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

Andon Health

Status: Completed

Conditions: Early Pregnancy

Study type: Observational

Funder types: Industry

Identifiers

NCT06228118

IHC-3000-LCFA01

Details and patient eligibility

About

This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.

Lay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.

Enrollment: 502 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

502 participants in 2 patient groups

Subjects enrolled in method comparison study only

Subjects enrolled in both the method comparison study and lay user study