Cycle and Ovulation Study Expansion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05852951

Enrollment

698

Registered

2023-05-10

Start date

2021-06-09

Completion date

2022-05-23

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstruation

Keywords

menstruation, ovulation, menstrual cycle

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

14 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results