FertilityPDMCNCT03128983
Physiological Data in the Menstrual Cycle
An observational study of Fertility, run by Ava AG.
Trial summary
Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 31 Dec 2016
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A maximum of 50 healthy, 20-40 years old, non-pregnant women will be included in the study.
Who may be able to join
- Healthy, non-pregnant women aged 20-40 years (healthy volunteers)
- Regular cycling (28 days +/- 2)
- Non-hormonal contraception methods used
- German-speaking
- Written informed consent to participate in the study
Who cannot join
- Any health-related issues that may affect menstrual cycle
- Any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
- Frequent travel between time zones
- Sleeping disorders
About this study
Official title: Variations of Physiological Data Throughout the Menstrual Cycle
Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. The present study aims to evaluate whether there is a correlation between physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine ovulation test and the onset of menses. To collect data women will wear two smartwatches and a smartshirt at night. All three devices are CE-approved for sports and fitness.
- Conditions
- Fertility
- Being tested
- Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between menstrual cycle dynamics and physiology
Correlation between a combination of the physiological parameters heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion and menstrual cycle dynamics.
Measured: During 1 menstrual cycle between 24 days and 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Feb 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ava AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Zürich, Centre Suisse d'Electronique et de Microtechnique (CSEM), Switzerland, Empa, Swiss Federal Laboratories for Materials Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128983
- Sponsor's protocol ID
- Emilia
- Acronym
- PDMC
- Status last verified
- Nov 2018
- First submitted
- 21 Apr 2017
- Last updated
- 7 Nov 2018
- 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 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations of Physiological Data Throughout the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT03128983
- Acronym / sponsor ID
- PDMC / Emilia
- Conditions
- Fertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ava AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Zürich, Centre Suisse d'Electronique et de Microtechnique (CSEM), Switzerland, Empa, Swiss Federal Laboratories for Materials Science and Technology
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 25 Apr 2017 (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.
Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. The present study aims to evaluate whether there is a correlation between physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine ovulation test and the onset of menses. To collect data women will wear two smartwatches and a smartshirt at night. All three devices are CE-approved for sports and fitness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A maximum of 50 healthy, 20-40 years old, non-pregnant women will be included in the study.
Key inclusion criteria (5 listed)
- Healthy, non-pregnant women aged 20-40 years (healthy volunteers)
- Regular cycling (28 days +/- 2)
- Non-hormonal contraception methods used
- German-speaking
- Written informed consent to participate in the study
Key exclusion criteria (4 listed)
- Any health-related issues that may affect menstrual cycle
- Any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
- Frequent travel between time zones
- Sleeping disorders
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 |
|---|---|---|
| Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation | Device | – |
Primary outcome
Correlation between menstrual cycle dynamics and physiology
Time frame: During 1 menstrual cycle between 24 days and 35 days
Correlation between a combination of the physiological parameters heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion and menstrual cycle dynamics.
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 7 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility, run by Ava AG.
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 5 inclusion and 4 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between menstrual cycle dynamics and physiology (time frame: During 1 menstrual cycle between 24 days and 35 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 7 Nov 2018.