To study the effect of peginterferon alpha and ribavirin on spermatozoa
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
· Assess changes in sperm chromatin structure integrity, sperm concentration,
motility and morphology during ribavirin and peginterferon alpha treatment
Secondary outcome
· Asses if the changes in sperm due to treatment with ribavirin and
peginterferon alpha are reversible
· To assess changes in hormonal status in serum due to treatment with ribavirin
and peginterferon alpha .
Background summary
During and six months after treatment with peginterferon alpha and ribavirin
strict anticonception-use 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
Study objective
To study the effect of peginterferon alpha and ribavirin on spermatozoa
Study design
Single centre, observational pilot study
Study burden and risks
Burden: time investment (2-2,5 hours) and sampling semen en serum.
Risk: vena punction can cause slight pain, swelling and/or a infection, or a
bruise.
Benefit: more infromation on quality of sperm during and after treatment with
peginterferon alfa and ribavirin.
dr. molenwaterplein 40
3015 GD
Nederland
dr. molenwaterplein 40
3015 GD
Nederland
Listed location countries
Age
Inclusion criteria
written informed consent
Exclusion criteria
History of known shape and/or motility abnormalities of sperm.
- Concurrent use of drugs influencing sperm shape and motility
- Less then one million spermatozoa/ml in semen at screening
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11719.078.06 |