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Pilot Study to Detect DENGUE Virus in Sperm (DENGSPERM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03612609
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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

Condition or disease Intervention/treatment Phase
Dengue Biological: blood, urine and semen sample Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Réunion
Hôpital Saint-Pierre
Saint-Pierre, Réunion, 97448
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Louis Bujan, MD University Hospital, Toulouse
More Information
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Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03612609    
Other Study ID Numbers: RC31/18/0133
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Dengue virus
Semen
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral