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

Not Applicable

Active, not recruiting

• Conditions: Reproduction
• Interventions: Device: EarlySense home device; Procedure: Vaginal ultrasound; Procedure: Blood Test

• Registration Number: NCT02634359
• Lead Sponsor: EarlySense Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-18
• Status Verified: 2018-01
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No IVF	Vaginal ultrasound	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
IVF Treatments- Frozen Embryo transfer	EarlySense home device	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
IVF Treatments- Clinical Evaluation	Vaginal ultrasound	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
IVF Treatments- Frozen Embryo transfer	Vaginal ultrasound	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
IVF Treatments- Frozen Embryo transfer	Blood Test	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
No IVF	EarlySense home device	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
IVF Treatments- Clinical Evaluation	EarlySense home device	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
IVF Treatments- Clinical Evaluation	Blood Test	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
No IVF	Blood Test	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

Primary Outcome Measures

Name	Time	Method
Detecting Ovulation or Early Pregnancy	3 months	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)

Trial Locations

Locations (1)

Herzelia Medical Center; 🇮🇱 Herzelia, Israel