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| Name | Class |
|---|---|
| Institute of Tropical Medicine, Belgium | OTHER |
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In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.
In this prospective observational study the investigators will report on 20 male subjects with proven WHO-classification Zika infection. These subjects will be followed up for a maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV) in semen over time.
Knowledge of the possible presence, infectivity and persistence of ZIKV in semen will provide evidence-based data for
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semen analysis and semen PCR for Zika virus | Other | Every two weeks subjects provide a semen sample which is analysed and then frozen for RT-PCR and viral load. Semen sample testing for the presence of ZIKV (Institute of Tropical Medicine, Belgium) will be performed using both a ZIKV-specific, in-house duplex real-time RT-PCR, targeting a 102bp and 121bp sequence of the NS5 gene and the RealStar® Zika Virus RT-PCR Kit (Altona). Quantitative viral load RNA measurements will be expressed utilizing threshold cycle values because a standardized viral load reference method is not available. To test for infectivity of ZIKV in semen, ZIKV isolation will be attempted in semen samples with a high viral ZIKV load (i.e. positive ZIKV PCR result and Ct-values below 30) by inoculation in Vero cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the presence (with RT-PCR) of ZIKV in semen | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the viral load (with ct values) of ZIKV in semen | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
• Current urological malignancy
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25 men aged 18-50 years with ZIKV symptoms within the preceding thirty days & confirmed ZIKV infection (WHO criteria). The study setting is a private fertility clinic in Trinidad and Tobago - a country with a current ZIKV epidemic.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Minto-Bain, MB ChB MRCOG | Trinidad & Tobago IVF & Fertility Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trinidad and Tobago IVF & Fertility Centre | Maraval | Trinidad and Tobago |
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| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| D055101 | Semen Analysis |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |