Pilot Study to Detect DENGUE Virus in Sperm (DENGSPERM)
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|ClinicalTrials.gov Identifier: NCT03612609|
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 22, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Dengue||Biological: blood, urine and semen sample||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Pilot Study to Detect DENGUE Virus in Sperm.|
|Actual Study Start Date :||February 6, 2019|
|Actual Primary Completion Date :||August 7, 2019|
|Actual Study Completion Date :||August 7, 2019|
blood, urine and semen sample
15 patients, with acute dengue virus infection and a positive RNA detection in blood or/and urines
Biological: blood, 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.
- dengue virus genomic RNA in patient sperm [ Time Frame: 6 month ]Search 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
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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): NCT03612609
|Saint-Pierre, Réunion, 97448|
|Principal Investigator:||Louis Bujan, MD||University Hospital, Toulouse|
|Responsible Party:||University Hospital, Toulouse|
|Other Study ID Numbers:||
2018-A01195-50 ( Other Identifier: ID RCB )
|First Posted:||August 2, 2018 Key Record Dates|
|Last Update Posted:||August 22, 2019|
|Last Verified:||August 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Vector Borne Diseases
RNA Virus Infections
Hemorrhagic Fevers, Viral