Chikungunya Virus InfectionCHIKSPERMNCT06983548
Chikungunya Virus Detection in Semen
A study testing semen, blood and urine tests in people with Chikungunya Virus Infection, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Chikungunya Virus Infection
- What is being tested?
- semen, blood and urine tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- May 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHU Réunion
Saint-Pierre, Réunion, 97448
Hélène LHEUREUX, 02 62 35 90 00, helene.lheureux@chu-reunion.fr
CHU de Toulouse
Toulouse, Occitanie, 31300
Elie MOUANES ABELIN, 05 67 77 10 07 ext. +33, mouanesabelin.e@chu-toulouse.fr
About this study
Official title: Chikungunya Virus Detection in Semen: Preliminary Study - CHIKSPERM
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.
Read more
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.
Read the detailed description
Chikungunya is an arbovirosis transmitted by mosquitoes of the genus Aedes. These vectors are present in intertropical zones, but have also been present in Europe for several years. The chikungunya virus (CHIKV) is a virus of the Alphavirus genus and the Togaviridae family. In mid-August 2024, autochthonous cases of chikungunya appeared on Réunion, followed by a vast epidemic, leading to the activation of a level 3 ORSEC plan, then level 4 in March 2025. At this time, the incidence was over 2,000 cases per week. In the absence of data, and as a precaution, the Haut Comité de Santé Publique issued an unfavourable opinion on the use of substances of human origin during the 2025 epidemic. Epidemics seem to recur in intertropical zones and could emerge in mainland France due to the presence of a vector (Ae. albopictus).
At present, only two case studies have reported the presence of the CHIKV genome in the semen of 7 men, but the incidence of positive semen in infected men is unknown. This genital excretion has already been described for other arboviruses belonging to the Flaviviridae family, such as Zika fever and dengue fever.
The possibility of detecting the CHIKV genome in semen raises questions about its frequency and kinetics, the infectivity of the virus and the risk of sexual transmission of the virus or during assisted reproductive technologies. It is therefore essential to: 1) understand the kinetics of viral excretion in semen and urine compared with the viremia used to diagnose infection, 2) study the fractions of semen containing viral genomes and 3) investigate possible infectivity (seminal plasma, native sperm cells, spermatozoa). We benefit from the experience of pilot studies carried out under the same conditions on other viruses (HIV, HCV, ZIKV, DENV SARS-CoV-2).
The aim of this project, carried out within teams involved in the virus and reproduction theme, is to investigate the presence of the CHIKUNGUNYA virus in sperm (genome and infectivity), to specify its location, and to study the effectiveness of conventional sperm preparation methods in obtaining virus-free gametes.
This is a prospective, pilot study involving 15 patients in the acute phase of infection with positive CHIKV RNA detection in blood and/or urine. Blood, urine and semen samples will be taken 7 days after the onset of clinical signs and 15, 30, 60, 90 and 180 days later.
In the genital compartment, CHIKV RNA will be tested in seminal plasma, in native sperm cells and in cell fractions obtained after sperm preparation. The semen will be processed at the Reproduction Centre of the University Hospital of La Réunion, and the CHIKV RNA will be tested in the different aliquots in the virology laboratory of the University Hospital of Toulouse.
This study will make it possible to determine the frequency of viral excretion in the semen and to determine how this changes during the course of the infection. The study of seminal fractions will make it possible to monitor the efficiency of sperm preparation methods in obtaining virus-free spermatozoa. In addition to the pathophysiological knowledge that this study will provide, the results will help to define the appropriate course of action and improve the viral safety of medically assisted reproduction in epidemic situations and for patients returning from epidemic areas.
