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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06228131
Other study ID # IHC-3000-LCFA02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date January 2, 2024

Study information

Verified date January 2024
Source Andon Health Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system.


Recruitment information / eligibility

Status Completed
Enrollment 241
Est. completion date January 2, 2024
Est. primary completion date January 2, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Female; - 18-55 years of age; - In a state of preparing for pregnancy; - Voluntary and sign informed consent form. Exclusion Criteria: - Within 8 weeks of childbirth or abortion; - The investigator has reason to believe that it is inappropriate for subjects to participate in the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China First Teaching hospital of Tianjin University of Traditional Chinese Medicine Tianjin
China Internet Hospital of Tianjin Medical University General Hospital Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Andon Health Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the detection of hCG in the early pregnancy urine samples by investigational device. Percentage Pregnancy Results (%) for early pregnancy urine samples on different days from day -8 to day +1 relative to the expected period.
Percentage Pregnancy Results (%): 79% (day -5 relative to the expected period)
10day
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