Menstrual Cycle Study

NCT05999123 | Completed

• 1 other identifier: GH-FH-001
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menstruation; Ovulation

Outcome Measures

Primary Outcomes (1)

• Ovulation Day Estimation

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

  6 months

Secondary Outcomes (1)

• Menstruation Day Estimation

  6 months

Study Arms (1)

All Participants

Up to 150 participants will be enrolled at one or more clinical research sites in the United States. Participants will be healthy, menstruating individuals between 18 to 42 years of age who meet all eligibility criteria.

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, menstruating individuals between 18 to 42 years of age who meet eligibility criteria from one or more clinical research sites in the United States.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fitbit LLC: lead

Study Sites (1)

Artemis Headlands LLC (Artemis Institute for Clinical Research)

San Diego, California, 92103, United States

Location

Study Officials

• Daniel Johnson, DO

  Artemis Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: July 25, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)