Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
NCT ID: NCT06228118
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
502 participants
OBSERVATIONAL
2023-08-04
2023-09-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Subjects enrolled in method comparison study only
No interventions assigned to this group
Subjects enrolled in both the method comparison study and lay user study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 18-55 years of age；
* Voluntary and sign informed consent form.
* 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.
18 Years
55 Years
FEMALE
Yes
Sponsors
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Andon Health Co., Ltd
INDUSTRY
Responsible Party
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Locations
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First Teaching hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, , China
Countries
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Other Identifiers
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IHC-3000-LCFA01
Identifier Type: -
Identifier Source: org_study_id
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