Detection of Urinary Human Chorionic Gonadotropin (hCG)

Detection of Urinary HCG During The Not Pregnancy and Pregnancy Cycles

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05458778

Enrollment

200

Registered

2022-07-14

Start date

2022-06-29

Completion date

2023-10-31

Last updated

2023-05-01

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

Conditions

Pregnancy Detection

Brief summary

The Mira Pregnancy Test is an over-the-counter urine hCG test intended for early detection of pregnancy. The test is indicated for use four days before the expected period. Throughout this study, volunteers with non-medical backgrounds were recruited to test hCG with urine samples using the Mira Pregnancy Test during the not pregnancy cycle or pregnancy cycle. To perform the study, a total number of more than 200 volunteers will be recruited to participate in the study.

Detailed description

The studies include two parts, which are a lay user study and a urine samples test during the trying to conceive cycle. Part 1: Lay user study Part 2: Detection of hCG in Early Pregnancy Clinical Samples

Interventions

DEVICEDaily test with urine by the product

Women perform the hCG test and share the test results

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Female * Aged 18 and over * Willing to give informed consent * Willing to conduct a personal home pregnancy test and reveal their pregnancy status * Have a working smartphone

Exclusion criteria

* Have a medical background or have been in a related industry/occupation * Volunteers who are unfit to participate in the research by the researcher * Used the investigational pregnancy test previously * Has a medical condition * Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)

Design outcomes

Primary

Measure	Time frame	Description
Cognitive evaluation via survey and calculating the consistency	From July 2022 to August 2022	The consistency between the lay-user test results and the actual test results
The accuracy of data was expressed as per the Pregnancy Detection Rate	From July 2022 to August 2022	The number of positive results on different days obtained by the user of the Mira pregnancy test is divided by the total number of women who confirmed pregnancy.

Countries

United States

Contacts

Primary ContactZheng Yang, PhD

zyang@quanovate.com+1 4125197085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026