NCT00455832

Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.

Detailed description

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.

Conditions

• Sperm Motility (Focus of Study)

Interventions

Type	Name	Description
PROCEDURE	peginterferon alpha and ribavirin	sperm collection

Timeline

• Start date: 2006-11-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2007-04-04
• Last updated: 2012-02-29

Locations

1 site across 1 country: Netherlands