CompletedNot Applicable

Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction

Spain101 participantsStarted 2022-02-09

Plain-language 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

Who can participate

Age range18 Years – 49 Years

SexFEMALE

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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.

What they're measuring

SMD validation for clinical use

Timeframe: Three months

Determination of the risks during use SMD

Timeframe: Three months

Trial details

NCT IDNCT05180019

SponsorIVI Bilbao

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-05-08

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