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Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

This study has been completed.
Sponsor:
Collaborator:
Erasmus Medical Center
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00455832
First received: April 2, 2007
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention
Sperm Motility (Focus of Study)
 Procedure: peginterferon alpha and ribavirin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Foundation for Liver Research:

Enrollment: 23
Study Start Date: November 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: peginterferon alpha and ribavirin
    sperm collection
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455832

Locations
Netherlands
Erasmus M C, University Medical Center Rotterdam
Rotterdam, Netherlands
Sponsors and Collaborators
Foundation for Liver Research
Erasmus Medical Center
Investigators
Principal Investigator: Robert J de Knegt, MD PhD Foundation for Liver Research
  More Information

No publications provided

Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT00455832     History of Changes
Other Study ID Numbers: IRIS Study
Study First Received: April 2, 2007
Last Updated: February 28, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Foundation for Liver Research:
sperm chromatin structure integrity
sperm concentration
sperm motility
sperm morphology
 peginterferon
ribavirin
hepatitis C

Additional relevant MeSH terms:
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013