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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMD ( Self Monitoring Device) | Device | Automated 3D ultrasound based follicullometry with SMD self-performed by the patient. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The target population includes any women who wants to carry out a COS for IVF/ICSI, oocyte donor or oocyte vitrification treatment
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| Name | Affiliation | Role |
|---|---|---|
| Marcos Ferrando Serrano, MD | IVI Bilbao | Principal Investigator |
| Pedro Royo Manero | IVI Bilbao | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ivi Bilbao | Bilbao | Bizkaia | 48940 | Spain |
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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 |