Detection of Urinary Human Chorionic Gonadotropin (hCG)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-29

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Pregnancy Detection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women who are trying to conceive

Daily test with urine by the product

Intervention Type DEVICE

Women perform the hCG test and share the test results

Interventions

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Daily test with urine by the product

Women perform the hCG test and share the test results

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes