Influence of Ribavirin and Interferon on Semen Quality, IRIS Study (IRIS)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Influence of Ribavirin and Interferon on Semen Quality, IRIS Study|
|Study Start Date:||November 2006|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Procedure: peginterferon alpha and ribavirin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455832
|Erasmus M C, University Medical Center Rotterdam|
|Principal Investigator:||Robert J de Knegt, MD PhD||Foundation for Liver Research|