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

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.

Study Overview

• Status: Completed
• Conditions: Ovulation Disorder
• Intervention / Treatment: Diagnostic test: Pearl Powered by Proov

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80301
      • MFB Fertility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18-45 that are activity seeking to get pregnant and want to monitor their fertility status

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pearl Powered by Proov; 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; Participants self test in their homes and report back data via uploading onto an app and taking surveys.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MFB Fertility
• Investigators: Principal Investigator: Amy Beckley, PhD, MFB Fertility

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 20, 2019
• First Posted (Actual): April 23, 2019

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017/11/7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No