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Ovulation Double Check (Proov) Verification and Usability Testing

NCT03924440 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-03-19

No results posted yet for this study

Summary

The Ovulation Double Check test is a Class I, 510K exempt medical device. It is manufactured and packaged in an FDA-registered and cGMP compliant facility. This device measures the level of Pregnanediol (PdG), the major urine metabolite of progesterone, in the urine of women. PdG has been shown to increase significantly after ovulation has occurred. This test will be used in a home setting as a point-of-care device, providing couples additional information about menstrual cycling and possible fertile periods. The investigators have successfully developed prototype devices that can accurately measure PdG in urine. Now the investigators need to supply these prototype devices to end users to verify the assay is working correctly and determine if the device was designed properly in order for home users to 1) use the test properly, 2) read the test results properly, and 3) interpret the results correctly.

Conditions

  • Ovulation Disorder

Interventions

DIAGNOSTIC_TEST

Proov (Ovulation Double Check) Test

Rapid response urine progesterone test strips, Proov (formerly named Ovulation Double Check

Sponsors & Collaborators

  • MFB Fertility

    lead INDUSTRY

Principal Investigators

  • Amy Beckley, PhD · MFB Fertility

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2021-12-31
Completion
2022-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03924440 on ClinicalTrials.gov