Evaluation of EarlySense for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment

Protocol for Evaluation of EarlySense - a Contact-less Heart and Respiration Device for Monitoring Ovulation Cycles and Detection of Early Stages of Pregnancy in Home Environment

The study objective is to collect data to assess the accuracy and reliability of Earlysense fertility cycle monitoring performance vs. acceptable known reference methods such as blood tests and intra-vaginal Ultrasound currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms.

Study Overview

• Status: Active, not recruiting
• Conditions: Reproduction
• Intervention / Treatment: Device: EarlySense home device; Procedure: Vaginal ultrasound; Procedure: Blood Test

Detailed Description

The study objective is to assess the accuracy and reliability of Earlysense cycle monitoring to detect ovulation and implantation vs. acceptable known reference methods including blood tests and Ultrasound examination that are currently used as validated methods to detect ovulation and pregnancy. In addition the collected data will be used to further enhance and improve the existing algorithms that detect menses.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Herzelia, Israel
    • Herzelia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age 18 years ≤ 40 years
2. Healthy women with no significant background illness or Consenting women that arrive to IVF clinic for frozen embryo transfer on spontaneous cycle, or Consenting women that arrive for cycle evaluation or insemination on spontaneous cycle (infertile women).
3. Healthy women volunteers with regular menstrual cycles - not using contraceptives
4. Is willing to sign the consent form.
5. Sleeps on a mattress which allows placing a sensor under that mattress(so Earlysense sensor can be inserted under the mattress)
6. Regular cycle

Exclusion Criteria:

• Age < 18 years or > 40 years old
• Is not willing to sign the consent form.
• Does not sleep on a mattress that allows placing EarlySense sensor under it .(e.g., Futon0 Taking any significant medication or have major chronic diseases: e.g. Diabetes, CHF, COPD, Heart disease or pacemaker
• Taking pills (oral contraceptives or medical IUD w. progesterone)
• Women with irregular cycles (PCOS) or un-ovulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IVF Treatments- Frozen Embryo transfer; Consenting women that arrive to IVF clinic for frozen embryo transfer on spontaneous cycle Study Intervention: Ultrasound and Blood test to detect Ovulation. At home, HR, RR and movements will be contactlessly measured using EarlySense home device	Device: EarlySense home device; Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF; Procedure: Vaginal ultrasound; Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF; Procedure: Blood Test; Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF
Other: IVF Treatments- Clinical Evaluation; Consenting women that arrive for cycle evaluation or insemination on spontaneous cycle (infertile women). Study Intervention: Ultrasound and Blood test to detect Ovulation At home, HR, RR and movements will be contactlessly measured using EarlySense home device	Device: EarlySense home device; Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF; Procedure: Vaginal ultrasound; Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF; Procedure: Blood Test; Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF
Other: No IVF; Healthy women volunteers with regular menstrual cycles - not using contraceptives Study Intervention: Ultrasound and Blood test to detect Ovulation At home, HR, RR and movements will be contactlessly measured using EarlySense home device	Device: EarlySense home device; Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF; Procedure: Vaginal ultrasound; Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF; Procedure: Blood Test; Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detecting Ovulation or Early Pregnancy	Determine the effectiveness of the EarlySense system to detect ovulation and early stages of pregnancy. We would like to see what were the differences in measurements on the EarlySense System, on the dates of Ovulation (according to Ultrasound and Blood Test)	3 months

Collaborators and Investigators

• Sponsor: EarlySense Ltd.
• Investigators: Study Director: Dalia Argaman, EarlySense Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: ES-CLC-2015_Prot_1_FERT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided