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Menstrual Cycle Study

Study for the Development of Biometrics-informed Menstrual Cycle Algorithms

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05999123
Enrollment
143
Registered
2023-08-21
Start date
2023-07-25
Completion date
2024-08-30
Last updated
2024-12-20

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

Conditions

Menstruation, Ovulation

Brief summary

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

Interventions

None listed

Sponsors

Fitbit LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Ovulation Day Estimation6 monthsThe algorithm's estimated ovulation day compared to the reference urinary ovulation predictor kits (OPK).

Secondary

MeasureTime frameDescription
Menstruation Day Estimation6 monthsThe algorithm's estimated menstruation date(s) compared to participants' self-reported menstruation date(s).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026