- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02874456
Pilot Study to Detect Zika Virus in Sperm (ZIKSPERM)
Study Overview
Detailed Description
Since the end of 2015 an epidemic of ZIKA virus (ZIKV) infections is occurring in the Antilles-Guyana departments and focuses our attention on ZIKV and the risk of transmission during assisted reproductive technologies (ART). The importance of this epidemic and the presence in mainland of its mosquito vector (Aedes albopictus) point out the risk of a geographic extension of this infection. In this context the use of Medically Assisted Procreation leads to several questions when patients are infected. The question surges for patients (women and men) who live in epidemic areas but also for people who return from these regions and many other countries within the epidemic area (principally south and central America) and who need ART. Information about localization of ZIKV in the genital tract or shedding is poorly documented. Only two case reports detected ZIKV RNA in the semen and a sexual transmission was described. However, there is no data on the duration of the presence of ZIKV in semen and on localization of ZIKV in semen compartments (cells, seminal plasma, spermatozoa). The purpose of this study is to seek the presence of ZIKV in semen, to determine its localization and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.
This is a prospective study involving 15 patients, with acute ZIKV infection and a positive RNA detection in blood or/and urines (Institut Pasteur, Pointe-à-Pitre). Men will give semen, urine and blood specimens 7 days after the beginning of clinical signs and 11, 20, 30, 60 and 90 days after. ZIKV RNA being diagnosed with blood and/or urine sample positive for ZIKV RNA. ZIKV RNA will be detected in seminal plasma, native semen cells and processed spermatozoa. Semen sampling and processing will be performed within the ART laboratory of the hospital of Pointe-à-Pitre (Guadeloupe) and research of ZIKV RNA in the laboratory of Virology of Toulouse University Hospital. This study will identify the presence or absence of ZIKV seminal shedding and in case of shedding, verify the efficiency of semen processing to obtain virus free spermatozoa.
These results are important to understand the physiopathology of ZIKV infection and will help to define the management and viral safety procedures during Medically assisted Procreation in the context of ZIKV epidemic.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pointe-à-Pitre, Guadeloupe, 97159
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- infection by ZIKA virus in early stage
Exclusion Criteria:
- non infected male,
- erection problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: virus detection
detection of ZIKA virus in blood and sperm
|
Men will give semen, urine and blood specimens 7 days after the beginning of clinical signs and 11, 20, 30, 60 and 90 days after.
ZIKV RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
presence of Zika virus on RNA by polymerase chain reaction
Time Frame: 6 months
|
Presence or absence of ZIKV seminal shedding and in case of shedding, verify the efficiency of semen processing to obtain virus free spermatozoa.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Louis Bujan, MD PhD, University Hospital, Toulouse
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/16/7941
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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