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OpenTrials
Completed

NCT Number: NCT03924453

Usability Study of the Pearl Fertility Tracking Device

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

MFB Fertility

Boulder, Colorado, 80301, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pearl Powered by Proov

Diagnostic Test

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

Primary outcomes

  1. Number of Participants with positive PDG test results

    Time frame: A single menstrual cycle, up to 45 days

    phone application will be used to record LH, FSH, and PDG tests. Number of participants with positive PDG test strips will be reported.

Sponsors and collaborators

Lead sponsor

MFB Fertility

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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