To assess short-term and long-term complications of mumps-associated orchitis in vaccinated men
ID
Source
Brief title
Condition
- Viral infectious disorders
- Male reproductive tract infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Semen quality during initial non-infective phase of mumps orchitis and
follow-up during at least 6 months period which can be lengthened if indicated.
Secondary outcome
Levels of FSH, LH, testosterone, SHBG and Inhibin B during the abovementioned 6
month period.
If possible hormone levels and semen quality after one year.
Background summary
Despite a successful vaccination programme over many years, mumps has
re-emerged. So far, outbreaks in fully vaccinated populations have been
concentrated among young adults with close social interactions. In the
Netherlands, an outbreak is ongoing since late 2009 among university students
in various towns.
Therefore, the RIVM/CIb convened an Outbreak Management Team (OMT) on January
31st 2011 to discuss the situation, to assess additional control options, and
to identify unresolved research questions. A major question is to improve
understanding of the long-term clinical outcome of mumps-associated orchitis in
vaccinated men with respect to their fertility.
Study objective
To assess short-term and long-term complications of mumps-associated orchitis
in vaccinated men
Study design
Observational study
Study burden and risks
Participating in this study does not cause any risks for the subjects. The
burden solely consists of the visits to the clinic and venapunctions.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
All men of 18 or more prospectively diagnosed with acute uni- or bilateral mumps-associated orchitis in the Netherlands after vaccination are eligible for inclusion.
Exclusion criteria
Exclusion criteria are the inability to ejaculate, the inability to provide written informed consent and risk factors in the medical history for decreased fertility (e.g. cancer, gonadal dysplasia, cryptorchidism etc).
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 | NL36899.018.11 |