Influence of Ribavirin and Interferon on Semen Quality, IRIS Study (IRIS)
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|ClinicalTrials.gov Identifier: NCT00455832|
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : February 29, 2012
|Condition or disease||Intervention/treatment|
|Sperm Motility (Focus of Study)||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.
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|Official Title:||Influence of Ribavirin and Interferon on Semen Quality, IRIS Study|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Procedure: peginterferon alpha and ribavirin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455832
|Erasmus M C, University Medical Center Rotterdam|
|Principal Investigator:||Robert J de Knegt, MD PhD||Foundation for Liver Research|