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

EarlySense

Status: Active, not recruiting

Conditions: Reproduction

Treatments: Procedure: Vaginal ultrasound; Device: EarlySense home device; Procedure: Blood Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT02634359

ES-CLC-2015_Prot_1_FERT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

IVF Treatments- Frozen Embryo transfer

Other group

Description:

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

Treatment:

Procedure: Vaginal ultrasound

Device: EarlySense home device

Procedure: Blood Test

IVF Treatments- Clinical Evaluation

Other group

Description:

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

Treatment:

Procedure: Vaginal ultrasound

Device: EarlySense home device

Procedure: Blood Test

No IVF

Other group

Description:

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

Treatment:

Procedure: Vaginal ultrasound

Device: EarlySense home device

Procedure: Blood Test