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

NCT02634359 | Unknown DMC

• 1 other identifier: ES-CLC-2015_Prot_1_FERT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Reproduction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

IVF Treatments- Frozen Embryo transfer

OTHER

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; Procedure: Vaginal ultrasound; Procedure: Blood Test

IVF Treatments- Clinical Evaluation

OTHER

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; Procedure: Vaginal ultrasound; Procedure: Blood Test

No IVF

OTHER

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; Procedure: Vaginal ultrasound; Procedure: Blood Test

Interventions

EarlySense home device DEVICE

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

IVF Treatments- Clinical Evaluation; IVF Treatments- Frozen Embryo transfer; No IVF

Vaginal ultrasound PROCEDURE

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

IVF Treatments- Clinical Evaluation; IVF Treatments- Frozen Embryo transfer; No IVF

Blood Test PROCEDURE

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

IVF Treatments- Clinical Evaluation; IVF Treatments- Frozen Embryo transfer; No IVF

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EarlySense Ltd.: lead

Study Sites (1)

Herzelia Medical Center

Herzelia, Israel

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dalia Argaman

  EarlySense Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 18, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 29, 2022

Record last verified: 2018-01

Locations

IL (1)