Cytomegalovirus InfectionsMyCMVNCT06694428
Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
An observational study of Cytomegalovirus Infections and Maternal Primary Cytomegalovirus Infection, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Congenital cytomegalovirus (CMV) infection is the most common congenital infection with a birth prevalence of 0.4% in Europe. It is the leading non-genetic cause of sensorineural hearing loss and a major cause of neurodevelopmental disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cytomegalovirus Infections, Maternal Primary Cytomegalovirus Infection
- What is being tested?
- Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed
- How many people
- 491 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Apr 2025to 4 Apr 2027
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with prescription of a CMV serology including the search for CMV IgG and IgM antibodies, care at the Necker-Enfants Malades or Paul Brousse hospitals or CHU Limoges, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known.
Who may be able to join
- Pregnant woman
- And for whom a CMV serology including the search for CMV IgG and IgM antibodies is prescribed at the Necker-Enfants Malades or Paul Brousse hospital or CHU Limoges
- And with positive anti-CMV IgM or in the grey zone of the technique
- And for whom the date of start of pregnancy is known
- And who does not object to the use of their data in the context of this research
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU de Limoges
Limoges, 87000
Sophie Alain, MD, PhD, 0555056724 ext. +33, sophie.alain@unilim.fr
Mafi Sarah
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Jacques Fourgeaud, Pharm.D., PhD, 0033144495611, jacques.fourgeaud@aphp.fr
Yves Ville, M.D., PhD, 0033171196482, yves.ville@aphp.fr
- Recruiting
Hôpital Paul Brousse
Villejuif, 94804
Coralie Kerestedjian Pallier, M.D., PhD, 003345593342, coralie.pallier@aphp.fr
Christelle Vauloup-Fellous, M.D., PhD, 003345593314, christelle.vauloup-fellous@aphp.fr
About this study
Congenital cytomegalovirus (CMV) infection is the most common congenital infection with a birth prevalence of 0.4% in Europe. It is the leading non-genetic cause of sensorineural hearing loss and a major cause of neurodevelopmental disabilities. The risk of intrauterine transmission is highest when primary infection occurs during pregnancy. Primary CMV infection is asymptomatic or causes non-specific symptoms and only serology can diagnose it with certainty.
The diagnosis of CMV infection is based on the combination of 2 or 3 serological markers and the interpretation of the results is more complex than for other infections and may require additional analyses and sometimes delay the diagnosis and the implementation of secondary prevention of CMV transmission to the fetus by the administration of valaciclovir. Indeed, the effectiveness of secondary prevention is conditioned by the early administration of treatment after the maternal primary infection.
Read more
The National Reference Center for Congenital CMV Infections at Necker Hospital, in collaboration with the virology laboratory at Paul Brousse Hospital, has developed the MyCMV "expert" tool, which is a decision-making algorithm that allows the interpretation of CMV serology and CMV PCR results.
The hypothesis of the study is that the use and provision of this MyCMV "expert" tool to health professionals (biologists, midwives and obstetricians) for the interpretation of virological results could avoid a delay in diagnosis and would allow patients to be referred more quickly to a prenatal diagnosis center for appropriate management of CMV infection.
The aim of the study is to evaluate the rate of detection of primary CMV infection in the first trimester of pregnancy using the MyCMV tool compared with the reference method (results interpreted by the centre's expert investigator).
Read the detailed description
Congenital cytomegalovirus (CMV) infection is the most common congenital infection with a birth prevalence of 0.4% in Europe. It is the leading non-genetic cause of sensorineural hearing loss and a major cause of neurodevelopmental disabilities. The risk of intrauterine transmission is highest when primary infection occurs during pregnancy. Primary CMV infection is asymptomatic or causes non-specific symptoms and only serology can diagnose it with certainty.
The diagnosis of CMV infection is based on the combination of 2 or 3 serological markers and the interpretation of the results is more complex than for other infections and may require additional analyses and sometimes delay the diagnosis and the implementation of secondary prevention of CMV transmission to the fetus by the administration of valaciclovir. Indeed, the effectiveness of secondary prevention is conditioned by the early administration of treatment after the maternal primary infection.
The National Reference Center for Congenital CMV Infections at Necker Hospital, in collaboration with the virology laboratory at Paul Brousse Hospital, has developed the MyCMV "expert" tool, which is a decision-making algorithm that allows the interpretation of CMV serology and CMV PCR results.
The hypothesis of the study is that the use and provision of this MyCMV "expert" tool to health professionals (biologists, midwives and obstetricians) for the interpretation of virological results could avoid a delay in diagnosis and would allow patients to be referred more quickly to a prenatal diagnosis center for appropriate management of CMV infection.
The aim of the study is to evaluate the rate of detection of primary CMV infection in the first trimester of pregnancy using the MyCMV tool compared with the reference method (results interpreted by the centre's expert investigator). We also aim to evaluate the dating of the maternal primary infection in weeks of amenorrhoea and additional tests given by the MyCMV tool compared with the reference method.
For the study, the medical information of patients for whom CMV serology including the search for CMV IgG and IgM antibodies is prescribed in the Necker-Enfants Malades or Paul Brousse hospitals, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known, will be reinterpreted with the MyCMV tool without consequences on the care of the patients.
- Being tested
- Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed
- Keywords
- Congenital cytomegalovirus (cCMV) infection, Maternal primary cytomegalovirus infection, Maternal Screening and Diagnosis, Decision-making algorithm
- Medical subject headings
- Cytomegalovirus Infections, Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performedOther
The CMV serology results of the patients will have been previously interpreted as part of the care on the basis of the entire virological file according to the reference method.
These results will be reinterpreted using the MyCMV tool on the basis of the serology results performed (IgM, IgG, avidity), CMV PCR, the date of sampling and the date of the start of pregnancy (or last period). This reinterpretation by the tool will be carried out as part of the study and will not be communicated to the patient or to the doctor prescribing the virological analyses.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Pregnant women with prescription of a CMV serology including the search for CMV IgG and IgM antibodies, care at the Necker-Enfants Malades, Paul Brousse hospitals, or the CHU Limoges, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known. Receives: Other: Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the detection rate of primary CMV infection in the first trimester of pregnancy using the MyCMV tool
Detection of primary CMV infection in the first trimester of pregnancy by the MyCMV tool or by the reference method.
In the context of this study, the reference method is the interpretation of the results by the expert investigator of the center, without using the MyCMV tool.
Measured: Time 0
Secondary outcomes (2)
Dating in weeks of amenorrhea of the date of primary infection by the MyCMV tool and by the reference method
Dating in weeks of amenorrhea of the date of primary infection by the MyCMV tool and by the reference method.
In case of seroconversion of IgG or the presence of isolated IgM (followed by seroconversion in a subsequent serum) in the patient's previous results, evaluation of the dating in weeks of amenorrhea given by the MyCMV tool compared to the dating obtained by the reference method.
Measured: Time 0
Recommendations for the conduct to be adopted for carrying out additional analysis by the MyCMV tool
Among the cases where it is not possible to conclude as to the occurrence of a primary infection during pregnancy on the basis of the available results, identification of the course of action to be taken for carrying out the additional analysis (on a previous sample, the same sample or a new sample) proposed by the reference method and the MyCMV tool.
Measured: Time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start4 Apr 2025
- Primary completion4 Apr 2027 (estimated)
- Study completion4 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 491 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marianne Leruez-Ville, M.D., PhD, Study director, Assistance Publique - Hôpitaux de ParisJacques Fourgeaud, Pharma.D., PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694428
- Sponsor's protocol ID
- APHP240966
- Acronym
- MyCMV
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2024
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
- ClinicalTrials.gov ID
- NCT06694428
- Acronym / sponsor ID
- MyCMV / APHP240966
- Keywords
- Congenital cytomegalovirus (cCMV) infection, Maternal primary cytomegalovirus infection, Maternal Screening and Diagnosis, Decision-making algorithm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 491 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 4 Apr 2027 (estimated)
- Study completion
- 4 Apr 2027 (estimated)
- First posted
- 19 Nov 2024 (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.
Congenital cytomegalovirus (CMV) infection is the most common congenital infection with a birth prevalence of 0.4% in Europe. It is the leading non-genetic cause of sensorineural hearing loss and a major cause of neurodevelopmental disabilities. The risk of intrauterine transmission is highest when primary infection occurs during pregnancy. Primary CMV infection is asymptomatic or causes non-specific symptoms and only serology can diagnose it with certainty.
The diagnosis of CMV infection is based on the combination of 2 or 3 serological markers and the interpretation of the results is more complex than for other infections and may require additional analyses and sometimes delay the diagnosis and the implementation of secondary prevention of CMV transmission to the fetus by the administration of valaciclovir. Indeed, the effectiveness of secondary prevention is conditioned by the early administration of treatment after the maternal primary infection.
The National Reference Center for Congenital CMV Infections at Necker Hospital, in collaboration with the virology laboratory at Paul Brousse Hospital, has developed the MyCMV "expert" tool, which is a decision-making algorithm that allows the interpretation of CMV serology and CMV PCR results.
The hypothesis of the study is that the use and provision of this MyCMV "expert" tool to health professionals (biologists, midwives and obstetricians) for the interpretation of virological results could avoid a delay in diagnosis and would allow patients to be referred more quickly to a prenatal diagnosis center for appropriate management of CMV infection.
The aim of the study is to evaluate the rate of detection of primary CMV infection in the first trimester of pregnancy using the MyCMV tool compared with the reference method (results interpreted by the centre's expert investigator).
Detailed description
Congenital cytomegalovirus (CMV) infection is the most common congenital infection with a birth prevalence of 0.4% in Europe. It is the leading non-genetic cause of sensorineural hearing loss and a major cause of neurodevelopmental disabilities. The risk of intrauterine transmission is highest when primary infection occurs during pregnancy. Primary CMV infection is asymptomatic or causes non-specific symptoms and only serology can diagnose it with certainty.
The diagnosis of CMV infection is based on the combination of 2 or 3 serological markers and the interpretation of the results is more complex than for other infections and may require additional analyses and sometimes delay the diagnosis and the implementation of secondary prevention of CMV transmission to the fetus by the administration of valaciclovir. Indeed, the effectiveness of secondary prevention is conditioned by the early administration of treatment after the maternal primary infection.
The National Reference Center for Congenital CMV Infections at Necker Hospital, in collaboration with the virology laboratory at Paul Brousse Hospital, has developed the MyCMV "expert" tool, which is a decision-making algorithm that allows the interpretation of CMV serology and CMV PCR results.
The hypothesis of the study is that the use and provision of this MyCMV "expert" tool to health professionals (biologists, midwives and obstetricians) for the interpretation of virological results could avoid a delay in diagnosis and would allow patients to be referred more quickly to a prenatal diagnosis center for appropriate management of CMV infection.
The aim of the study is to evaluate the rate of detection of primary CMV infection in the first trimester of pregnancy using the MyCMV tool compared with the reference method (results interpreted by the centre's expert investigator). We also aim to evaluate the dating of the maternal primary infection in weeks of amenorrhoea and additional tests given by the MyCMV tool compared with the reference method.
For the study, the medical information of patients for whom CMV serology including the search for CMV IgG and IgM antibodies is prescribed in the Necker-Enfants Malades or Paul Brousse hospitals, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known, will be reinterpreted with the MyCMV tool without consequences on the care of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performedPregnant women with prescription of a CMV serology including the search for CMV IgG and IgM antibodies, care at the Necker-Enfants Malades, Paul Brousse hospitals, or the CHU Limoges, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with prescription of a CMV serology including the search for CMV IgG and IgM antibodies, care at the Necker-Enfants Malades or Paul Brousse hospitals or CHU Limoges, with positive CMV IgM antibodies or in the grey zone of the technique and for whom the date of start of pregnancy is known.
Key inclusion criteria (5 listed)
- Pregnant woman
- And for whom a CMV serology including the search for CMV IgG and IgM antibodies is prescribed at the Necker-Enfants Malades or Paul Brousse hospital or CHU Limoges
- And with positive anti-CMV IgM or in the grey zone of the technique
- And for whom the date of start of pregnancy is known
- And who does not object to the use of their data in the context of this research
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performedThe CMV serology results of the patients will have been previously interpreted as part of the care on the basis of the entire virological file according to the reference method. These results will be reinterpreted using the MyCMV tool on the basis of the serology results performed (IgM, IgG, avidity), CMV PCR, the date of sampling and the date of the start of pregnancy (or last period). This reinterpretation by the tool will be carried out as part of the study and will not be communicated to the patient or to the doctor prescribing the virological analyses. | Other | Patients |
Primary outcome
Evaluation of the detection rate of primary CMV infection in the first trimester of pregnancy using the MyCMV tool
Time frame: Time 0
Detection of primary CMV infection in the first trimester of pregnancy by the MyCMV tool or by the reference method. In the context of this study, the reference method is the interpretation of the results by the expert investigator of the center, without using the MyCMV tool.
2 secondary outcomes
Dating in weeks of amenorrhea of the date of primary infection by the MyCMV tool and by the reference method
Time frame: Time 0
Recommendations for the conduct to be adopted for carrying out additional analysis by the MyCMV tool
Time frame: Time 0
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 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Marianne Leruez-Ville, M.D., PhD study director
Assistance Publique - Hôpitaux de Paris
Jacques Fourgeaud, Pharma.D., PhD principal investigator
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections and Maternal Primary Cytomegalovirus Infection, run by Assistance Publique - Hôpitaux de Paris at 3 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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Jacques Dr Fourgeaud, Pharma.D., PhD (0033144495611, jacques.fourgeaud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the detection rate of primary CMV infection in the first trimester of pregnancy using the MyCMV tool (time frame: Time 0). 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 8 Jun 2026.