Pilot Study to Detect DENGUE Virus in Sperm (DENGSPERM)
Primary Purpose
Dengue
Status
Completed
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
blood, urine and semen sample
Sponsored by
About this trial
This is an interventional basic science trial for Dengue focused on measuring Dengue virus, Semen
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
Sites / Locations
- Hôpital Saint-Pierre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
blood, urine and semen sample
Arm Description
15 patients, with acute dengue virus infection and a positive RNA detection in blood or/and urines
Outcomes
Primary Outcome Measures
dengue virus genomic RNA in patient sperm
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03612609
First Posted
July 27, 2018
Last Updated
August 21, 2019
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03612609
Brief Title
Pilot Study to Detect DENGUE Virus in Sperm
Acronym
DENGSPERM
Official Title
Pilot Study to Detect DENGUE Virus in Sperm.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
August 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
Keywords
Dengue virus, Semen
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
blood, urine and semen sample
Arm Type
Other
Arm Description
15 patients, with acute dengue virus infection and a positive RNA detection in blood or/and urines
Intervention Type
Biological
Intervention Name(s)
blood, urine and semen sample
Intervention Description
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.
Primary Outcome Measure Information:
Title
dengue virus genomic RNA in patient sperm
Description
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
Time Frame
6 month
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Bujan, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint-Pierre
City
Saint-Pierre
ZIP/Postal Code
97448
Country
Réunion
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26645066
Citation
Nedjadi T, El-Kafrawy S, Sohrab SS, Despres P, Damanhouri G, Azhar E. Tackling dengue fever: Current status and challenges. Virol J. 2015 Dec 9;12:212. doi: 10.1186/s12985-015-0444-8.
Results Reference
background
PubMed Identifier
25630344
Citation
Horstick O, Martinez E, Guzman MG, Martin JL, Ranzinger SR. WHO dengue case classification 2009 and its usefulness in practice: an expert consensus in the Americas. Pathog Glob Health. 2015 Feb;109(1):19-25. doi: 10.1179/2047773215Y.0000000003. Epub 2015 Jan 28.
Results Reference
background
PubMed Identifier
25928673
Citation
Horstick O, Tozan Y, Wilder-Smith A. Reviewing dengue: still a neglected tropical disease? PLoS Negl Trop Dis. 2015 Apr 30;9(4):e0003632. doi: 10.1371/journal.pntd.0003632. eCollection 2015 Apr.
Results Reference
background
PubMed Identifier
28902845
Citation
Tomashek KM, Lorenzi OD, Andujar-Perez DA, Torres-Velasquez BC, Hunsperger EA, Munoz-Jordan JL, Perez-Padilla J, Rivera A, Gonzalez-Zeno GE, Sharp TM, Galloway RL, Glass Elrod M, Mathis DL, Oberste MS, Nix WA, Henderson E, McQuiston J, Singleton J, Kato C, Garcia Gubern C, Santiago-Rivera W, Cruz-Correa J, Muns-Sosa R, Ortiz-Rivera JD, Jimenez G, Galarza IE, Horiuchi K, Margolis HS, Alvarado LI. Clinical and epidemiologic characteristics of dengue and other etiologic agents among patients with acute febrile illness, Puerto Rico, 2012-2015. PLoS Negl Trop Dis. 2017 Sep 13;11(9):e0005859. doi: 10.1371/journal.pntd.0005859. eCollection 2017 Sep.
Results Reference
background
PubMed Identifier
21994796
Citation
Chen R, Vasilakis N. Dengue--quo tu et quo vadis? Viruses. 2011 Sep;3(9):1562-608. doi: 10.3390/v3091562. Epub 2011 Sep 1.
Results Reference
background
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Pilot Study to Detect DENGUE Virus in Sperm
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