Detection of Urinary Human Chorionic Gonadotropin (hCG)

Last updated: April 27, 2023
Sponsor: Quanovate Tech Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Daily test with urine by the product

Clinical Study ID

NCT05458778
2022/04/16
  • Ages 18-80
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Daily test with urine by the product
Phase:
Study Start date:
June 29, 2022
Estimated Completion Date:
October 31, 2023

Study 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

Connect with a study center

  • Quanovate Tech Inc.

    San Ramon, California 94583
    United States

    Active - Recruiting

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