OvulationNCT04382001
Heart Rate Variability During the Menstrual Cycle
An observational study of Ovulation, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
In this study, women will be required to wear a chest heart rate monitor and wrist heart rate monitor daily and collect daily early morning urine samples for the duration of one complete menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovulation
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 6 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Aged 18 years of age and over
- Regular menstrual cycles (23-35 days in length)-
Who cannot join
- Taking any hormonal medications
- Taking any medications that may affect heart rate
- Known heart condition or use of a pacemaker
- Skin condition where there is sensitivity to wearing a skin monitor
- Currently suffering with anxiety or panic attacks
- Pregnant or breastfeeding
- Undertaking any frequent travel or long-haul flights during the course of the study
- Does not have access to an Apple iPhone or iPad with Bluetooth 4.0 (or later) and iOS 10.0 (or later)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
About this study
Official title: Further Investigations of Heart Rate Variability During the Menstrual Cycle
In this study, women will be required to wear a chest heart rate monitor and wrist heart rate monitor daily and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.
Read the detailed description
This study is a prospective observational study of women's heart rate and heart rate variability throughout one complete menstrual cycle. A minimum of 10 volunteers aged 18 years of age or over will be recruited via a variety of methods according to the criteria detailed in section 9. They will be required to wear a chest heart rate monitor and wrist heart rate monitor for 1 hour each day, and throughout the night for one menstrual cycle. In addition, a daily early morning urine sample will be collected throughout the study.
Urine samples will be returned to SPD on a regular basis for measurement of urinary hormones related to pregnancy and fertility. Data collected via the monitors including heart rate and heart rate variability will be downloaded for comparison.
- Conditions
- Ovulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate at time points throughout the menstrual cycle
Measured: 1 month
Heart Rate
Heart rate variability at time points throughout the menstrual cycle
Measured: 1 month
Day of Ovulation
Day of ovulation determined by urinary LH surge +1 day
Measured: 1 month
Fertile Window
Fertile window onset determined by E3G surge
Measured: 1 month
Fertile window
Fertile window closure determined by P3G rise
Measured: 1 month
Secondary outcomes (1)
Comparisons between wrist and chest band monitors
Agreement between wrist band and chest band heart rate data
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Jun 2020
- Primary completion6 May 2021
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OvulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Study director, SPD Development Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382001
- Sponsor's protocol ID
- PROTOCOL-1196
- Status last verified
- Aug 2021
- First submitted
- 6 May 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Further Investigations of Heart Rate Variability During the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT04382001
- Acronym / sponsor ID
- PROTOCOL-1196
- Conditions
- Ovulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, women will be required to wear a chest heart rate monitor and wrist heart rate monitor daily and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.
Detailed description
This study is a prospective observational study of women's heart rate and heart rate variability throughout one complete menstrual cycle. A minimum of 10 volunteers aged 18 years of age or over will be recruited via a variety of methods according to the criteria detailed in section 9. They will be required to wear a chest heart rate monitor and wrist heart rate monitor for 1 hour each day, and throughout the night for one menstrual cycle. In addition, a daily early morning urine sample will be collected throughout the study.
Urine samples will be returned to SPD on a regular basis for measurement of urinary hormones related to pregnancy and fertility. Data collected via the monitors including heart rate and heart rate variability will be downloaded for comparison.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Aged 18 years of age and over
- Regular menstrual cycles (23-35 days in length)-
Key exclusion criteria (8 listed)
- Taking any hormonal medications
- Taking any medications that may affect heart rate
- Known heart condition or use of a pacemaker
- Skin condition where there is sensitivity to wearing a skin monitor
- Currently suffering with anxiety or panic attacks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart rate
Time frame: 1 month
Heart rate at time points throughout the menstrual cycle
Heart Rate
Time frame: 1 month
Heart rate variability at time points throughout the menstrual cycle
Day of Ovulation
Time frame: 1 month
Day of ovulation determined by urinary LH surge +1 day
Fertile Window
Time frame: 1 month
Fertile window onset determined by E3G surge
Fertile window
Time frame: 1 month
Fertile window closure determined by P3G rise
1 secondary outcome
Comparisons between wrist and chest band monitors
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Johnson study director
SPD Development Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovulation, run by SPD Development Company Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.