Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction

NCT05180019 | Completed

• 1 other identifier: 2009-BIO-057-PR
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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

Conditions

Self-Evaluation

Keywords

Trasvaginal ultrasound 3D; Self-Monitoring Device; Pelvic ultrasound volume; risks; Trasvaginal ultrasound 2D

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient's perception as a user of the SMD

  Three months

• To recopilate the pelvic ultrasound volumes

  Three months

Study Arms (1)

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)

Interventions

SMD ( Self Monitoring Device) DEVICE

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

Also known as: No names

Patient COS IVI Bilbao

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IVI Bilbao: lead

Study Sites (1)

Ivi Bilbao

Bilbao, Bizkaia, 48940, Spain

Location

Study Officials

• Marcos Ferrando Serrano, MD

  IVI Bilbao

  PRINCIPAL INVESTIGATOR

• Pedro Royo Manero

  IVI Bilbao

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: February 9, 2022
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)