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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Reproduction

Intervention / Treatment
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* Device: EarlySense home device
* Procedure: Vaginal ultrasound
* Procedure: Blood Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years ≤ 40 years 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). Healthy women volunteers with regular menstrual cycles - not using contraceptives Is willing to sign the consent form. Sleeps on a mattress which allows placing a sensor under that mattress(so Earlysense sensor can be inserted under the mattress) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IVF Treatments- Frozen Embryo transfer<br>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<br>* Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>Procedure: Vaginal ultrasound<br>* Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>Procedure: Blood Test<br>* Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>|
| Other: IVF Treatments- Clinical Evaluation<br>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<br>* Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>Procedure: Vaginal ultrasound<br>* Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>Procedure: Blood Test<br>* Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>|
| Other: No IVF<br>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<br>* Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>Procedure: Vaginal ultrasound<br>* Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>Procedure: Blood Test<br>* Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF<br>|

What is the study measuring?
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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 |