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

Sponsor
Trinidad and Tobago IVF and Fertility Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02979938
Collaborator
Institute of Tropical Medicine, Belgium (Other)
25
Enrollment
1
Location
13
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Semen analysis and semen PCR for Zika virus

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 Design

Study Type:
Observational
Actual Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Outcome Measures

Primary Outcome Measures

  1. Measurement of the presence (with RT-PCR) of ZIKV in semen [6 months]

Secondary Outcome Measures

  1. Measurement of the viral load (with ct values) of ZIKV in semen [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Trinidad and Tobago IVF & Fertility Centre Maraval Trinidad and Tobago

Sponsors and Collaborators

  • Trinidad and Tobago IVF and Fertility Centre
  • Institute of Tropical Medicine, Belgium

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Trinidad and Tobago IVF and Fertility Centre
ClinicalTrials.gov Identifier:
NCT02979938
Other Study ID Numbers:
  • ZIKAFERTI
First Posted:
Dec 2, 2016
Last Update Posted:
May 7, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Zika Virus Infection

Study Results

No Results Posted as of May 7, 2018