Detection of hCG in Early Pregnancy Clinical Samples

Completed

• Conditions: Early Pregnancy

• Registration Number: NCT06228131
• Lead Sponsor: Andon Health Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 241

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the detection of hCG in the early pregnancy urine samples by investigational device.	10day	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)

Trial Locations

Locations (2)

First Teaching hospital of Tianjin University of Traditional Chinese Medicine; 🇨🇳 Tianjin, China

Internet Hospital of Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China