Zika VirusNCT02979938
Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection
An observational study of Zika Virus, run by Trinidad and Tobago IVF and Fertility Centre at 1 site in Trinidad and Tobago.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Zika Virus
- What is being tested?
- Semen analysis and semen PCR for Zika virus
- How many people
- 25 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- Jul 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Current urological malignancy
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
Trinidad and Tobago IVF & Fertility Centre
Maraval
About this study
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.
Read the 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
- estimating of the risk of sexual transmission of ZIKV in the general population
- antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus
- advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection
- strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART)
- advice on gamete cryopreservation
- optimising investigations for diagnosis of ZIKV in males.
- Conditions
- Zika Virus
- Being tested
- Semen analysis and semen PCR for Zika virus
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semen analysis and semen PCR for Zika virusOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the presence (with RT-PCR) of ZIKV in semen
Measured: 6 months
Secondary outcomes (1)
Measurement of the viral load (with ct values) of ZIKV in semen
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zika VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinidad and Tobago IVF and Fertility Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium
- Responsible party
- Sponsor
- Investigators
- Catherine Minto-Bain, MB ChB MRCOG, Principal investigator, Trinidad & Tobago IVF & Fertility Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979938
- Sponsor's protocol ID
- ZIKAFERTI
- Status last verified
- May 2018
- First submitted
- 17 Nov 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Excretion and Infectivity of Zika Virus in Semen During and After Infection
- ClinicalTrials.gov ID
- NCT02979938
- Acronym / sponsor ID
- ZIKAFERTI
- Conditions
- Zika Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Trinidad and Tobago IVF and Fertility CentreUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, Belgium
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- estimating of the risk of sexual transmission of ZIKV in the general population
- antenatal guidelines for the prevention of sexual transmission of ZIKV to the fetus
- advising couples on the length of time that pregnancy should be avoided in women wishing to conceive after their partner's ZIKV infection
- strategies to prevent transmission of ZIKV infection through assisted reproductive treatment (ART)
- advice on gamete cryopreservation
- optimising investigations for diagnosis of ZIKV in males.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Current urological malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semen analysis and semen PCR for Zika virusEvery 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. | Other | – |
Primary outcome
Measurement of the presence (with RT-PCR) of ZIKV in semen
Time frame: 6 months
1 secondary outcome
Measurement of the viral load (with ct values) of ZIKV in semen
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Minto-Bain, MB ChB MRCOG principal investigator
Trinidad & Tobago IVF & Fertility Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Zika Virus, run by Trinidad and Tobago IVF and Fertility Centre at 1 site in Trinidad and Tobago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Trinidad and Tobago. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the presence (with RT-PCR) of ZIKV in semen (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.