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Chikungunya Virus Detection in Semen

ConditionChikungunya Virus Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-45
SponsorUniversity Hospital, Toulouse

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • semen, blood and urine tests

    Biological/Vaccine

    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).

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Chikungunya virus-infected menOther 1 intervention

Trial outcomes

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)

Time frame
6 months

Secondary outcomes

1

Identification of the exact localization of Chikungunya genomic RNA in semen

polymerase chain reaction based identification of the exact localization of CHIKV genomic RNA, after centrifugation of semen aliquots to separate seminal plasma and seminal cells.

Time frame
6 months
2

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

Both unprocessed and prepared samples will be tested for the presence of Chikungunya virus RNA using validated real-time reverse transcription PCR (RT-PCR). By comparing the presence of CHIKV RNA before and after sperm preparation, the study aims to determine the capacity of these techniques to produce virus-free sperm. A negative result in the post-preparation sample indicates successful removal of the virus, supporting the potential use of ART in men previously infected with Chikungunya.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Agence de La Biomédecine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: