Fertility DisordersSUSAVANCT03161873
Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
An observational study of Fertility Disorders and Early Pregnancy, run by University of Zurich at 1 site in Switzerland.
Trial summary
In this study physiological data is measured using wearable sensors as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with regular cycles, who aim for a spontaneous pregnancy. 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 Disorders, Early Pregnancy
- What is being tested?
- Ava
- Type of treatment
- Medical device
- How many people
- 194 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2016to Nov 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In this study we want to conduct measurements of physiological data as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with a regular cycle, who aim for a spontaneous pregnancy. We choose these women to generate reliable data on changes of the measured physiological parameters in a healthy menstrual cycle, as well as to evaluate physiological changes associated with the initiation of pregnancy. We want to continue measurements in all pregnancies beginning during the study period to evaluate how the same nine physiological parameters are changing during pregnancy, how strong the variations of the parameters during pregnancy are, and whether they could be associated with early onsets of pregnancy complications such as premature birth or preeclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of one of the pregnancy complications.
Who may be able to join
- women aged 20-40 years
- regular menstrual cycle (28 days+/-)
- no hormonal therapy
- 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
- unsuccessfully trying to conceive for > 12 months
Trial locations and contacts
1 site in 1 country.
About this study
In this study physiological data is measured using wearable sensors as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with regular cycles, who aim for a spontaneous pregnancy. These women were recruited to generate reliable data on changes of the measured physiological parameters in a healthy menstrual cycle, as well as to evaluate physiological changes associated with early pregnancy.
All pregnancies beginning during the study period are to be monitored to their natural end, in order to evaluate how the same nine physiological parameters are changing during pregnancy, how strong the variations of the parameters during pregnancy are, and whether they could be associated with early onsets of pregnancy complications such as premature birth or pre-eclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of pregnancy complications.
- Conditions
- Fertility Disorders, Early Pregnancy
- Being tested
- Ava
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvaDevice
Ava is a fertility monitoring bracelet that collects various physiological parameters
| Study group | Role | What they receive |
|---|---|---|
| avaOnly | Participants will measure with Ava bracelet and determine ovulation with a home (luteinizing hormone) LH urine test Receives: Device: Ava | |
| avaSaliva | Participants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition participants will collect saliva for the measurements of estrogen and progesterone. Receives: Device: Ava | |
| avaSalivaUS | Participants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition participants will collect saliva for the measurements of estrogen and progesterone. Moreover ultrasound will be used to observe the day at which the ovum is released. Receives: Device: Ava | |
| avaBBT | Participants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition, participants will measure their basal body temperature (BBT) daily. Receives: Device: Ava |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the physiology and the menstrual cycle dynamics
Correlation between a the following physiological parameters (individually or in combination), pulse rate, respiration, skin conductance response, sleep duration and quality, and skin perfusion with the menstrual cycle dynamics
Measured: November 2016 - November 2020
Secondary outcomes (2)
Correlation between the physiology measured using a wearable device and the occurrence of pregnancy
Correlation between the following physiological parameters (individually or in combination), pulse rate, respiration, skin conductance response, sleep duration and quality, and skin perfusion with the occurrence of pregnancy.
Measured: November 2016 - November 2020
Correlation between physiology and pregnancy complications
Measured: November 2016 - November 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study startNov 2016
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Ava AG, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Responsible party
- Sponsor
- Investigators
- Brigitte Leeners, Prof, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161873
- Sponsor's protocol ID
- S_US_Ava
- Acronym
- SUSAVA
- Status last verified
- Sep 2022
- First submitted
- 9 May 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)
- ClinicalTrials.gov ID
- NCT03161873
- Acronym / sponsor ID
- SUSAVA / S_US_Ava
- Conditions
- Fertility Disorders, Early Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Ava AG, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 22 May 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.
In this study physiological data is measured using wearable sensors as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with regular cycles, who aim for a spontaneous pregnancy. These women were recruited to generate reliable data on changes of the measured physiological parameters in a healthy menstrual cycle, as well as to evaluate physiological changes associated with early pregnancy.
All pregnancies beginning during the study period are to be monitored to their natural end, in order to evaluate how the same nine physiological parameters are changing during pregnancy, how strong the variations of the parameters during pregnancy are, and whether they could be associated with early onsets of pregnancy complications such as premature birth or pre-eclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of pregnancy complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| avaOnly | – | Device: AvaParticipants will measure with Ava bracelet and determine ovulation with a home (luteinizing hormone) LH urine test |
| avaSaliva | – | Device: AvaParticipants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition participants will collect saliva for the measurements of estrogen and progesterone. |
| avaSalivaUS | – | Device: AvaParticipants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition participants will collect saliva for the measurements of estrogen and progesterone. Moreover ultrasound will be used to observe the day at which the ovum is released. |
| avaBBT | – | Device: AvaParticipants will measure with Ava bracelet and determine ovulation with a home LH urine test. In addition, participants will measure their basal body temperature (BBT) daily. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In this study we want to conduct measurements of physiological data as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with a regular cycle, who aim for a spontaneous pregnancy. We choose these women to generate reliable data on changes of the measured physiological parameters in a healthy menstrual cycle, as well as to evaluate physiological changes associated with the initiation of pregnancy. We want to continue measurements in all pregnancies beginning during the study period to evaluate how the same nine physiological parameters are changing during pregnancy, how strong the variations of the parameters during pregnancy are, and whether they could be associated with early onsets of pregnancy complications such as premature birth or preeclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of one of the pregnancy complications.
Key inclusion criteria (5 listed)
- women aged 20-40 years
- regular menstrual cycle (28 days+/-)
- no hormonal therapy
- German-speaking
- written informed consent to participate in the study
Key exclusion criteria (5 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
- unsuccessfully trying to conceive for > 12 months
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 |
|---|---|---|
| AvaAva is a fertility monitoring bracelet that collects various physiological parameters | Device | avaBBT, avaOnly, avaSaliva, avaSalivaUS |
Primary outcome
Correlation between the physiology and the menstrual cycle dynamics
Time frame: November 2016 - November 2020
Correlation between a the following physiological parameters (individually or in combination), pulse rate, respiration, skin conductance response, sleep duration and quality, and skin perfusion with the menstrual cycle dynamics
2 secondary outcomes
Correlation between the physiology measured using a wearable device and the occurrence of pregnancy
Time frame: November 2016 - November 2020
Correlation between physiology and pregnancy complications
Time frame: November 2016 - November 2020
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 2022.
- Individual participant dataSharing planned: No
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Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
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Factors Influencing Fertility or Pregnancy Health
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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.
Brigitte Leeners, Prof principal investigator
University of Zurich
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 Disorders and Early Pregnancy, run by University of Zurich at 1 site in Switzerland.
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 5 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 2022. 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 Switzerland. 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?
Correlation between the physiology and the menstrual cycle dynamics (time frame: November 2016 - November 2020). 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 2022.