Chikungunya Virus Detection in Semen

NCT06983548 | Not Yet Recruiting

• 2 other identifiers: RC31/25/01862025-A00823-46
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Chikungunya is an arboviral disease transmitted by Aedes mosquitoes, present in intertropical zones and Europe. In August 2024, autochthonous cases appeared on Réunion, followed by a large epidemic. In March 2025, the incidence surpassed 2,000 cases per week. Due to a lack of data, the Haut Comité de Santé Publique issued an unfavorable opinion on using substances of human origin during the epidemic. Although the presence of Chikungunya virus genome in semen has been reported in 7 men, the incidence of viral excretion is unknown. This raises concerns about the risk of sexual transmission and infectivity, especially in assisted reproductive technologies. Previous studies on other arboviruses (Zika, dengue) have explored genital excretion. The goal of this prospective pilot study is to investigate Chikungunya virus presence and infectivity in semen, as well as to evaluate the effectiveness of sperm preparation methods in obtaining virus-free gametes. Fifteen patients with acute Chikungunya virus infection will provide blood, urine, and semen samples at different time points (7, 15, 30, 60, 90, and 180 days post-symptom onset). Seminal plasma, native sperm cells, and prepared sperm fractions will be tested for Chikungunya virus RNA at the University Hospital of La Réunion and Toulouse. This study will provide insights into viral excretion patterns and help improve the safety of medically assisted reproduction in epidemic situations.

Conditions

Chikungunya Virus Infection

Keywords

Chikungunya; semen analysis; viral excretion; RT-PCR

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Chikungunya virus genomic RNA in sperm

  Search for presence of Chikungunya virus genomic RNA in patients sperm when they are in the acute phase of the infection with reverse transcriptase polymerase chain reaction (RT-PCR)

  6 months

Secondary Outcomes (2)

• Identification of the exact localization of Chikungunya genomic RNA in semen

  6 months

• Validation of the efficacy of sperm preparation techniques to isolate Chikungunya-free sperm

  6 months

Study Arms (1)

Chikungunya virus-infected men

OTHER

Biological: semen, blood and urine tests

Interventions

semen, blood and urine tests BIOLOGICAL

Patients will undergo several tests, including semen analysis, spermocytogram, blood and urine tests, serology, and RT-PCR. These tests will be conducted on days 7±2, 15±2, 30±3, 60±5, 90±5, and 180±15. (Patients will only undergo the V6 if the sperm PCR result comes back positive on D90).

Chikungunya virus-infected men

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: this study aims to detect the presence of the Chikungunya virus in sperm, so only men can take part.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient aged 18 to 45 years.
• Patient in the acute phase of CHIKV infection, presenting clinical criteria (known onset of clinical symptoms) that, while not specific, can be highly suggestive in an epidemic area, such as: fever, fatigue, nausea, rash, arthritis/arthralgia, myalgia, headaches, conjunctivitis, and ocular pain.
• Detection of Chikungunya virus genome by Reverse Transcriptase polymerase chain reaction in blood or urine.
• Patient capable of traveling to the laboratory for sample collection.
• Patient who has given informed and voluntary consent and signed the consent form.
• Patient affiliated with a social security system or equivalent.

You may not qualify if:

• Patients with an ejaculation disorder, unable to provide a semen sample, or with an abnormal semen volume (\<1.5 mL).
• Patient with confirmed male infertility.
• Patients under judicial protection, guardianship, or curatorship.
• Patient already included in another research protocol.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Agence de La Biomédecine: collaborator

Study Sites (2)

CHU de Toulouse

Toulouse, Occitanie, 31300, France

Location

CHU Réunion

Saint-Pierre, Réunion, 97448, France

Location

MeSH Terms

Conditions

Chikungunya Fever

Interventions

Seeds; Blood Specimen Collection; Urinalysis

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Louis BUJAN

  University Hospital, Toulouse

  STUDY CHAIR

Central Study Contacts

Elie MOUANES ABELIN

CONTACT

05 67 77 10 07; mouanesabelin.e@chu-toulouse.fr

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: April 15, 2025
• First Posted: May 21, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)