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

May 3, 2018 updated by: Trinidad and Tobago IVF and Fertility Centre
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of the presence (with RT-PCR) of ZIKV in semen
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of the viral load (with ct values) of ZIKV in semen
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trinidad and Tobago IVF and Fertility Centre

Collaborators

Institute of Tropical Medicine, Belgium

Investigators

  • Principal Investigator: Catherine Minto-Bain, MB ChB MRCOG, Trinidad & Tobago IVF & Fertility Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZIKAFERTI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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