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Completed

NCT Number: NCT04008277

Investigation of Heart Rate Variability During the Menstrual Cycle

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.

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Key information

Conditions

Ovulation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

SPD Development Company Ltd.

Bedford, Bedfordshire, MK44 3UP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Heart Rate

    Time frame: 1 month

    Heart rate at time points throughout the menstrual cycle

  2. Heart Rate Variability

    Time frame: 1 month

    Heart rate variability at time points throughout the menstrual cycle

Secondary outcomes

  1. Day of ovulation

    Time frame: 1 month

    Day of ovulation determined by urinary LH surge +1 day

  2. Fertile window

    Time frame: 1 month

    Fertile window onset determined by E3G surge

  3. Fertile window closure

    Time frame: 1 month

    Fertile window closure determined by P3G rise

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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