Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection
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|ClinicalTrials.gov Identifier: NCT02979938|
Recruitment Status : Completed
First Posted : December 2, 2016
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment|
|Zika Virus||Other: Semen analysis and semen PCR for Zika virus|
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
- estimating of the risk of sexual transmission of ZIKV in the general population
- antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus
- advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection
- strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART)
- advice on gamete cryopreservation
- optimising investigations for diagnosis of ZIKV in males.
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||August 2017|
- Other: Semen analysis and semen PCR for Zika virus
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.
- Measurement of the presence (with RT-PCR) of ZIKV in semen [ Time Frame: 6 months ]
- Measurement of the viral load (with ct values) of ZIKV in semen [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979938
|Trinidad and Tobago|
|Trinidad and Tobago IVF & Fertility Centre|
|Maraval, Trinidad and Tobago|
|Principal Investigator:||Catherine Minto-Bain, MB ChB MRCOG||Trinidad & Tobago IVF & Fertility Centre|