Detection of Urinary Human Chorionic Gonadotropin (hCG)

Quanovate Tech

Status: Enrolling

Conditions: Pregnancy Detection

Treatments: Device: Daily test with urine by the product

Study type: Observational

Funder types: Industry

Identifiers

NCT05458778

2022/04/16

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

200 participants in 1 patient group

Women who are trying to conceive

Treatment:

Device: Daily test with urine by the product