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OpenTrials
Completed

NCT Number: NCT05852951

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.

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Key information

Conditions

Menstruation

Age range

14 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Exponent

Phoenix, Arizona, 85027, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. Retrospective ovulation day estimate

    Time frame: 12 months

    Retrospective ovulation day estimation (algorithm uses multiple measurements including menstrual flow, urine ovulation prediction testing, basal body temperature, overnight aggregated wrist temperature)

Sponsors and collaborators

Lead sponsor

Apple Inc.

Industry

Collaborators

  • Exponent

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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