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NCT04196595 Clinical Trial

Apple Women's Health Study

Infertility Clinical Trial

Official title:
Apple Women's Health Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04196595
Other study ID # Pro00037562
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 14, 2019
Est. completion date November 2029

Study information
Verified date July 2023
Source Apple Inc.
Contact Shruthi Mahalingaiah, MD
Phone 617-432-1356
Email AppleWomensHealthStudy@hsph.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational longitudinal study to advance the understanding of menstrual cycle and gynecologic health conditions including PCOS, infertility and breast cancer.The study will be hosted within the Research app(available on App Store), which allows a user to find, enroll, and participate in Apple-supported health-related research studies.

Recruitment information / eligibility
Status Recruiting
Enrollment 500000
Est. completion date November 2029
Est. primary completion date November 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have menstruated at least once - Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico) - Live in the United States of America - Be comfortable communicating in written and spoken English - Have installed the Apple Research app on your iPhone - Not share your iCloud account or iPhone with anyone else - Be willing and able to provide informed consent to participate in the study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Harvard T.H. Chan School of Public Health Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Apple Inc. Harvard School of Public Health (HSPH), National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identify Menstrual Cycle Patterns Characterized using duration of menstrual flow, and cycle length in unit of days. Up to 10 years
Primary Epidemiologic Description of Menstrual Cycle Characterized using cycle patterns and self-reported demographics, no unit of measure Up to 10 years
Secondary Determine prevalence of gynecologic health conditions Characterized using menstrual cycle patterns and self-reported health conditions, no unit of measure Up to 10 years
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