Ovulation DisorderNCT03924453
Usability Study of the Pearl Fertility Tracking Device
An observational study of Ovulation Disorder, run by MFB Fertility at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovulation Disorder
- What is being tested?
- Pearl Powered by Proov
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: Women aged 18-45 that are activity seeking to get pregnant and want to monitor their fertility status
Who may be able to join
- 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)
Who cannot join
- Male
- Pregnant
- Nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovulation Disorder
- Being tested
- Pearl Powered by Proov
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pearl Powered by ProovDiagnostic test
Participants self test in their homes and report back data via uploading onto an app and taking surveys.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Pearl Powered by Proov |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A single menstrual cycle, up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Dec 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- MFB Fertility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Beckley, PhD, Principal investigator, MFB Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924453
- Sponsor's protocol ID
- 2017/11/7
- Status last verified
- Sep 2020
- First submitted
- 17 Apr 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Effectiveness of a Digitally Integrated Ovulation Prediction Kits for Fertility Tracking - Pearl Powered by Proov
- ClinicalTrials.gov ID
- NCT03924453
- Acronym / sponsor ID
- 2017/11/7
- Conditions
- Ovulation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- MFB FertilityIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pearl Powered by Proov | – | Diagnostic Test: Pearl Powered by ProovParticipants 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women aged 18-45 that are activity seeking to get pregnant and want to monitor their fertility status
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- Male
- Pregnant
- Nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pearl Powered by ProovParticipants self test in their homes and report back data via uploading onto an app and taking surveys. | Diagnostic test | Pearl Powered by Proov |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Ovulation Disorder
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Recruiting
LE + CC vs. LE for Ovulation Induction
Letrozole, Clomiphene Citrate
Recruiting
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders
ICSI, IVF
Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Beckley, PhD principal investigator
MFB Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovulation Disorder, run by MFB Fertility at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with positive PDG test results (time frame: A single menstrual cycle, up to 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.