Clinical Trial: Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection

Brief Summary: 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.

Detailed Summary:

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

  1. estimating of the risk of sexual transmission of ZIKV in the general population
  2. antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus
  3. advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection
  4. strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART)
  5. advice on gamete cryopreservation
  6. optimising investigations for diagnosis of ZIKV in males.

Sponsor: Trinidad and Tobago IVF and Fertility Centre

Current Primary Outcome: Measurement of the presence (with RT-PCR) of ZIKV in semen [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Measurement of the viral load (with ct values) of ZIKV in semen [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Trinidad and Tobago IVF and Fertility Centre

Dates:
Date Received: November 17, 2016
Date Started: July 2016
Date Completion: August 2017
Last Updated: November 29, 2016
Last Verified: November 2016