To predict the fertile window and menstrual cycles with the bracelet
| ISRCTN | ISRCTN54505021 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54505021 |
- Submission date
- 17/08/2024
- Registration date
- 15/09/2024
- Last edited
- 09/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In the field of reproductive health, many women are also using applications (apps) to track menstrual cycles and identify fertile days, during which the chance of getting pregnant is the biggest. However, the accuracy of these apps is far from satisfactory. Many parameters such as basal body temperature, cervical mucus status, and hormone levels will be input by the users themselves, and it largely increases the inconvenience. Nowadays, advances in digital health have made it possible for people to invasively monitor their health. This study aims to use the wearable device, Huawei Band 6 pro, to continuously record women’s physiological data including wrist skin temperature (WST), heart rate (HR), heart rate variability, and respiratory rate. This will aid in developing fertile window and menstruation prediction algorithms through machine learning based on women’s physiological parameters data collected by Huawei Band 6 pro. These algorithms will be applied among both regular and irregular menstruators.
Who can participate?
Healthy non-pregnant women aged 18-45 years old
What does the study involve?
In this study, there is no invasive intervention for the participants’ health. Each participant will wear the Huawei Band 6 pro to record their WST, HR, heart rate variability, and respiratory rate. These data will be recorded for at least two menstrual cycles. To determine the ovulatory day, blood tests will be done to measure the hormone levels (E2, FSH, LH, etc.) and serial ultrasonography will be done to monitor the follicular development. After these physiological data are collected, algorithms will be developed to predict the fertile window and menstrual cycle based on WST and HR among both regular and irregular menstruators.
What are the possible benefits and risks of participating?
Since sexual hormone levels will be tested and ultrasonography will be done to follow the follicle development, women enrolled in this study will have a detailed understanding of their reproductive endocrine status. There will be a low risk when participating in this study since there is no intervention.
Where is the study run from?
Obstetrics and Gynecology Hospital of Fudan University in Shanghai, China.
When is the study starting and how long is it expected to run for?
October 2021 to April 2023
Who is funding the study?
Huawei Device (Shenzhen) Co., Ltd will mainly support this study.
Who is the main contact?
1. Prof. Hefeng Huang, huanghefg@hotmail.com
2. Dr. Yanting Wu, yanting_wu@163.com
Contact information
Public, Scientific, Principal Investigator
Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, No. 419, Fangxie Rd
Shanghai
200011
China
| Phone | +86 21 53513815 |
|---|---|
| fckkyk@fckyy.org.cn |
Public, Scientific, Principal Investigator
Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, No. 419, Fangxie Rd
Shanghai
200011
China
| Phone | +86 17321218018 |
|---|---|
| yanting_wu@163.com |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Prediction of the fertile window and menstrual cycles with a wearable device via machine-learning algorithms |
| Study acronym | PreFWMC |
| Study objectives | This study aims to develop fertile window and menstruation prediction algorithms through machine learning based on women’s physiological parameters data collected by Huawei Band 6 pro for both regular and irregular menstruators. |
| Ethics approval(s) |
Approved 03/11/2021, Obstetrics and Gynecology Hospital of Fudan University Ethics Committee (No.419, Fangxie Road, Huangpu District, Shanghai, 200011, China; +86 21 53513815; fckyyllwyh@163.com), ref: 2021-195 |
| Health condition(s) or problem(s) studied | Prediction of fertile window and menstruation day through machine learning based on women’s physiological parameters. |
| Intervention | 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 2022 and followed up between December 2021 and April 2023. Women with a cycle length of 21-35 days and a period duration of no more than 7 days are regarded as being regular menstruators; 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 6 Pro at least for five hours during their every night sleep for recording parameters including wrist skin temperature (WST), heart rate (HR), heart rate variability (HRV) and respiratory rate. The day of ovulation will be determined by a senior gynecologist through follicular monitoring and serum sex hormone levels. The dataset of enrolled patients will be partitioned randomly into training and testing groups. Fertile algorithms and menstrual algorithms will be built based on WST and HR data for both regular and irregular menstruators. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Huawei Band 6 pro |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 05/10/2021 |
| Completion date | 30/04/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 229 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/11/2021 |
| Date of final enrolment | 30/09/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
200011
China
Sponsor information
Hospital/treatment centre
419 Fangxie Road, Huangpu District
Shanghai
200011
China
| Phone | +86 |
|---|---|
| not@provided.com | |
| Website | https://www.fckyy.org.cn/ |
"ROR" |
https://ror.org/04rhdtb47 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from huanghefg@hotmail.com. Data will be available immediately following publication and ending 5 years following article publication. Consent from participants was required and obtained. All data from participants will be anonymized, with all names, addresses and other personally identifiable information removed, and will be kept strictly confidential. There are no further ethical or legal restrictions. |
Editorial Notes
19/08/2024: Study's existence confirmed by the Obstetrics and Gynecology Hospital of Fudan University Ethics Committee.
