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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Reproduction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

EarlySense home device

Intervention Type DEVICE

Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Vaginal ultrasound

Intervention Type PROCEDURE

Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Blood Test

Intervention Type PROCEDURE

Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

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

Group Type OTHER

EarlySense home device

Intervention Type DEVICE

Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Vaginal ultrasound

Intervention Type PROCEDURE

Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Blood Test

Intervention Type PROCEDURE

Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

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

Group Type OTHER

EarlySense home device

Intervention Type DEVICE

Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Vaginal ultrasound

Intervention Type PROCEDURE

Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Blood Test

Intervention Type PROCEDURE

Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Interventions

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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

Intervention Type DEVICE

Vaginal ultrasound

Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Intervention Type PROCEDURE

Blood Test

Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes