NCT06142097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2.3 years

First QC Date

November 15, 2023

Last Update Submit

October 10, 2024

Conditions

Menstrual CycleOvulationMenstruation

Outcome Measures

Primary Outcomes (2)

  • Retrospective ovulation day

    6 months

  • Prospective ovulation day

    6 months

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Center for Reproductive Health

San Francisco, California, 94143, United States

Location

Study Officials

  • Eleni Jaswa, M.D., M.Sc.

    UCSF Center for Reproductive Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

June 15, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)