Detection of hCG in Early Pregnancy Clinical Samples

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06228131

Enrollment

241

Registered

2024-01-29

Start date

2023-08-01

Completion date

2024-01-02

Last updated

2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Pregnancy

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

China

Outcome results