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:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT04157595
Eligibility Criteria:
In order to take part in the study, couples need to have visited a recruiting HCP who will assess them for eligibility based on the criteria below:
INCLUSION CRITERIA
* Planning to become pregnant or in early pregnancy (less than 10 weeks gestation at enrolment and less than 11 weeks gestation at sample receipt by the laboratory)
* Both members of the couple available to participate in the study and available to provide a sample for testing at the same time.
* If the couples are using an egg/sperm donor/s, the donor/s need to be available to provide a DNA sample for testing and consent to having carrier screening.
NB: If both members of the couple are known carriers of the same autosomal recessive condition, or the female is a known carrier of an X-linked recessive condition, they will still be eligible to have RGCS through the study, but will only be considered an 'increased-risk' couple for the purposes of this study if they are identified through the study testing to be carriers of pathogenic variants in a different gene.
EXCLUSION CRITERIA
Participating couples meeting any of the following requirements will be excluded from this study:
* Pregnant and greater than 10 weeks gestation at enrolment.
* Only one member of the couple agrees to participate in the study.
* One or both members of the couple are less than 18 years old.
* Both members of the couple are not available to be tested at the same time.
* The couple are using an egg/sperm donor/s and the donor/s are not available for testing or the couple are using an anonymous donor.
* One member of the couple has already been screened as part of the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04157595
Study Brief:
Protocol Section:
NCT04157595