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NCT Number: NCT06523543

Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells

Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Montpellier

Montpellier, France, 34295

Location status: Recruiting

Location contact

Vincent GATINOIS, Dr

PRINCIPAL_INVESTIGATOR

About this study

During pregnancy, biological screening for genetic diseases of the fetus cannot be implemented before the 11th week of amenorrhea whatever the technique used. This delay is long and distressing, particularly for people at high risk of transmission of genetic diseases. The presence of extravillous trophoblast cells to the cervix of the pregnant woman from the 7th week, accessible by a cervicovaginal smear non-invasive, represents new biological material representative of the fetal genome. This project aimed at evaluating the performance of a method for analyzing these trophoblast cells extra-villous at the start of pregnancy. The investigators want to evaluate performance analytical aspects of this method, that is to say, verifying that the genetic information resulting from these cells correspond to those of the fetus.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant woman
  • Singleton pregnancy
  • Pregnancy between 7 and 16 weeks of amenorrhea (WA)
  • Woman ≥ 18 years
  • Woman who has signed an informed consent
  • Woman affiliated to social security or equivalent scheme

Exclusions Criteria:

  • Person under guardianship or curatorship
  • Person placed under legal protection
  • Person unable to provide the participant with informed consent.

Treatment and study plan

Inclusion (Visit 1 - Week 7-16)

Procedure

Extraction of cervico-vaginal sampling

Second semester of pregnancy (Visit 2 - Week 20-24)

Diagnostic Test

Ultrasound examination (determination of chromosomal sex)

Third semester of pregnancy (Visit 3- Week 34)

Diagnostic Test

Ultrasound examination (determination of chromosomal sex) if this has not be done during the Visit 2 or if a new determination correcting the previous one is provided.

Primary outcomes

  1. Establish an ultra-early detection method

    Time frame: Visit 2 (Week 20-24)

    Collect fetal phenotypic data obtained during the second or the 3rd trimester via ultrasound echography

Secondary outcomes

  1. Evaluate the ability of the method to provide a result in the context of a progressive pregnancy

    Time frame: Visit 2 (Week 20-24)

    • Time (minutes) elapsed between sampling and biological validation of the result
    • Number of trophoblast cells identified
    • Failure rate: number of samples for which biological signals were not successful to determine the fetal chromosomal sex
  2. Expected benefit of ultra-early cytogenetic information

    Time frame: Visit 2 (Week 20-24)

    Evaluate the ability of the method to provide a rapid result and evaluate the impact of information about pregnant women

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent GATINOIS, MD

CONTACT

[email protected]

0 67 33 68 66

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: CellF-Cervix

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 26, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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