Detection of hCG in Early Pregnancy Clinical Samples

Early Pregnancy Clinical Trial

Official title:

Detection of hCG in Early Pregnancy Clinical Samples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06228131
• Other study ID #: IHC-3000-LCFA02
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Early Pregnancy

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