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Pilot Study to Detect DENGUE Virus in Sperm

Pilot Study to Detect DENGUE Virus in Sperm.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03612609
Acronym
DENGSPERM
Enrollment
10
Registered
2018-08-02
Start date
2019-02-06
Completion date
2019-08-07
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue

Keywords

Dengue virus, Semen

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.

Interventions

BIOLOGICALblood, urine and semen sample

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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
dengue virus genomic RNA in patient sperm6 monthSearch for presence of dengue virus genomic RNA in patients sperm when they are in the acute phase of the infection with reverse transcriptase polymerase chain reaction

Countries

Reunion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026