Self-Evaluation
Conditions
Keywords
Trasvaginal ultrasound 3D, Self-Monitoring Device, Pelvic ultrasound volume, risks, Trasvaginal ultrasound 2D
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
Interventions
DEVICESMD ( Self Monitoring Device)
Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.
Sponsors
IVI Bilbao
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SMD validation for clinical use | Three months | After the standard folliculometry, will request the patient for self-performing scan (3D ultrasound) |
| Determination of the risks during use SMD | Three months | Patients will have phone connection to call the nurse if any problems happen or when they finish the scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's perception as a user of the SMD | Three months | To know the patient's perception as a user of the SMD by means of a satisfaction questionnaire |
| To recopilate the pelvic ultrasound volumes | Three months | 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. |
Countries
Spain
Outcome results
None listed