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

Reproduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02634359
• Other study ID #: ES-CLC-2015_Prot_1_FERT
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2025

Study information

• Verified date: January 2018
• Source: EarlySense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Reproduction

Intervention

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

Locations

Country	Name	City	State
Israel	Herzelia Medical Center	Herzelia

Sponsors (1)

Lead Sponsor	Collaborator
EarlySense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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