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OpenTrials
Completed

NCT Number: NCT05999123

Menstrual Cycle Study

A data collection study to develop algorithms to estimate menstrual cycle phases.

Completed

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Key information

Conditions

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Artemis Headlands LLC (Artemis Institute for Clinical Research)

San Diego, California, 92103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Adults who are between 18 - 42 years old at enrollment and menstruate
  • Capable of giving informed consent in Spanish or English
  • Menstrual cycle lengths between 21- 45 days
  • Have tracked menstruation for at least 3 menstrual cycles out of the prior 6 months
  • Willing to wear a wrist-worn wearable device continuously for 6 months
  • Willing to use an ovulation predictor kit for 6 months
  • Willing to report vaccine history
  • Owns a smartphone compatible with the study and has access to wi-fi

Exclusion:

  • A citizen of the European Union or United Kingdom
  • Trying to conceive during the six-month study period
  • Have used specific forms of birth control in the 3 months prior to the study or planning on using specific birth control methods during the study duration
  • Participant has undergone hormonal treatment in the past 3 months or planning to do so during the study
  • Known history of health-related issues that affect their menstrual cycle, history of pelvic radiation, vasomotor symptoms, endometriosis, fibroids, polyps, ovarian cysts or known history of health-related issues that affect the physiology
  • Currently (or within the past 3 months) engaged in health impacting behaviors
  • Have been breastfeeding or pregnant in the past 6 months prior to the study
  • On medications or taking substances that could affect their menstrual cycle or physiology
  • Travel frequently such as crossing more than two time zones at least once every 2 weeks
  • Have a known sleeping disorder or consistently work night shifts

Treatment and study plan

Primary outcomes

  1. Ovulation Day Estimation

    Time frame: 6 months

    The algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).

Secondary outcomes

  1. Menstruation Day Estimation

    Time frame: 6 months

    The algorithm's estimated menstruation date(s) compared to participants' self-reported menstruation date(s).

Sponsors and collaborators

Lead sponsor

Fitbit LLC

Industry

Registry information

Official study title

Study for the Development of Biometrics-informed Menstrual Cycle Algorithms

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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