Detection of hCG in Early Pregnancy Clinical Samples

January 19, 2024 updated by: Andon Health Co., Ltd
To evaluate the detection of hCG in the early pregnancy urine samples by Human chorionic gonadotropin (HCG) test system.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Tianjin, China
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
      • Tianjin, China
        • Internet Hospital of Tianjin Medical University General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

There were 241 subjects who planned to conceive but did not conceive participating in the clinical trial. Of these, 73 women successfully conceived and provided a full cycle of urine samples(10 days, from day -8 to day +1 relative to the expected period) .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
subjects who provided early pregnancy urine samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the detection of hCG in the early pregnancy urine samples by investigational device.
Time Frame: 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)
10day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andon Health Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

January 2, 2024

Study Completion (Actual)

January 2, 2024

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IHC-3000-LCFA02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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