Investigation of Heart Rate Variability During the Menstrual Cycle

Ovulation Clinical Trial

Official title:

Investigation of Heart Rate Variability During the Menstrual Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008277
• Other study ID #: PROTOCOL-1039
• Status: Completed
• Start date: July 19, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, women will be required to wear a heart rate monitor continuously 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.

Description:

This pilot 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 heart rate monitor continuously and collect daily early morning urine samples throughout one menstrual cycle.

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 monitor including heart rate and heart rate variability will be downloaded for comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and over

• Regular menstrual cycles

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ovulation

Locations

Country	Name	City	State
United Kingdom	SPD Development Company Ltd.	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	Heart rate at time points throughout the menstrual cycle	1 month
Primary	Heart Rate Variability	Heart rate variability at time points throughout the menstrual cycle	1 month
Secondary	Day of ovulation	Day of ovulation determined by urinary LH surge +1 day	1 month
Secondary	Fertile window	Fertile window onset determined by E3G surge	1 month
Secondary	Fertile window closure	Fertile window closure determined by P3G rise	1 month