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

Launched by RABIN MEDICAL CENTER · Aug 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the PulseNmore FC, which helps women undergoing in vitro fertilization (IVF) treatments by allowing them to perform certain ultrasound scans on themselves with guidance from a trained professional. The goal is to see if this device is safe and effective compared to traditional in-clinic ultrasound scans. The study will involve 100 women aged 18 to 43 who are receiving fertility treatments at Belinson Hospital and who can perform these scans on their own after some training.

Participants in the trial will follow the normal schedule of ultrasound scans during their IVF treatment, which typically lasts about two weeks. They may be asked to use the PulseNmore FC device in a clinician-guided mode, and if they have used it before, they may also try a new app-guided mode. It’s important to note that participants must have normal pelvic anatomy and be comfortable performing these self-scans. The study will help researchers understand if this new approach can make fertility treatments easier and more accessible for women.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women undergoing fertility treatments in the IVF unit of Belinson Hospital that require serial transvaginal ultrasound scans.
• • Female age 18-43
• • Normal pelvic anatomy
• • Capable and willing to perform self vaginal ultrasound measurements.
• • Ability to understand and sign the informed consent.
• • Ability to read and understand instructions that are required for equipment use
• • Ability to identify the uterus and ovaries on the device screen by the end of the training session.
• • Patient can read and understand Hebrew or English
• Exclusion Criteria:
• • Known uterine malformations.
• • Known ovarian pathologies.
• • Known or suspected diminished ovarian reserve parameters (basal FSH\> 10 IU/L, AFC \<7 or serum AMH \< 1ng/ml), unless 9 or more oocytes were aspirated in a previous ART cycle within the last 3 months.
• • Presence of hydrosalpinx.
• • Intraabdominal adhesions.
• • Previous lower abdominal surgery.
• • BMI \>40
• • Unable to use the trans-vaginal device.
• • Subjects allergic to the ultrasound probe materials.
• • Significant malposition of the ovaries.