NCT03924453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

April 17, 2019

Last Update Submit

September 2, 2020

Conditions

Ovulation Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

Pearl Powered by ProovDIAGNOSTIC_TEST

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

Pearl Powered by Proov

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only due to ovulation tracking diagnostic
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • Male
  • Pregnant
  • Nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MFB Fertility

Boulder, Colorado, 80301, United States

Location

Study Officials

  • Amy Beckley, PhD

    MFB Fertility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 23, 2019

Study Start

December 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)