Menstrual CycleSTARTNCT06142097
Sensor Technology Assessments of Reproductive Target Study
An observational study of Menstrual Cycle and Ovulation, run by Ouraring Inc. at 1 site in United States.
Trial summary
The objective of this study was to better understand female reproductive health in the context of using wearable technology. Participants were provided and wore an Oura Ring, tracked their menstrual cycles, provided at-home ovulation test results, and had their cycles monitored via trans-vaginal ultrasounds. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Menstrual Cycle, Ovulation, Menstruation
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 30 Sep 2024
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Convenience sampling of individuals willing to travel to clinic and who meet other criteria
Who may be able to join
- Healthy women age 18-42 years
- Regular menstrual cycles every 25-32 days
- Own an iPhone or Android mobile device
- Agree to follow study protocol such as wearing the Oura Ring for the duration of the study, at-home ovulation testing, present for frequent ultrasounds
Who cannot join
- Non-English speaking
- Current use of hormonally active medications
- History of infertility
- History of recurrent pregnancy loss
- Current circadian disruptions
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Center for Reproductive Health
San Francisco, California, 94143
About this study
The objective of this study was to better understand female reproductive health in the context of using wearable technology. Participants were provided and wore an Oura Ring, tracked their menstrual cycles, provided at-home ovulation test results, and had their cycles monitored via trans-vaginal ultrasounds. The study aimed to collect data from females with regular menstrual cycles.
- Conditions
- Menstrual Cycle, Ovulation, Menstruation
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective ovulation day
Measured: 6 months
Prospective ovulation day
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start15 Jun 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ouraring Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UCSF Center for Reproductive Health
- Responsible party
- Sponsor
- Investigators
- Eleni Jaswa, M.D., M.Sc., Principal investigator, UCSF Center for Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142097
- Sponsor's protocol ID
- OS22WH01
- Acronym
- START
- Status last verified
- Oct 2024
- First submitted
- 15 Nov 2023
- Last updated
- 15 Oct 2024
- Results posted
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensor Technology Assessments of Reproductive Target Study
- ClinicalTrials.gov ID
- NCT06142097
- Acronym / sponsor ID
- START / OS22WH01
- Conditions
- Menstrual Cycle, Ovulation, Menstruation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Ouraring Inc.Industry (pharma, biotech, devices)
- Collaborators
- UCSF Center for Reproductive Health
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 21 Nov 2023 (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 objective of this study was to better understand female reproductive health in the context of using wearable technology. Participants were provided and wore an Oura Ring, tracked their menstrual cycles, provided at-home ovulation test results, and had their cycles monitored via trans-vaginal ultrasounds. The study aimed to collect data from females with regular menstrual cycles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Convenience sampling of individuals willing to travel to clinic and who meet other criteria
Key inclusion criteria (4 listed)
- Healthy women age 18-42 years
- Regular menstrual cycles every 25-32 days
- Own an iPhone or Android mobile device
- Agree to follow study protocol such as wearing the Oura Ring for the duration of the study, at-home ovulation testing, present for frequent ultrasounds
Key exclusion criteria (5 listed)
- Non-English speaking
- Current use of hormonally active medications
- History of infertility
- History of recurrent pregnancy loss
- Current circadian disruptions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective ovulation day
Time frame: 6 months
Prospective ovulation day
Time frame: 6 months
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 15 Oct 2024.
- 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.
Eleni Jaswa, M.D., M.Sc. principal investigator
UCSF Center for Reproductive Health
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 Menstrual Cycle and Ovulation, run by Ouraring Inc. 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 4 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 15 Oct 2024. 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?
Retrospective ovulation day (time frame: 6 months). The study lists 2 primary outcomes in all. 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 15 Oct 2024.