Usability Study of the Pearl Fertility Tracking Device

Ovulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924453
• Other study ID #: 2017/11/7
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: MFB Fertility
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovulation Disorder

Intervention

Diagnostic Test:
• Pearl Powered by Proov
Participants self test in their homes and report back data via uploading onto an app and taking surveys.

Locations

Country	Name	City	State
United States	MFB Fertility	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
MFB Fertility

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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