Sensor Technology Assessments of Reproductive Target Study (START)

November 15, 2023 updated by: Ouraring Inc.
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Center for Reproductive Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Convenience sampling of individuals willing to travel to clinic and who meet other criteria

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-English speaking
  • Current use of hormonally active medications
  • History of infertility
  • History of recurrent pregnancy loss
  • Current circadian disruptions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retrospective ovulation day
Time Frame: 6 months
6 months
Prospective ovulation day
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ouraring Inc.

Collaborators

UCSF Center for Reproductive Health

Investigators

  • Principal Investigator: Eleni Jaswa, M.D., M.Sc., UCSF Center for Reproductive Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • OS22WH01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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