Sperm Motility (Focus of Study)
Conditions
Keywords
sperm chromatin structure integrity, sperm concentration, sperm motility, sperm morphology, peginterferon, ribavirin, hepatitis C
Brief summary
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.
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.
Interventions
PROCEDUREpeginterferon alpha and ribavirin
sperm collection
Sponsors
Erasmus Medical Center
Foundation for Liver Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Countries
Netherlands
Outcome results
None listed