Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study to Detect Zika Virus in Sperm (ZIKSPERM)

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: NCT02874456
Recruitment Status : Completed
First Posted : August 22, 2016
Last Update Posted : November 10, 2020
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Pointe-a-Pitre
Institut Pasteur
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Viruses Other: virus detection Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pilot Study to Detect Zika Virus in Sperm
Actual Study Start Date : May 6, 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Arm Intervention/treatment
Experimental: virus detection
detection of ZIKA virus in blood and sperm
Other: virus detection
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 Measures :
  1. 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.



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:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infection by ZIKA virus in early stage

Exclusion Criteria:

  • non infected male,
  • erection problems

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): NCT02874456


Locations
Layout table for location information
Guadeloupe
University Hospital
Pointe-à-Pitre, Guadeloupe, 97159
Sponsors and Collaborators
University Hospital, Toulouse
Centre Hospitalier Universitaire de Pointe-a-Pitre
Institut Pasteur
Investigators
Layout table for investigator information
Principal Investigator: Louis Bujan, MD PhD University Hospital, Toulouse
Publications of Results:
Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02874456    
Other Study ID Numbers: RC31/16/7941
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Zyca virus
Additional relevant MeSH terms:
Layout table for MeSH terms
Zika Virus Infection
Virus Diseases
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections