Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

Foundation for Liver Research23 enrolled

Overview

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

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

Enrollment

Conditions

Sperm Motility (Focus of Study)

Interventions

peginterferon alpha and ribavirinPROCEDURE

sperm collection

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent * Treatment with peginterferon and ribavirin in the presence of a chronic Hepatitis C infection Exclusion Criteria: * Preexisting semen abnormalities. * Concurrent use of drugs influencing sperm concentration,motility and morphology. * Less then one million spermatozoa/ml in semen at screening.

Locations (1)

Erasmus M C, University Medical Center Rotterdam

Rotterdam, Netherlands

Data from ClinicalTrials.gov

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