Pilot Study to Detect Zika Virus in Sperm
Condition: Viruses
MeSH terms: Zika Virus Infection
Study type: Interventional

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.
    

Intervention name(s): virus detection
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Zyca virus