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:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT06228118
Eligibility Criteria:
Inclusion Criteria:
1. Method comparison study exclusion criteria
* Female；
* 18-55 years of age；
* Voluntary and sign informed consent form.
2. Lay user study inclusion criteria
* Female；
* 18-55 years of age；
* Voluntary and sign informed consent form；
* Willingness to perform self-test of investigational device；
* Have the ability to read English.
Exclusion Criteria:
1. Method comparison study exclusion criteria
* Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
* Within 8 weeks of childbirth or abortion；
* The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
2. Lay user study inclusion criteria
* Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
* Within 8 weeks of childbirth or abortion；
* The investigator has reason to believe that it is inappropriate for subjects to participate in the study；
* Background in a medical or laboratory testing.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06228118
Study Brief:
Protocol Section:
NCT06228118