Clinical trial NCT05180019: Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction
Official title: Self Monitoring Device (SMD) for Trasvaginal Ultrasound in Reproduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Self-Evaluation
Keywords: Trasvaginal ultrasound 3D
Self-Monitoring Device
Pelvic ultrasound volume
risks
Trasvaginal ultrasound 2D
Lead sponsor: IVI Bilbao
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 101
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population includes any women who wants to carry out a COS for IVF/ICSI, oocyte donor or oocyte vitrification treatment

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

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.

Primary outcomes:
measure: SMD validation for clinical use
timeFrame: Three months
measure: Determination of the risks during use SMD
timeFrame: Three months
Secondary outcomes:
measure: Patient's perception as a user of the SMD
timeFrame: Three months
measure: To recopilate the pelvic ultrasound volumes
timeFrame: Three months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Ivi Bilbao
state: Bizkaia
Study officials:
affiliation: IVI Bilbao
name: Marcos Ferrando Serrano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IVI Bilbao
name: Pedro Royo Manero
role: PRINCIPAL_INVESTIGATOR
References: