Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-30 @ 10:03 PM
Study NCT ID:
NCT00455832
Status:
COMPLETED
Last Update Posted:
2012-02-29
First Post:
2007-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-28', 'studyFirstSubmitDate': '2007-04-02', 'studyFirstSubmitQcDate': '2007-04-03', 'lastUpdatePostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sperm chromatin structure integrity', 'sperm concentration', 'sperm motility', 'sperm morphology', 'peginterferon', 'ribavirin', 'hepatitis C'], 'conditions': ['Sperm Motility (Focus of Study)']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.', 'detailedDescription': '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.\n\nIn 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.\n\nAlso studies on the influence of ribavirin on sperm in human are lacking.\n\nThe aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa in men using these medication.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Treatment with peginterferon and ribavirin in the presence of a chronic Hepatitis C infection\n\nExclusion Criteria:\n\n* Preexisting semen abnormalities.\n* Concurrent use of drugs influencing sperm concentration,motility and morphology.\n* Less then one million spermatozoa/ml in semen at screening.'}, 'identificationModule': {'nctId': 'NCT00455832', 'acronym': 'IRIS', 'briefTitle': 'Influence of Ribavirin and Interferon on Semen Quality, IRIS Study', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Liver Research'}, 'officialTitle': 'Influence of Ribavirin and Interferon on Semen Quality, IRIS Study', 'orgStudyIdInfo': {'id': 'IRIS Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'peginterferon alpha and ribavirin', 'type': 'PROCEDURE', 'description': 'sperm collection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus M C, University Medical Center Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Robert J de Knegt, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foundation for Liver Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Liver Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}