Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction (AUTOECOSMD)

Self Monitoring Device (SMD) for Trasvaginal Ultrasound in Reproduction

Serial ultrasound (US) examinations are performed to assess the number and size of follicles during controlled ovarian stimulation (COS). Ovarian folliculometry during COS is the most frequent ultrasound procedure daily performed, an also a highly time consuming and reiterative process.

However, it has been shown that manual measurement of follicles with 2D US is often inaccurate and subject to significant intra- and interobserver variability

In addition, a follicle is a three-dimensional (3D) structure and its volume is the most accurate measure of its size. Therefore, 3D transvaginal ultrasound in gynaecology and reproductive medicine has supposed a great advance, because it makes possible to obtain ovarian volumes during controlled ovarian stimulation

Study Overview

• Status: Recruiting
• Conditions: Self-Evaluation
• Intervention / Treatment: Device: SMD ( Self Monitoring Device)

Detailed Description

At each visit, IVIRMA Bilbao doctors (MF, CF) will perform routine folliculometry to the patients (standard 2D manual ultrasound) to control the ovarian stimulation. In this exam, follicles will be counted and measured (mean diameter) in millimeters, as usual clinical practice,

After the standard folliculometry, will request the patient for self-performing scan (3Dultrasound)

After each patient self-capture, IVIRMA Bilbao gynaecologists will check the saved volume (3D multiplanar mode) using ITKSnap viewer to ensure the correct acquisition saving (complete ovaries and uterus captured inside without artifacts) in order to compare 2D ultrasound (clinical reference) for number and mean follicle diameter estimations, with 3D multiplanar ultrasound (obtained with SMD) GMDN (Global Medical Device Nomenclature): 40761

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Marcos Ferrando Serrano, MD; Phone Number: +34 944 80 60 20; Email: ivibilbao@ivirma.com
• Study Contact Backup: Name: Fernando Quintana Ferraz; Phone Number: +34 944 80 60 20; Email: ivibilbao@ivirma.com

Study Locations

• Spain
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48940
      • Recruiting
      • IVI Bilbao
      • Contact: Fernando Quintana; Phone Number: 944806020; Email: fernando.quintana@ivirma.com
      • Contact: Marcos Ferrando; Phone Number: 944806020; Email: marcos.ferrando@ivirma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The target population includes any women who wants to carry out a COS for IVF/ICSI, oocyte donor or oocyte vitrification treatment

Description

Inclusion Criteria:

1. Informed consent form dated and signed
2. Female, aged 18 years or above
3. Patient undergoing COS for IVF/ICSI, oocyte vitrification or oocyte donation cycles in IVIRMA Bilbao clinic
4. Willing to comply with all study requirements

Exclusion Criteria:

1. Simultaneous participation in another clinical study that, at researcher's criteria, could interfere with the results of this study.
2. Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient COS IVI Bilbao; Patients will come to the IVIRMA Bilbao clinic to start their respective ART cycles (vitrification, IVF/ICSI, donors) following usual clinical practice.	Device: SMD ( Self Monitoring Device); Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.; Other Names: No names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SMD validation for clinical use	After the standard folliculometry, will request the patient for self-performing scan (3D ultrasound)	Three months
Determination of the risks during use SMD	Patients will have phone connection to call the nurse if any problems happen or when they finish the scan.	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's perception as a user of the SMD	To know the patient's perception as a user of the SMD by means of a satisfaction questionnaire	Three months
To recopilate the pelvic ultrasound volumes	To recopilate the pelvic ultrasound volumes (uterus and ovaries inside) during COS exams for posterior development of an automated segmentation system (of the uterus and the ovaries) in the context of a next project, conditioned to the obtention of satisfactory outcomes after the finalization of the present study.	Three months

Collaborators and Investigators

• Sponsor: IVI Bilbao
• Investigators: Principal Investigator: Marcos Ferrando Serrano, MD, IVI Bilbao; Principal Investigator: Pedro Royo Manero, IVI Bilbao

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Trasvaginal ultrasound 3D; Self-Monitoring Device; Pelvic ultrasound volume; risks; Trasvaginal ultrasound 2D
• Other Study ID Numbers: 2009-BIO-057-PR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No