Usability Study of the Pearl Fertility Tracking Device

Study Overview
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Brief Summary
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This mobile application measures the level of certain hormones in the urine of a woman and is used to help pinpoint when the woman is/was most likely to get pregnant during her menstrual cycle.

Detailed Description
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The purpose of the study is to evaluate the accuracy of ovulation monitoring using hormone test strips in a digital way via a mobile application. Ovulation prediction kits consist of test strips that measure three different hormones - LH (luteinizing hormone), FSH (follicle stimulating hormone), PdG (pregnanediol). Through daily testing with the mobile application, it is possible to measure these hormones and build hormonal profiles along the menstrual cycle. This way we can accurately predict and confirm ovulation, as well as calculate the most fertile days in the cycle. There are multiple solutions that claim to accurately monitor fertility. However, some of these solutions use period statistics with high level of error, for example period trackers, or body temperature monitors. Some others use hormonal test strips in which reading/interpretation is not always easy. This study evaluates the accuracy of using hormone test strips in combination with an app that will digitally read and record data over time.

Official Title
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Use and Effectiveness of a Digitally Integrated Ovulation Prediction Kits for Fertility Tracking - Pearl Powered by Proov

Conditions
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Ovulation Disorder

Intervention / Treatment
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* Diagnostic Test: Pearl Powered by Proov


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female (mandatory) Not currently pregnant or nursing (mandatory) Aged 21-45 (advanced age can hinder hormone levels) Not be diagnosed as sub fertile (infertility causes inconsistent hormone levels) Not have used any form of hormonal birth control in the past 2 months (mandatory) Currently trying to conceive (ideal but not required) Currently reside in the US (mandatory, this study is for US residents only) Exclusion Criteria: Male Pregnant Nursing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pearl Powered by Proov<br>Participants are given hormone tests strips and a digital app and all instructions for use, collectively called the Pearl Power by Proov kit. The app will analyze hormonal test strip information to predict and confirm ovulation | Diagnostic Test: Pearl Powered by Proov<br>* Participants self test in their homes and report back data via uploading onto an app and taking surveys.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with positive PDG test results | phone application will be used to record LH, FSH, and PDG tests. Number of participants with positive PDG test strips will be reported. | A single menstrual cycle, up to 45 days |