Pregnancy DetectionNCT05458778
Detection of Urinary Human Chorionic Gonadotropin (hCG)
An observational study of Pregnancy Detection, run by Quanovate Tech Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Detection
- What is being tested?
- Daily test with urine by the product
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Include more than 200 worldwide women aged 18 and over taking part in this study.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Quanovate Tech Inc.
San Ramon, California, 94583
Zheng Yang, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Daily test with urine by the product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily test with urine by the productDevice
Women perform the hCG test and share the test results
| Study group | Role | What they receive |
|---|---|---|
| Women who are trying to conceive | Not described Receives: Device: Daily test with urine by the product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive evaluation via survey and calculating the consistency
The consistency between the lay-user test results and the actual test results
Measured: 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.
Measured: From July 2022 to August 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start29 Jun 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanovate Tech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ning Li, MS, Principal investigator, Quanovate Tech Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458778
- Sponsor's protocol ID
- 2022/04/16
- Status last verified
- Apr 2023
- First submitted
- 4 Jul 2022
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Urinary HCG During The Not Pregnancy and Pregnancy Cycles
- ClinicalTrials.gov ID
- NCT05458778
- Acronym / sponsor ID
- 2022/04/16
- Conditions
- Pregnancy Detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Quanovate Tech Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women who are trying to conceive | – | Device: Daily test with urine by the product |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Include more than 200 worldwide women aged 18 and over taking part in this study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily test with urine by the productWomen perform the hCG test and share the test results | Device | Women who are trying to conceive |
Primary outcome
Cognitive evaluation via survey and calculating the consistency
Time frame: From July 2022 to August 2022
The consistency between the lay-user test results and the actual test results
The accuracy of data was expressed as per the Pregnancy Detection Rate
Time frame: From July 2022 to August 2022
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Li, MS principal investigator
Quanovate Tech Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Detection, run by Quanovate Tech Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Yang, PhD (+1 4125197085, zyang@quanovate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive evaluation via survey and calculating the consistency (time frame: From July 2022 to August 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.