NCT06228131

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 19, 2024

Last Update Submit

January 19, 2024

Conditions

Early Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

subjects who provided early pregnancy urine samples

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-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) .

You may qualify if:

  • Female；
  • years of age；
  • In a state of preparing for pregnancy;
  • Voluntary and sign informed consent form.

You may not qualify if:

  • Within 8 weeks of childbirth or abortion；
  • The investigator has reason to believe that it is inappropriate for subjects to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First Teaching hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

Internet Hospital of Tianjin Medical University General Hospital

Tianjin, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine sample

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 29, 2024

Study Start

August 1, 2023

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations

CN(2)