Clinical trial NCT03612609: Pilot Study to Detect DENGUE Virus in Sperm
Official title: Pilot Study to Detect DENGUE Virus in Sperm.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dengue
Keywords: Dengue virus
Semen
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to seek the presence of dengue virus 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 dengue virus infection and a positive RNA detection in blood or/and urines. These results are important to understand the physiopathology of dengue virus infection and will help to counsel the infected patient in epidemic zona or returning from epidemic country. Moreover, they will help to define the management and viral safety procedures during Medically assisted Procreation in the context of dengue virus epidemic

Detailed description: Dengue fever is a major cause of illness and death worldwide. The disease is caused by dengue virus (DENGV) which gets transmitted to humans by the bites of infected Aedes mosquitoes. The dengue virus is a flavivirus genus as for example the West Nile virus, yellow fever virus or Zika virus. In march 2018 a Dengue epidemic seems to start in La Reunion island.

dengue virus transmission occurs generally via the bite of the female mosquitoes while rare cases of non-vector transmission were reported. Only one case-report showed dengue virus in vaginal tract following dengue infection and any research was published about the links between male genital tract and dengue virus while a study revealed that 27 others viruses that can result in viremia have been found in human semen.

In this context, the purpose of this study is to seek the presence of dengue virus 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 dengue virus infection and a positive RNA detection in blood or/and urines. Men will give semen, urine and blood specimens 7 days after the beginning of clinical signs and 15, 30, 60 and 90 days after. Dengue virus RNA being diagnosed with blood and/or urine sample positive for dengue virus RNA. Dengue virus 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 University Hospital of La Reunion (St Pierre) and research of dengue virus RNA in the laboratory of Virology of Toulouse University Hospital. This study will identify the presence or absence of dengue virus seminal shedding, its dynamic, 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 dengue virus infection and will help to counsel the infected patient in epidemic zona or returning from epidemic country. Moreover, they will help to define the management and viral safety procedures during Medically assisted Procreation in the context of dengue virus epidemic.

Eligibility criteria: Inclusion Criteria:

* Patient male aged 18 to 45 years
* Patient in acute phase of dengue virus infection and with clinical criteria (date of onset of known clinical signs) which if thet aren't specific can be highly evocative in an epidemic zone. For example: Fever, asthenia, rash, arthritis/arthralgia, myalgia, headache, conjunctivitis.
* Detection of the dengue virus genome by reverse transcriptase polymerase chain reaction in the blood or urine
* Patient who can move to the laboratory for samples
* Patient having given his free and informed consent and having signed the consent
* Patient affiliated with a social security scheme or equivalent

Exclusion Criteria:

* Patient with an ejaculation disorder or who cannot sperm collection or with a sperm volume abnormal (\<1,5 ml).
* Patient under guardianship or under trusteeship
* Patient already included in a research protocol

Primary outcomes:
measure: dengue virus genomic RNA in patient sperm
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: Hôpital Saint-Pierre
Study officials:
affiliation: University Hospital, Toulouse
name: Louis Bujan, MD
role: PRINCIPAL_INVESTIGATOR
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