Sperm Motility (Focus of Study)IRISNCT00455832
Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
An observational study of Sperm Motility (Focus of Study), run by Foundation for Liver Research at 1 site in Netherlands.
Trial summary
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Sperm Motility (Focus of Study)
- What is being tested?
- peginterferon alpha and ribavirin
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2006to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Written informed consent
- Treatment with peginterferon and ribavirin in the presence of a chronic Hepatitis C infection
Who cannot join
- Preexisting semen abnormalities.
- Concurrent use of drugs influencing sperm concentration,motility and morphology.
- Less then one million spermatozoa/ml in semen at screening.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus M C, University Medical Center Rotterdam
Rotterdam
About this study
The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.
Read the 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.
- Conditions
- Sperm Motility (Focus of Study)
- Being tested
- peginterferon alpha and ribavirin
- Keywords
- sperm chromatin structure integrity, sperm concentration, sperm motility, sperm morphology, peginterferon, ribavirin, hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon alpha and ribavirinProcedure or surgery
sperm collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startNov 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm Motility (Focus of Study)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Robert J de Knegt, MD PhD, Principal investigator, Foundation for Liver Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455832
- Sponsor's protocol ID
- IRIS Study
- Acronym
- IRIS
- Status last verified
- Feb 2012
- First submitted
- 2 Apr 2007
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
- ClinicalTrials.gov ID
- NCT00455832
- Acronym / sponsor ID
- IRIS / IRIS Study
- Conditions
- Sperm Motility (Focus of Study)
- Keywords
- sperm chromatin structure integrity, sperm concentration, sperm motility, sperm morphology, peginterferon, ribavirin, hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- Nov 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (2 listed)
- Written informed consent
- Treatment with peginterferon and ribavirin in the presence of a chronic Hepatitis C infection
Key exclusion criteria (3 listed)
- Preexisting semen abnormalities.
- Concurrent use of drugs influencing sperm concentration,motility and morphology.
- Less then one million spermatozoa/ml in semen at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peginterferon alpha and ribavirinsperm collection | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J de Knegt, MD PhD principal investigator
Foundation for Liver Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sperm Motility (Focus of Study), run by Foundation for Liver Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2012.