Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Self Monitoring Device (SMD) for Trasvaginal Ultrasound in Reproduction

Conditions
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Self-Evaluation

Intervention / Treatment
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* Device: SMD ( Self Monitoring Device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form dated and signed Female, aged 18 years or above Patient undergoing COS for IVF/ICSI, oocyte vitrification or oocyte donation cycles in IVIRMA Bilbao clinic Willing to comply with all study requirements Exclusion Criteria: Simultaneous participation in another clinical study that, at researcher's criteria, could interfere with the results of this study. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient COS IVI Bilbao<br>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)<br>* Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.<br>* Other names: No names;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trasvaginal ultrasound 3D, Self-Monitoring Device, Pelvic ultrasound volume, risks, Trasvaginal ultrasound 2D