Influence of Ribavirin and Interferon on Semen Quality, IRIS Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sperm Motility (Focus of Study)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sperm chromatin structure integrity sperm concentration sperm motility sperm morphology peginterferon ribavirin hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

peginterferon alpha and ribavirin

sperm collection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert J de Knegt, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Foundation for Liver Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erasmus M C, University Medical Center Rotterdam

Rotterdam, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRIS Study

Identifier Type: -

Identifier Source: org_study_id