Cycle and Ovulation Study Expansion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

698 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-09

Study Completion Date

2022-05-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Menstruation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No