Microbiome Influence on Seminal Quality on Semen Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Seminal quality and microbiome
研究概览
简要总结
The microbiome plays an important role in health and in some unknown etiologies. Some previous studies have identified bacteria in semen as a potential factor in male infertility. More studies are needed to discover associations between microbiomes and semen quality. In this study, forty semen samples from donors candidates will be collected where clinical criteria for seminal quality (volume, concentration, motility and morphology) will be measured and bacterial communities examined. With the next-generation sequencing of gene technology and bioinformatic analysis, we can investigate the associations between bacterial communities and seminal quality. It would be interesting to know if the proportion of certain bacteria is significantly higher in samples of normal seminal quality or significantly higher in samples of low seminal quality. This study could contribute to the current understanding of certain etiologies of male fertility.
详细描述
Surplus semen samples will be collected from donor candidates who come to the IVI Alicante clinic with ages between 18 and 35 years old and who intend to participate in the donation program for the semen bank, and come to evaluate their quality. Informed consent for this study will be given to all of them, which they will have to return signed.
Depending on the semen quality evaluated in the diagnostic sample within the usual practice, in the laboratory the participants will be divided into 2 groups according to the WHO reference values in terms of sperm concentration and percentage of progressive motility:
- Group A (Normozoospermics): ≥15 mill / ml and> 32% progressive mobility.
- Group B (Non-normozoospermic): <15 mill / ml and <32% progressive mobility. The study will consist of 2 years. The first year will be used to collect all the diagnostic seminal samples from donor candidates, and the second year will be used in its first months to analyze the microbiome by extracting DNA from ejaculates, amplifying bacterial DNA with targeted primers. to the bacterial 16S rRNA gene regions, sequencing, library preparation and bioinformatic analysis.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-35 years. Suitable on your first informational visit.
排除标准
- •Presence of own or hereditary pathology. Presence of mental or behavioral disturbance
结局指标
主要结局
Seminal quality and microbiome
时间窗: Two years
Evaluate the bacterial composition of semen in a given population (sperm donor) analyzing the microbiome by extracting DNA from ejaculates, amplifying bacterial DNA with targeted primers to the bacterial 16S rRNA gene regions, sequencing, library preparation and bioinformatic analysis.
次要结局
- Microbiome and individual semen quality parameters Microbiome as a fertility biomarker(seven months)