Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
| Tracking Information | |||||
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| First Received Date ICMJE | April 2, 2007 | ||||
| Last Updated Date | February 28, 2012 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00455832 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Influence of Ribavirin and Interferon on Semen Quality, IRIS Study | ||||
| Official Title ICMJE | Influence of Ribavirin and Interferon on Semen Quality, IRIS Study | ||||
| Brief Summary | The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | primary care clinic |
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| Condition ICMJE | Sperm Motility (Focus of Study) | ||||
| Intervention ICMJE | Procedure: peginterferon alpha and ribavirin
sperm collection |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 23 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00455832 | ||||
| Other Study ID Numbers ICMJE | IRIS Study | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Foundation for Liver Research | ||||
| Study Sponsor ICMJE | Foundation for Liver Research | ||||
| Collaborators ICMJE | Erasmus Medical Center | ||||
| Investigators ICMJE |
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| Information Provided By | Foundation for Liver Research | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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