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Recruiting NCT04196595

Apple Women's Health Study

Observational Menstrual Cycle Ovulation Menstruation Polycystic Ovary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Menstrual Cycle, Ovulation, Menstruation, Polycystic Ovary Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Identify Menstrual Cycle Patterns [Time frame: Up to 10 years]
  • Epidemiologic Description of Menstrual Cycle [Time frame: Up to 10 years]
Secondary outcome measures (1)
  • Determine prevalence of gynecologic health conditions [Time frame: Up to 10 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Harvard T.H. Chan School of Public Health — Boston

Publications

  • Zhang CY, Li H, Zhang S, Suharwardy S, Chaturvedi U, Fischer-Colbrie T, Maratta LA, Onnela JP, Coull BA, Hauser R, Williams MA, Baird DD, Jukic AMZ, Mahalingaiah S, Curry CL. Abnormal uterine bleeding patterns determined through menstrual tracking among participants in the Apple Women's Health Study. Am J Obstet Gynecol. 2023 Feb;228(2):213.e1-213.e22. doi: 10.1016/j.ajog.2022.10.029. Epub 2022 Oc PMID 36414993

Identifiers

NCT: NCT04196595 · Pro00037562

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