Sensor Technology Assessments of Reproductive Target Study | NCT06142097

Studies
Sensor Technology Assessments of Reproductive Target Study

NCT06142097

Sponsor

Ouraring Inc.

Status

Completed

Last Update Posted

Oct 15, 2024Actual

Enrollment

119Actual

Phase

Not provided

Conditions

Menstrual Cycle
Ovulation
Menstruation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2022Actual

Primary Completion Date

Sep 30, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Nov 15, 2023

First Posted Date

Nov 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2024

Last Update Posted Date

Oct 15, 2024Actual

Name	Class
UCSF Center for Reproductive Health	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

119Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective ovulation day		6 months
Prospective ovulation day		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eleni Jaswa, M.D., M.Sc.	UCSF Center for Reproductive Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Center for Reproductive Health		San Francisco	California	94143	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided