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

Zika Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979938
• Other study ID #: ZIKAFERTI
• Status: Completed
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: Trinidad and Tobago IVF and Fertility Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Zika Virus
• Zika Virus Infection

Intervention

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.

Locations

Country	Name	City	State
Trinidad and Tobago	Trinidad and Tobago IVF & Fertility Centre	Maraval

Sponsors (2)

Lead Sponsor	Collaborator
Trinidad and Tobago IVF and Fertility Centre	Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Trinidad and Tobago, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the presence (with RT-PCR) of ZIKV in semen		6 months
Secondary	Measurement of the viral load (with ct values) of ZIKV in semen		6 months