- Conditions
- Chikungunya Virus Infection
- Being tested
- semen, blood and urine tests
- Keywords
- Chikungunya, semen analysis, viral excretion, RT-PCR
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semen, blood and urine testsBiological
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 group | Role | What they receive |
|---|---|---|
| Chikungunya virus-infected men | Other | Not described Receives: Biological: semen, blood and urine tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startMay 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine
- Responsible party
- Sponsor
- Investigators
- Louis BUJAN, Study chair, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983548
- Sponsor's protocol ID
- RC31/25/0186
- Other IDs
- 2025-A00823-46
- Acronym
- CHIKSPERM
- Status last verified
- May 2025
- First submitted
- 15 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chikungunya Virus Detection in Semen: Preliminary Study - CHIKSPERM
- ClinicalTrials.gov ID
- NCT06983548
- Acronym / sponsor ID
- CHIKSPERM / RC31/25/0186
- Conditions
- Chikungunya Virus Infection
- Keywords
- Chikungunya, semen analysis, viral excretion, RT-PCR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine
- Study start
- May 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chikungunya is an arbovirosis transmitted by mosquitoes of the genus Aedes. These vectors are present in intertropical zones, but have also been present in Europe for several years. The chikungunya virus (CHIKV) is a virus of the Alphavirus genus and the Togaviridae family. In mid-August 2024, autochthonous cases of chikungunya appeared on Réunion, followed by a vast epidemic, leading to the activation of a level 3 ORSEC plan, then level 4 in March 2025. At this time, the incidence was over 2,000 cases per week. In the absence of data, and as a precaution, the Haut Comité de Santé Publique issued an unfavourable opinion on the use of substances of human origin during the 2025 epidemic. Epidemics seem to recur in intertropical zones and could emerge in mainland France due to the presence of a vector (Ae. albopictus).
At present, only two case studies have reported the presence of the CHIKV genome in the semen of 7 men, but the incidence of positive semen in infected men is unknown. This genital excretion has already been described for other arboviruses belonging to the Flaviviridae family, such as Zika fever and dengue fever.
The possibility of detecting the CHIKV genome in semen raises questions about its frequency and kinetics, the infectivity of the virus and the risk of sexual transmission of the virus or during assisted reproductive technologies. It is therefore essential to: 1) understand the kinetics of viral excretion in semen and urine compared with the viremia used to diagnose infection, 2) study the fractions of semen containing viral genomes and 3) investigate possible infectivity (seminal plasma, native sperm cells, spermatozoa). We benefit from the experience of pilot studies carried out under the same conditions on other viruses (HIV, HCV, ZIKV, DENV SARS-CoV-2).
The aim of this project, carried out within teams involved in the virus and reproduction theme, is to investigate the presence of the CHIKUNGUNYA virus in sperm (genome and infectivity), to specify its location, and to study the effectiveness of conventional sperm preparation methods in obtaining virus-free gametes.
This is a prospective, pilot study involving 15 patients in the acute phase of infection with positive CHIKV RNA detection in blood and/or urine. Blood, urine and semen samples will be taken 7 days after the onset of clinical signs and 15, 30, 60, 90 and 180 days later.
In the genital compartment, CHIKV RNA will be tested in seminal plasma, in native sperm cells and in cell fractions obtained after sperm preparation. The semen will be processed at the Reproduction Centre of the University Hospital of La Réunion, and the CHIKV RNA will be tested in the different aliquots in the virology laboratory of the University Hospital of Toulouse.
This study will make it possible to determine the frequency of viral excretion in the semen and to determine how this changes during the course of the infection. The study of seminal fractions will make it possible to monitor the efficiency of sperm preparation methods in obtaining virus-free spermatozoa. In addition to the pathophysiological knowledge that this study will provide, the results will help to define the appropriate course of action and improve the viral safety of medically assisted reproduction in epidemic situations and for patients returning from epidemic areas.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chikungunya virus-infected men | Other | Biological: semen, blood and urine tests |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semen, blood and urine testsPatients 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). | Biological | Chikungunya virus-infected men |
Primary outcome
Number of Participants with Chikungunya virus genomic RNA in sperm
Time frame: 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)
2 secondary outcomes
Identification of the exact localization of Chikungunya genomic RNA in semen
Time frame: 6 months
Validation of the efficacy of sperm preparation techniques to isolate Chikungunya-free sperm
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
Related trials for Chikungunya Virus Infection
RecruitingPhase 4
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
Chikungunya Virus Infection
Recruiting
Against Chikungunya Virus and Neonatal Infection
Chikungunya Virus Infection, Neonatal
Active, not recruitingPhase 3
Long-term Follow-up Study to Evaluate Safety and Immunogenicity of CHIKV VLP Single or Booster Vaccination
Chikungunya Virus Infection
Active, not recruitingObservational study
Prospective Safety Cohort Study After VLA1553 Vaccination in Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil
Chikungunya Virus Infection
Enrolling by invitationObservational study
VLA1553-403 Pregnancy Surveillance Study
Chikungunya Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis BUJAN study chair
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semen, blood and urine tests in people with Chikungunya Virus Infection, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elie MOUANES ABELIN (05 67 77 10 07 ext. +33, mouanesabelin.e@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Chikungunya virus genomic RNA in sperm (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025; AzTrials last refreshed its copy on 31 Oct 2026.