Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction

NCT ID: NCT05180019

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-09
• Study Completion Date: 2023-05-08

Brief Summary

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

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

Conditions

Self-Evaluation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

SMD ( Self Monitoring Device)

Intervention Type: DEVICE

Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.

Interventions

SMD ( Self Monitoring Device)

Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.

Intervention Type: DEVICE

Other Intervention Names

No names

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IVI Bilbao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcos Ferrando Serrano, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Bilbao

Pedro Royo Manero

Role: PRINCIPAL_INVESTIGATOR

IVI Bilbao

Locations

Ivi Bilbao

Bilbao, Bizkaia, Spain

Countries

Spain

Other Identifiers

2009-BIO-057-PR

Identifier Type: -

Identifier Source: org_study_id