Use and Effectiveness of a Digitally Integrated Ovulation Prediction Kits for Fertility Tracking - Pearl Powered by Proov
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Number of Participants with positive PDG test results
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported