NCT05180019

Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction

Self Monitoring Device (SMD) for Trasvaginal Ultrasound in Reproduction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: IVI Bilbao · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	SMD ( Self Monitoring Device)	Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.

Timeline

• Start date: 2022-02-09
• Primary completion: 2023-05-08
• Completion: 2023-05-08
• First posted: 2022-01-06
• Last updated: 2025-05-02

Locations

1 site across 1 country: Spain