Pilot Study to Detect DENGUE Virus in Sperm

NCT03612609 | Completed

• 2 other identifiers: RC31/18/01332018-A01195-50
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Dengue

Keywords

Dengue virus; Semen

Outcome Measures

Primary Outcomes (1)

• 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

  6 month

Study Arms (1)

blood, urine and semen sample

OTHER

15 patients, with acute dengue virus infection and a positive RNA detection in blood or/and urines

Biological: blood, urine and semen sample

Interventions

blood, urine and semen sample BIOLOGICAL

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.

blood, urine and semen sample

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital Saint-Pierre

Saint-Pierre, 97448, Reunion

Location

Related Publications (6)

• 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.

  PMID: 26645066 BACKGROUND

• 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.

  PMID: 25630344 BACKGROUND

• 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.

  PMID: 25928673 BACKGROUND

• 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.

  PMID: 28902845 BACKGROUND

• 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.

  PMID: 21994796 BACKGROUND

• Mons J, Mahe-Poiron D, Mansuy JM, Lheureux H, Nigon D, Moinard N, Hamdi S, Pasquier C, Dejucq-Rainsford N, Bujan L. Effects of Acute Dengue Infection on Sperm and Virus Clearance in Body Fluids of Men. Emerg Infect Dis. 2022 Jun;28(6):1146-1153. doi: 10.3201/eid2806.212317.

  PMID: 35608553 RESULT

MeSH Terms

Conditions

Dengue

Interventions

Blood Specimen Collection; Urination

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Louis Bujan, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 2, 2018
• Study Start: February 6, 2019
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2019
• Last Updated: December 5, 2025

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1)