Cycle and Ovulation Study Expansion

The objective of this study was to collect menstrual cycle, health sensor data and general health information to understand correlations between menstrual cycle and health sensor data, and how those correlations may be affected by general health. Participants entered menstrual cycle information (such as start dates, end dates, symptoms, flow), basal body temperature as measured by a thermometer, and ovulation and progesterone test results via apps installed on their iPhone. Additionally, participants were provided with an Apple Watch and a wrist-worn hardware prototype wrist-worn sleep band to collect physiological sensor data. Both menstrual cycle information and physiological sensor data stored on the participants' iPhone prior to enrolling in the study (up to 18 months) was also collected. This study aimed to collect data from females aged 14 and older who are currently menstruating with irregular and regular menstrual cycles.

Study Overview

• Status: Completed
• Conditions: Menstruation

• Study Type: Observational
• Enrollment (Actual): 698

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • Exponent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Contract research organization

Description

• At least 14 years of age (19 for residents of Alabama and Nebraska and 21 for residents of Mississippi)
• Can communicate in written and spoken English
• Own functioning iPhone iOS 14 or later, with access to reliable data plan and Wifi
• Access to reliable Wifi in the bedroom
• Willingness to participate in remote visits and follow study procedures for the duration of the study, including use of Apple Watch and a wrist-work hardware prototype
• Able to read and understand the written consent form
• Reside in the US for the duration of the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Menstrual patterns; Regular menstrual cycles and irregular menstrual cycles; irregular menstrual cycles are defined as having variation in menstrual cycles of greater than 2 days and less than 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrospective ovulation day estimate	Retrospective ovulation day estimation (algorithm uses multiple measurements including menstrual flow, urine ovulation prediction testing, basal body temperature, overnight aggregated wrist temperature)	12 months

Collaborators and Investigators

• Sponsor: Apple Inc.
• Collaborators: Exponent
• Investigators: Principal Investigator: Bo Qing, PhD, Exponent

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Actual): May 23, 2022
• Study Completion (Actual): May 23, 2022

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: menstrual cycle; ovulation; menstruation
• Other Study ID Numbers: Pro00054031

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