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Completed

NCT Number: NCT05180019

Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction

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

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Key information

Conditions

Self-Evaluation

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Ivi Bilbao

Bilbao, Bizkaia, 48940, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SMD ( Self Monitoring Device)

Device

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

Other names: No names

Primary outcomes

  1. SMD validation for clinical use

    Time frame: Three months

    After the standard folliculometry, will request the patient for self-performing scan (3D ultrasound)

  2. Determination of the risks during use SMD

    Time frame: Three months

    Patients will have phone connection to call the nurse if any problems happen or when they finish the scan.

Secondary outcomes

  1. Patient's perception as a user of the SMD

    Time frame: Three months

    To know the patient's perception as a user of the SMD by means of a satisfaction questionnaire

  2. To recopilate the pelvic ultrasound volumes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

IVI Bilbao

Other

Registry information

Official study title

Self Monitoring Device (SMD) for Trasvaginal Ultrasound in Reproduction

Acronym: AUTOECOSMD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2022
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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