Cycle and Ovulation Study Expansion

NCT05852951 | Completed

• 1 other identifier: Pro00054031
• Study Type: observational
• Target: 698
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menstruation

Keywords

menstruation; ovulation; menstrual cycle

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Contract research organization

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Apple Inc.: lead
• Exponent: collaborator

Study Sites (1)

Exponent

Phoenix, Arizona, 85027, United States

Location

Related Publications (1)

• Wang Y, Park J, Zhang CY, Jukic AMZ, Baird DD, Coull BA, Hauser R, Mahalingaiah S, Zhang S, Curry CL. Performance of algorithms using wrist temperature for retrospective ovulation day estimate and next menses start day prediction: a prospective cohort study. Hum Reprod. 2025 Mar 1;40(3):469-478. doi: 10.1093/humrep/deaf005.

  PMID: 39881571 DERIVED

Study Officials

• Bo Qing, PhD

  Exponent

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: May 10, 2023
• Study Start: June 9, 2021
• Primary Completion: May 23, 2022
• Study Completion: May 23, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)