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The Use of PulseNmore FC Device in Patients Undergoing IVF Treatment A Study to Evaluate the Safety and the Efficacy

NCT05485623 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-01-09

No results posted yet for this study

Summary

This is a single center, interventional, longitudinal prospective, of 100 women undergoing fertility treatment in the IVF unit of Belinson Hospital. The study will examine the performance of the FC Clinician-Guided (CG) transvaginal scan done with Pulsenmore FC device, performed by patients with remote guidance of a professional sonographer. Experienced patients who already used the FC device for one cycle in a CG mode, can be re-enrolled for testing also the App-Guided mode of the device. All FC scans will be compared to the conventional ultrasound system in-clinic scan (ground truth - GT). Subjects will participate in the study for one IVF cycle (or 2 cycles if patient is re-enrolled also for the APP mode), an estimated study period of 2 weeks, and scan schedule protocol will follow the standard of care scan schedule for IVF treatment. The last visit will be defined when the attending physician concludes that the follicle requitement potential of the cycle has been achieved and the patient is ready for oocyte aspiration.

Conditions

  • Women Undergoing Fertility Treatments

Interventions

DEVICE

PulseNmore FC

Pulsenmore Ltd. has developed a small portable vaginal ultrasound device for personal use at home. The ultrasound device allows to scan and assess both the uterus and the ovaries. This ultrasound device connects to a smartphone and a user-friendly application simplifies its use. This ultrasound device is based on the company's 'Pulsenmore ES ultrasound system' which is a small abdominal ultrasound device for home and self-use by pregnant women. This (abdominal) ultrasound device allows scanning and detection of fetal pulse, count fetal movements, assess the amount of amniotic fluid and more. The device is an abdominal ultrasound probe that connects to a smartphone using a specially designed socket. The main difference between the devices is the different design of the ultrasound vaginal probe. The device consists of 2 components: a cradle and an application (software). The cradle contains the electronic components and the ultrasound probe.

Sponsors & Collaborators

  • PulseNmore

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-07-30
Completion
2025-12-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05485623 on ClinicalTrials.gov