Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02979938
Recruitment Status : Completed
First Posted : December 2, 2016
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Zika Virus 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.

Layout table for study information
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 : July 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Measurement of the presence (with RT-PCR) of ZIKV in semen [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Measurement of the viral load (with ct values) of ZIKV in semen [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979938


Locations
Layout table for location information
Trinidad and Tobago
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
Layout table for investigator information
Principal Investigator: Catherine Minto-Bain, MB ChB MRCOG Trinidad & Tobago IVF & Fertility Centre

Layout table for additonal information
Responsible Party: Trinidad and Tobago IVF and Fertility Centre
ClinicalTrials.gov Identifier: NCT02979938     History of Changes
Other Study ID Numbers: ZIKAFERTI
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Zika Virus Infection
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections