Male Factor in Early Recurrent Pregnancy Loss : Study of Sperm DNA Fragmentation in Patients With Unexplained Recurrent Pregnancy Loss.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- sperm DNA fragmentation
研究概览
简要总结
In human, 2% of couples experimented Recurrent pregnancy loss (RPL). Currently, while etiological investigations were performed, 40 to 50 % of RPL were unexplained. In animals' studies, several studies have underlined the importance of sperm quality for a normal embryo development. In human, epidemiological studies have demonstrated that several male risk factors have effects on development (male mediated development toxicology). However, few studies have explored sperm DNA fragmentation on embryo development but after in vitro fertilization. In natural pregnancy only rare studies have been performed but with different populations definitions and different methods of sperm exploration. In this context sperm DNA fragmentation exploration appears justified. The present study purpose to conduct a case - control study in order to research paternal role in RPL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Cases: Man from couples with RPL (more than 2 miscarriages) RPL classical etiological exploration negative (unexplained RPL) Healthy voluntaries
- •Control: Man from couples who have a child after a natural pregnancy obtained in the year following child desire.
- •Healthy voluntaries
排除标准
- •Cases: Etiological exploration of RPL positive Man with chromosomal anomaly
- •Cases and controls:
- •Ongoing pathology Chemotherapy or radiotherapy history Hyperthermia (fever) in the last three months Pregnancy obtained by assisted reproduction (Inseminations, in vitro fertilization) Women > 38 year old
研究组 & 干预措施
Cases
men from couples with RPL after natural pregnancies, had blood and sperm samples for sperm DNA fragmentation exploration
干预措施: Blood and sperm samples (Other)
Controls
men from couples who have a child consequently to a natural pregnancy, had blood and sperm samples for sperm DNA fragmentation exploration
干预措施: Blood and sperm samples (Other)
结局指标
主要结局
sperm DNA fragmentation
时间窗: baseline
Percentage of sperm with fragmented DNA in both groups
次要结局
- Sperm Volume(baseline)
- sperm concentration(baseline)
- Sperm aneuploidy(baseline)
- Sperm pH(baseline)
- percentage of motile and morphologically normal spermatozoa in sperm(baseline)
- sperm concentration of round cells(baseline)