Fertility MonitorTRACYNCT04065464
TRACY - Track My Cycle
An observational study of Fertility Monitor and Cycle Tracking, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
Trial summary
The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fertility Monitor, Cycle Tracking
- What is being tested?
- Ava Fertility Tracker
- Type of treatment
- Medical device
- How many people
- 303 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jul 2019to 10 Jan 2020
- 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 40 years
- Women only
- Adult
Study population: All women aged 18 to 40 years matching the eligibility criteria can be enrolled in the pilot study.
Who may be able to join
- Aged between 18 and 40 at the time of admission
- Not pregnant and no pregnancy wish during the pilot study period
- Have a regular sleep pattern (sleep at least four hours per night and not working nightshift)
- Have regular menstrual cycles
Who cannot join
- Pregnant at study admission
- Currently breastfeeding or have breastfed in the past 6 months before study admission
- Currently using hormonal contraception or hormonal medication
- Health-related conditions that may affect menstrual cycle length and variability (e.g. PCOS, menopause, thyroid dysfunction)
- Unable to understand study instructions and/or not able to understand English or German
- More than one international overseas travel per month
- Unwilling to sign the ICF.
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day.
- Conditions
- Fertility Monitor, Cycle Tracking
- Being tested
- Ava Fertility Tracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ava Fertility TrackerDevice
All women aged 18 to 40 years using Ava Fertility Tracker to track their cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fine-tuning Ava algorithm
Number of days within a menstrual cycle that are correctly predicted as 'fertile' by the Ava algorithm.
Number of study participants who have their 'fertile window' accurately predicted by the Ava AG app.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start3 Jul 2019
- Primary completion20 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility MonitorStudies 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
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Epidemiology and Health Research, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Ava AG
- Responsible party
- Principal investigator, Clare Barnett, MBBS (Hons) MPH, Center for Epidemiology and Health Research, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065464
- Sponsor's protocol ID
- ZEG2019_01
- Acronym
- TRACY
- Status last verified
- Sep 2020
- First submitted
- 5 Aug 2019
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRACY - Track My Cycle
- ClinicalTrials.gov ID
- NCT04065464
- Acronym / sponsor ID
- TRACY / ZEG2019_01
- Conditions
- Fertility Monitor, Cycle Tracking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Center for Epidemiology and Health Research, GermanyUniversity, hospital or other
- Collaborators
- Ava AG
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 22 Aug 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.
The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All women aged 18 to 40 years matching the eligibility criteria can be enrolled in the pilot study.
Key inclusion criteria (4 listed)
- Aged between 18 and 40 at the time of admission
- Not pregnant and no pregnancy wish during the pilot study period
- Have a regular sleep pattern (sleep at least four hours per night and not working nightshift)
- Have regular menstrual cycles
Key exclusion criteria (7 listed)
- Pregnant at study admission
- Currently breastfeeding or have breastfed in the past 6 months before study admission
- Currently using hormonal contraception or hormonal medication
- Health-related conditions that may affect menstrual cycle length and variability (e.g. PCOS, menopause, thyroid dysfunction)
- Unable to understand study instructions and/or not able to understand English or German
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 |
|---|---|---|
| Ava Fertility TrackerAll women aged 18 to 40 years using Ava Fertility Tracker to track their cycles. | Device | – |
Primary outcome
Fine-tuning Ava algorithm
Time frame: 5 months
Number of days within a menstrual cycle that are correctly predicted as 'fertile' by the Ava algorithm. Number of study participants who have their 'fertile window' accurately predicted by the Ava AG app.
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 28 Sep 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fertility Monitor and Cycle Tracking, run by Center for Epidemiology and Health Research, Germany at 1 site in Germany.
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 4 inclusion and 7 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 28 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 Germany. 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?
Fine-tuning Ava algorithm (time frame: 5 months). 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 28 Sep 2020.