Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

Sperm Motility (Focus of Study) Clinical Trial

— IRIS  

Official title:

Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455832
• Other study ID #: IRIS Study
• Status: Completed
• Phase: N/A
• First received: April 2, 2007
• Last updated: February 28, 2012
• Start date: November 2006
• Est. completion date: July 2011

Study information

• Verified date: February 2012
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sperm Motility (Focus of Study)

Intervention

Procedure:
• peginterferon alpha and ribavirin
sperm collection

Locations

Country	Name	City	State
Netherlands	Erasmus M C, University Medical Center Rotterdam	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Liver Research	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands,