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NCT06694428: MyCMV
Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals
trial testing Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed in Cytomegalovirus Infections in 491 participants. Currently enrolling.
4 April 2026
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 491 |
| Start date | 4 April 2025 |
| Primary completion | 4 April 2026 |
| Estimated completion | 4 April 2026 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Reinterpretation of CMV serology results using the MyCMV tool on the basis of the serology results performed
Conditions studied
- Cytomegalovirus Infections — all drugs for Cytomegalovirus Infections →
- Maternal Primary Cytomegalovirus Infection — all drugs for Maternal Primary Cytomegalovirus Infection →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, female only, with Cytomegalovirus Infections or Maternal Primary Cytomegalovirus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06694428
- Europe PMC full search
- ASCO Meeting Library
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Related trials
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- NCT06554197 — Evaluation of CMV/EBV-CMI in Haploid HSCT · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06694428 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 12 September 2025
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