Usability Study of the Pearl Fertility Tracking Device

MFB Fertility

Status: Completed

Conditions: Ovulation Disorder

Treatments: Diagnostic Test: Pearl Powered by Proov

Study type: Observational

Funder types: Industry

Identifiers

NCT03924453

2017/11/7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

Pearl Powered by Proov

Description:

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

Treatment:

Diagnostic Test: Pearl Powered by Proov