Detection of Urinary Human Chorionic Gonadotropin (hCG)

Detection of Urinary HCG During The Not Pregnancy and Pregnancy Cycles

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Detection
• Intervention / Treatment: Device: Daily test with urine by the product

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Zheng Yang, PhD; Phone Number: +1 4125197085; Email: zyang@quanovate.com

Study Locations

• United States
  • California
    • San Ramon, California, United States, 94583
      • Recruiting
      • Quanovate Tech Inc.
      • Contact: Zheng Yang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Include more than 200 worldwide women aged 18 and over taking part in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women who are trying to conceive	Device: Daily test with urine by the product; Women perform the hCG test and share the test results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive evaluation via survey and calculating the consistency	The consistency between the lay-user test results and the actual test results	From July 2022 to August 2022
The accuracy of data was expressed as per the Pregnancy Detection Rate	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.	From July 2022 to August 2022

Collaborators and Investigators

• Sponsor: Quanovate Tech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022/04/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes