New home pregnancy test put to the test: will it be easy and accurate?
NCT ID NCT07304531
First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study is checking if a new over-the-counter pregnancy test, called First To Know, works well when people use it at home. About 1705 women of different ages will take the test themselves and compare results to a standard blood test. The goal is to see if the test is accurate and simple enough for anyone to use without help.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- First To Know Pregnancy Test (a urine-based diagnostic device)
- What this could lead to
- If successful, this could lead to a reliable over-the-counter pregnancy test that people can use at home with confidence.
- What could go wrong
- This is an observational study evaluating an already FDA-cleared test for OTC use. The main risk is that real-world users may not use it as accurately as trained staff, which could affect performance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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892 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Female residents of the United States who elect to participate in the study.
- Ages
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14 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Females whose pregnancy status is unknown (e.g., have not used urine test at home) * Not menstruating at the time of the initial study visit * Must be willing to complete all study activities, provide all specimens/samples, and conduct all required testing * Willing to provide information regarding the diagnosis of pregnancy or details from their standard of care follow-up visit after initial visit * Sexually active * Not using contraceptives * English/Spanish speaking Exclusion Criteria: * Males * Females \<14 years of age * People with limited or no reading skills
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ERA Health Research
Midland, Texas, 79707, United States
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Matrix Clinical Research Los Angeles
Los Angeles, California, 90057, United States