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

Completed

• Conditions: Zika Virus

• Registration Number: NCT02979938
• Lead Sponsor: Trinidad and Tobago IVF and Fertility Centre

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 Description

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-12-02
• Primary Completion: 2017-05
• Study Completion: 2017-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Male aged 18-50 years
• ZIKV symptoms within the preceding thirty days
• Confirmed ZIKV infection (WHO criteria)
• Able to ejaculate to produce a semen sample

Exclusion Criteria

• Current urological malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of the presence (with RT-PCR) of ZIKV in semen	6 months

Secondary Outcome Measures

Name	Time	Method
Measurement of the viral load (with ct values) of ZIKV in semen	6 months

Trial Locations

Locations (1)

Trinidad and Tobago IVF & Fertility Centre; 🇹🇹 Maraval, Trinidad and Tobago