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Usability Study of the Pearl Fertility Tracking Device

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03924453
Enrollment
35
Registered
2019-04-23
Start date
2017-12-01
Completion date
2019-12-31
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovulation Disorder

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTPearl Powered by Proov

Participants self test in their homes and report back data via uploading onto an app and taking surveys.

Sponsors

MFB Fertility
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

Inclusion criteria

1. Female (mandatory) 2. Not currently pregnant or nursing (mandatory) 3. Aged 21-45 (advanced age can hinder hormone levels) 4. Not be diagnosed as sub fertile (infertility causes inconsistent hormone levels) 5. Not have used any form of hormonal birth control in the past 2 months (mandatory) 6. Currently trying to conceive (ideal but not required) 7. Currently reside in the US (mandatory, this study is for US residents only)

Exclusion criteria

1. Male 2. Pregnant 3. Nursing

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with positive PDG test resultsA single menstrual cycle, up to 45 daysphone application will be used to record LH, FSH, and PDG tests. Number of participants with positive PDG test strips will be reported.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026