Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System

Launched by ANDON HEALTH CO., LTD · Jan 19, 2024

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

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.