Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02874456 |
| Other study ID # |
RC31/16/7941 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 6, 2016 |
| Est. completion date |
December 2017 |
Study information
| Verified date |
November 2020 |
| Source |
University Hospital, Toulouse |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
