Effect and Mechanism of Bariatric Surgery on Male Reproductive Function
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Semen quality assessment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Semen quality assessment
时间窗: 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).
次要结局
- Change of body mass index Body constant(baseline- 3 months -6 months-12 months-2 years-3years)
- Changes of sex hormone(baseline- 3 months -6 months-12 months-2 years-3years)
- Semen quality assessment(baseline-6 months-12 months-2 years-3years)
- Concentration of interleukin in plasma(baseline- 3 months -6 months-12 months-2 years-3years)
- Changes of Vitamins(baseline- 3 months -6 months-12 months-2 years-3years)
- Changes Waist to hip ratio(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 Blood lipids(baseline- 3 months -6 months-12 months-2 years-3years)
- Oral glucose tolerance test(baseline- 3 months -6 months-12 months-2 years-3years)
- Changes in International Index of Erectile Function-5 scale scores(baseline- 3 months -6 months-12 months-2 years-3years)