AUTOECOSMD: Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction

Sponsor

IVI Bilbao (Other)

Overall Status

Recruiting

CT.gov ID

NCT05180019

Collaborator

(none)

600

Enrollment

Location

4.6

Anticipated Duration (Months)

129.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Self-Evaluation	Device: SMD ( Self Monitoring Device)

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Self Monitoring Device (SMD) for Trasvaginal Ultrasound in Reproduction

Actual Study Start Date :

Feb 9, 2022

Anticipated Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: SMD ( Self Monitoring Device) Automated 3D ultrasound based follicullometry with SMD self-performed by the patient. Other Names: No names

Arm

Intervention/Treatment

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.

Device: SMD ( Self Monitoring Device)

Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.

Other Names:

No names

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ivi Bilbao	Bilbao	Bizkaia	Spain	48940

Sponsors and Collaborators

IVI Bilbao

Investigators

Principal Investigator: Marcos Ferrando Serrano, MD, IVI Bilbao
Principal Investigator: Pedro Royo Manero, IVI Bilbao

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IVI Bilbao

ClinicalTrials.gov Identifier:

NCT05180019

Other Study ID Numbers:

2009-BIO-057-PR

First Posted:

Jan 6, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by IVI Bilbao

Trasvaginal ultrasound 3D

Self-Monitoring Device

Pelvic ultrasound volume

risks

Trasvaginal ultrasound 2D

Study Results

No Results Posted as of Mar 31, 2022