Influence of Ribavirin and Interferon on Semen Quality, IRIS Study (IRIS)

February 28, 2012 updated by: Foundation for Liver Research
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus M C, University Medical Center Rotterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Liver Research

Collaborators

Erasmus Medical Center

Investigators

  • Principal Investigator: Robert J de Knegt, MD PhD, Foundation for Liver Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Estimate)

February 29, 2012

Last Update Submitted That Met QC Criteria

February 28, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRIS Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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