Pilot Study to Detect Zika Virus in Sperm (ZIKSPERM)
Primary Purpose
Viruses
Status
Completed
Phase
Not Applicable
Locations
Guadeloupe
Study Type
Interventional
Intervention
virus detection
Sponsored by
About this trial
This is an interventional basic science trial for Viruses focused on measuring Zyca virus
Eligibility Criteria
Inclusion Criteria:
- infection by ZIKA virus in early stage
Exclusion Criteria:
- non infected male,
- erection problems
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
virus detection
Arm Description
detection of ZIKA virus in blood and sperm
Outcomes
Primary Outcome Measures
presence of Zika virus on RNA by polymerase chain reaction
Presence or absence of ZIKV seminal shedding and in case of shedding, verify the efficiency of semen processing to obtain virus free spermatozoa.
Secondary Outcome Measures
Full Information
NCT ID
NCT02874456
First Posted
May 6, 2016
Last Updated
November 9, 2020
Sponsor
University Hospital, Toulouse
Collaborators
Centre Hospitalier Universitaire de Pointe-a-Pitre, Institut Pasteur
1. Study Identification
Unique Protocol Identification Number
NCT02874456
Brief Title
Pilot Study to Detect Zika Virus in Sperm
Acronym
ZIKSPERM
Official Title
Pilot Study to Detect Zika Virus in Sperm
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 6, 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Centre Hospitalier Universitaire de Pointe-a-Pitre, Institut Pasteur
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viruses
Keywords
Zyca virus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
virus detection
Arm Type
Experimental
Arm Description
detection of ZIKA virus in blood and sperm
Intervention Type
Other
Intervention Name(s)
virus detection
Intervention Description
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.
Primary Outcome Measure Information:
Title
presence of Zika virus on RNA by polymerase chain reaction
Description
Presence or absence of ZIKV seminal shedding and in case of shedding, verify the efficiency of semen processing to obtain virus free spermatozoa.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infection by ZIKA virus in early stage
Exclusion Criteria:
non infected male,
erection problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Bujan, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Pointe-à-Pitre
ZIP/Postal Code
97159
Country
Guadeloupe
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28838639
Citation
Joguet G, Mansuy JM, Matusali G, Hamdi S, Walschaerts M, Pavili L, Guyomard S, Prisant N, Lamarre P, Dejucq-Rainsford N, Pasquier C, Bujan L. Effect of acute Zika virus infection on sperm and virus clearance in body fluids: a prospective observational study. Lancet Infect Dis. 2017 Nov;17(11):1200-1208. doi: 10.1016/S1473-3099(17)30444-9. Epub 2017 Aug 23.
Results Reference
result
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Pilot Study to Detect Zika Virus in Sperm
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