Detection of Urinary Human Chorionic Gonadotropin (hCG)
Detection of Urinary HCG During The Not Pregnancy and Pregnancy Cycles
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2022
CompletedFirst Submitted
Initial submission to the registry
July 4, 2022
CompletedFirst Posted
Study publicly available on registry
July 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedMay 1, 2023
April 1, 2023
1.3 years
July 4, 2022
April 27, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Women who are trying to conceive
Interventions
Women perform the hCG test and share the test results
Eligibility Criteria
Include more than 200 worldwide women aged 18 and over taking part in this study.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quanovate Tech Inc.
San Ramon, California, 94583, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ning Li, MS
Quanovate Tech Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2022
First Posted
July 14, 2022
Study Start
June 29, 2022
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
May 1, 2023
Record last verified: 2023-04