Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

Foundation for Liver Research

Status: Completed

Conditions: Sperm Motility (Focus of Study)

Treatments: Procedure: peginterferon alpha and ribavirin

Study type: Observational

Funder types: Other

Identifiers

NCT00455832

IRIS Study

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.