-2 years-3years
Changes of Vitamins
baseline- 3 months -6 months-12 months-2 years-3years
Changes of micronutrient
baseline- 3 months -6 months-12 months-2 years-3years
Changes of sex hormone
baseline- 3 months -6 months-12 months-2 years-3years
- +5 more secondary outcomes
Interventions
Laparoscopic sleeve gastrectomy is performed as following: after greater curvature dissociating, the gastric tube was calibrated over a 36F bougie and transection started approximately 5-6 cm from the pylorus toward the left diaphragmatic crus, using linear cutting stapler of 3.5- or 4.8-mm-high staples, depending on gastric thickness.
Laparoscopic Roux-en-Y gastric bypass is performed as following: a gastric pouch of approximately 30mL was obtained using linear cutting stapler, the sum of the length of the alimentary limb and the biliopancreatic limb\> 200 cm (can be adjusted according to the incidence of the patient's BMI, type 2 diabetes mellitus and the specific situation).
Eligibility Criteria
bariatric surgery male candidate
You may qualify if:
- Meet the surgical indications according to the Chinese Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes (2019 Edition).
- years old\< patient\<60 years old.
- Male
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Related Publications (1)
Gao X, Li P, Wang G, Li W, Song Z, Zhu S, Zhu L. Effect of laparoscopic sleeve gastrectomy on male reproductive function in Chinese men with obesity: a prospective cohort study. Int J Surg. 2024 Jun 1;110(6):3373-3381. doi: 10.1097/JS9.0000000000001328.
PMID: 38477110DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaihong Zhu, M.D.
Central South University Third Xiangya Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2019
First Posted
January 23, 2020
Study Start
May 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 1, 2023
Last Updated
March 11, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share