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START: Sensor Technology Assessments of Reproductive Target Study

Sponsor
Ouraring Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06142097
Collaborator
UCSF Center for Reproductive Health (Other)
150
Enrollment
1
Location
21.6
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief 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. The study aimed to collect data from females with regular menstrual cycles.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sensor Technology Assessments of Reproductive Target Study
    Actual Study Start Date :
    Jun 15, 2022
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Retrospective ovulation day [6 months]

    2. Prospective ovulation day [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSF Center for Reproductive Health San Francisco California United States 94143

    Sponsors and Collaborators

    • Ouraring Inc.
    • UCSF Center for Reproductive Health

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ouraring Inc.
    ClinicalTrials.gov Identifier:
    NCT06142097
    Other Study ID Numbers:
    • OS22WH01
    First Posted:
    Nov 21, 2023
    Last Update Posted:
    Nov 21, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 21, 2023