Detection of Urinary Human Chorionic Gonadotropin (hCG)

Recruiting

• Conditions: Pregnancy Detection
• Interventions: Device: Daily test with urine by the product

• Registration Number: NCT05458778
• Lead Sponsor: Quanovate Tech Inc.

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

Study Timeline

• Study Start: 2022-06-29
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women who are trying to conceive	Daily test with urine by the product	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Quanovate Tech Inc.; 🇺🇸 San Ramon, California, United States