Influence of Ribavirin and Interferon o… | Clinical Trial

Key information

Conditions

Sperm Motility (Focus of Study) Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Erasmus M C, University Medical Center Rotterdam

Rotterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peginterferon alpha and ribavirin

Procedure

sperm collection

Sponsors and collaborators

Lead sponsor

Foundation for Liver Research

Other

Collaborators

Erasmus Medical Center

Registry information

Acronym: IRIS

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Apr 4, 2007
Registry last updated: Feb 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed