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Clinical Trials in France / NCT06983548
Starting soon Not applicable

Chikungunya Virus Detection in Semen

NCT06983548 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Toulouse
Phase
Not applicable
Started
2025-05
Last updated
2025-05-21

Condition(s) studied

Chikungunya Virus Infection

Investigational drug(s) / intervention(s)

semen, blood and urine tests

semen, blood and urine tests: 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).

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Number of Participants with Chikungunya virus genomic RNA in sperm — 6 months
    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)

Trial sites (2)

FacilityCityRegionStatus
CHU de Toulouse Toulouse Occitanie
CHU Réunion Saint-Pierre Réunion

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06983548 on ClinicalTrials.gov ↗ ← All trials in France