NCT05458778

Detection of Urinary Human Chorionic Gonadotropin (hCG)

Detection of Urinary HCG During The Not Pregnancy and Pregnancy Cycles

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Quanovate Tech Inc. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Conditions

• Pregnancy Detection

Interventions

Type	Name	Description
DEVICE	Daily test with urine by the product	Women perform the hCG test and share the test results

Timeline

• Start date: 2022-06-29
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2022-07-14
• Last updated: 2023-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study