NCT01842295已完成不适用
Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Number of total spermatozoids (NTS) variation
研究概览
简要总结
The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men.
详细描述
In order to assess how bariatric surgery may influence their fertility parameters, patients will attend to 3 visits :
First visit (inclusion, before surgery) :
- Signature of consent
- Patient interview (Collection of data on background, treatments, socio-demographic characteristics, social and familial environment, food consumption and habits, tobacco and alcohol use, physical activity, libido and quality of life (surveys))
- Clinical examination and anthropometric assessment (BMI, blood pressure, expired CO)
- Blood samples (Metabolic and nutritional plasmatic biomarkers ; Plasmatic oxidative stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation ; sex hormones ; persistent contaminants)
- Sperm sample (sperm count-morphology ; DNA fragmentation ; CASA)
Bariatric surgery
Second visit (6 month follow-up)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Obese men with BMI ≥ 40kg/m² or 35 kg/m² with associated co-morbidities
- •Selected for bariatric surgery by multidisciplinary team
- •From 18 to 50 years old included
- •With a first medical consultation and its results
- •With their written informed consent to participate in the study
- •No problem for understanding verbal or written French
- •An affiliation to social security
排除标准
- •Not candidates for surgery
- •With non idiopathic alteration of spermatogenesis
研究组 & 干预措施
Bariatric surgery
No Intervention
Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team
干预措施: Blood and sperm samples (Other)
结局指标
主要结局
Number of total spermatozoids (NTS) variation
时间窗: 6 months after surgery
Comparison before/after surgery
次要结局
- Evaluation of environmental parameters : quality of life(6 months and 1 year after surgery)
- Number of total spermatozoids (NTS) variation(1 year after surgery)
- Effect of biological parameters on NTS variation(6 months and 1 year after surgery)
- Other spermatic parameters : DNA fragmentation(6 months and 1 year after surgery)
- Evaluation of environmental parameters : libido(6 months and 1 year after surgery)
- Evaluation of environmental parameters : physical activity(6 months and 1 year after surgery)
- Other spermatic parameters : CASA(6 months and 1 year after surgery)
- Effect of anthropometric parameters on NTS variation(6 months and 1 year after surgery)
- sperm caracteristics(6 months and 1 year after surgery)
- Evaluation of environmental parameters : tobacco consumption(6 months and 1 year after surgery)
研究者
研究点 (2)
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