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To predict the fertile window and menstrual cycles with the bracelet

Prediction of the fertile window and menstrual cycles with a wearable device via machine-learning algorithms

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN54505021
Enrollment
200
Registered
2024-09-15
Start date
2021-11-20
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Prediction of fertile window and menstruation day through machine learning based on women’s physiological parameters. Not Applicable

Interventions

This is a prospective observational cohort study conducted at the Obstetrics and Gynecology Hospital of Fudan University in Shanghai, China. Participants were recruited from November 2021 to September
otherwise, the participants are considered to have irregular menstrual cycles. Participants will be followed up with at least two complete menstrual cycles. Women are required to wear the Huawei Band

Sponsors

Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Age 18~45 years old 2. Non-pregnant women 3. Have a menstrual cycle 4. Subjects with regular menstrual cycle; the duration of cycle days must be between 21 and 35 days (including 21 and 35 days); the duration of the menstrual period must not exceed 7 days; the cycle must remain regular, and the difference in days between adjacent cycles must be less than 7 days 5. Subjects with irregular menstrual cycles: do not meet the conditions of regular subjects 6. Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Suffering from major systemic diseases 2. Pregnancy history within six months 3. Breastfeeding 4. Currently taking or planning to take hormones and other medications that affect the menstrual cycle 5. Passing across time zones 6. Sleep disorders 7. Other reasons that make researchers believe the patient is not suitable to participate in this study

Design outcomes

Primary

MeasureTime frame
The sensitivity, specificity and accuracy of fertile-window prediction and menstruation prediction were measured using data collected from machine-learning algorithms based on the wrist skin temperature and heart rate after every participant completed the follow-up

Secondary

MeasureTime frame
The alteration pattern of wrist skin temperature, heart rate, heart rate variability, and respiratory rate during a menstrual cycle among regular and irregular menstruators will be measured with the Huawei Band 6 Pro at night sleep at least for five hours

Countries

China

Contacts

Public ContactHefeng ;Yanting Huang;Wu

;

fckkyk@fckyy.org.cn;yanting_wu@163.com+86 21 53513815;+86 17321218018

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026