<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02979938</url>
  </required_header>
  <id_info>
    <org_study_id>ZIKAFERTI</org_study_id>
    <nct_id>NCT02979938</nct_id>
  </id_info>
  <brief_title>Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection</brief_title>
  <official_title>Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trinidad and Tobago IVF and Fertility Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Trinidad and Tobago IVF and Fertility Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this prospective observational study the investigators will report on 20 male subjects&#xD;
      with proven WHO-classification Zika infection. These subjects will be followed up for a&#xD;
      maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV)&#xD;
      in semen over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective observational study the investigators will report on 20 male subjects&#xD;
      with proven WHO-classification Zika infection. These subjects will be followed up for a&#xD;
      maximum of 12 months to observe the presence, viral load and infectivity of Zika virus (ZIKV)&#xD;
      in semen over time.&#xD;
&#xD;
      Knowledge of the possible presence, infectivity and persistence of ZIKV in semen will provide&#xD;
      evidence-based data for&#xD;
&#xD;
        1. estimating of the risk of sexual transmission of ZIKV in the general population&#xD;
&#xD;
        2. antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus&#xD;
&#xD;
        3. advising couples on the length of time that pregnancy should be avoided in women wishing&#xD;
           to conceive after their partner's ZIKV infection&#xD;
&#xD;
        4. strategies to prevent transmission of ZIKV infection through assisted reproductive&#xD;
           treatment (ART)&#xD;
&#xD;
        5. advice on gamete cryopreservation&#xD;
&#xD;
        6. optimising investigations for diagnosis of ZIKV in males.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of the presence (with RT-PCR) of ZIKV in semen</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of the viral load (with ct values) of ZIKV in semen</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Zika Virus</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Semen analysis and semen PCR for Zika virus</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        25 men aged 18-50 years with ZIKV symptoms within the preceding thirty days &amp; confirmed&#xD;
        ZIKV infection (WHO criteria). The study setting is a private fertility clinic in Trinidad&#xD;
        and Tobago - a country with a current ZIKV epidemic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male aged 18-50 years&#xD;
&#xD;
          -  ZIKV symptoms within the preceding thirty days&#xD;
&#xD;
          -  Confirmed ZIKV infection (WHO criteria)&#xD;
&#xD;
          -  Able to ejaculate to produce a semen sample&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Current urological malignancy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Minto-Bain, MB ChB MRCOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Trinidad &amp; Tobago IVF &amp; Fertility Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Trinidad and Tobago IVF &amp; Fertility Centre</name>
      <address>
        <city>Maraval</city>
        <country>Trinidad and Tobago</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Trinidad and Tobago</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zika Virus Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979938
org study id: ZIKAFERTI
nct id: NCT02979938
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Measurement of the presence (with RT-PCR) of ZIKV in semen
time frame: 6 months
measure: Measurement of the viral load (with ct values) of ZIKV in semen
time frame: 6 months
intervention type: Other
intervention name: Semen analysis and semen PCR for Zika virus
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Catherine Minto-Bain, MB ChB MRCOG
role: Principal Investigator
affiliation: Trinidad & Tobago IVF & Fertility Centre
facility: 
country: Trinidad and Tobago
responsible party type: Sponsor
mesh term: Zika Virus Infection
sharing ipd: No