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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Menopause
• Menstrual Cycle
• Menstruation
• Ovulation
• Polycystic Ovary Syndrome
• Reproduction
• Reproductive Health

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