Oxidative Stress, Vitamin E and Lipidomics in Seminal Fluid as Potential Link to Infertility
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oxysterol profiling in seminal fluid
研究概览
简要总结
Infertility is a common problem, affecting perhaps one couple in six, the majority of whom now seek medical care. It is becoming a social challenge because it is responsible for personal and interpersonal discomfort and anxiety. A major obstacle to meaningful study of the epidemiology of male infertility is the difficulty in accurate diagnosis of the presence or absence of a problem. Traditionally, the diagnosis of male infertility is facilitated by the conventional assessment of the semen profile - constructed according to recognized guidelines (i.e. WHO) and including pH, cell count and motility - but no specific biomarkers are available.
We sought to determine the oxysterol and fatty acid lipidome with the ai of finding a lipid biomarker useful for the diagnosis of male infertility.
详细描述
Subjects referring to an outpatient infertility laboratory will be enrolled in the study. A complete clinical record is collected as well as a sperm and a fasting blood sample. Patients are stratified according to current guidelines focusing on sperm and anatomical characteristics. Sperm characteristics will be studied on fresh samples immediately after collection; blood samples will be centrifuged and plasma stored at -80°C until analysis that include routine glucose and lipid profile by commercial kits. Vitamin E (alpha- and gamma-tocopherol), oxysterols profiling, and fatty acids profiling is analyzed by state of the art gas chromatography-mass spectrometry (GC/MS) using isotope dilution methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •clinically healthy subjects and clinical healthy subjects with infertility
排除标准
- •subjects with endocrine, cardiovascular, metabolic, inflammatory and neurologic diseases or cancer
- •subjects taking medicines and/or supplements
结局指标
主要结局
Oxysterol profiling in seminal fluid
时间窗: 1 day
Oxysterol profiling will be assessed in seminal fluid by state of the art GC/MS
次要结局
- Fatty acids lipidomics(1 day)
研究者
Luigi Iuliano
M.D.
University of Roma La Sapienza