Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
研究概览
简要总结
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.
详细描述
During and six months after treatment with peginterferon alpha and ribavirin strict use of birth control is recommended (the producers advice two reliable forms) for both men and women because ribavirin has teratogenic and/or embryo-lethal effects in animal studies.
In cases of pregnancies during paternal exposure to peginterferon alpha and ribavirin elective termination of the pregnancy is usually recommended. However three cases of births after paternal exposure are reported with no birth defects. Cases of abnormalities after paternal exposure to ribavirin are lacking.
Also studies on the influence of ribavirin on sperm in human are lacking.
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa in men using these medication.
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 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Treatment with peginterferon and ribavirin in the presence of a chronic Hepatitis C infection
排除标准
- •Preexisting semen abnormalities.
- •Concurrent use of drugs influencing sperm concentration,motility and morphology.
- •Less then one million spermatozoa/ml in semen at screening.