Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07469657
Eligibility Criteria:
Inclusion Criteria:
* Couple aged over 18 years
* Ongoing pregnancy of at least 7 weeks gestational age
* Requesting, within clinical care, invasive prenatal diagnosis or PCR-based NIPD for a particularly severe monogenic disorder, with indication confirmed by a Multidisciplinary Prenatal Diagnosis Center (CPDPN)
* Eligible for exclusion diagnosis
* Causative gene covered by the Agilent V8 exome capture kit
* Affiliated with the national general social security system
* Informed consent obtained from the pregnant woman and her partner
Exclusion Criteria:
* Prenatal diagnosis request not approved by a Multidisciplinary Prenatal Diagnosis Center (CPDPN)
* Disorder not analyzable by next-generation sequencing (e.g., triplet repeat expansions, sequence homology)
* Woman carrying the pathogenic variant
* Woman or partner deprived of liberty, under guardianship or curatorship
* Index case other than the father, a child, or a fetus from a previous pregnancy within the couple.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07469657
Study Brief:
Protocol Section:
NCT07469657