Self-EvaluationAUTOECOSMDNCT05180019
Self Monitoring Device Fortrasvaginal Ultrasound in Reproduction
An observational study of Self-Evaluation, run by IVI Bilbao at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Self-Evaluation
- What is being tested?
- SMD ( Self Monitoring Device)
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2022to 8 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: The target population includes any women who wants to carry out a COS for IVF/ICSI, oocyte donor or oocyte vitrification treatment
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self Monitoring Device (SMD) for Trasvaginal 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
Read the 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
- Conditions
- Self-Evaluation
- Being tested
- SMD ( Self Monitoring Device)
- Keywords
- Trasvaginal ultrasound 3D, Self-Monitoring Device, Pelvic ultrasound volume, risks, Trasvaginal ultrasound 2D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMD ( Self Monitoring Device)Device
Also called No names
Automated 3D ultrasound based follicullometry with SMD self-performed by the patient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SMD ( Self Monitoring Device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SMD validation for clinical use
After the standard folliculometry, will request the patient for self-performing scan (3D ultrasound)
Measured: 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.
Measured: Three months
Secondary outcomes (2)
Patient's perception as a user of the SMD
To know the patient's perception as a user of the SMD by means of a satisfaction questionnaire
Measured: Three months
To recopilate the pelvic ultrasound volumes
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start9 Feb 2022
- Primary completion8 May 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Bilbao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcos Ferrando Serrano, MD, Principal investigator, IVI BilbaoPedro Royo Manero, Principal investigator, IVI Bilbao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180019
- Sponsor's protocol ID
- 2009-BIO-057-PR
- Acronym
- AUTOECOSMD
- Status last verified
- Apr 2025
- First submitted
- 17 Dec 2021
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Monitoring Device (SMD) for Trasvaginal Ultrasound in Reproduction
- ClinicalTrials.gov ID
- NCT05180019
- Acronym / sponsor ID
- AUTOECOSMD / 2009-BIO-057-PR
- Conditions
- Self-Evaluation
- Keywords
- Trasvaginal ultrasound 3D, Self-Monitoring Device, Pelvic ultrasound volume, risks, Trasvaginal ultrasound 2D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- IVI BilbaoUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient COS IVI Bilbao | – | Device: SMD ( Self Monitoring Device)Patients will come to the IVIRMA Bilbao clinic to start their respective ART cycles (vitrification, IVF/ICSI, donors) following usual clinical practice. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The target population includes any women who wants to carry out a COS for IVF/ICSI, oocyte donor or oocyte vitrification treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMD ( Self Monitoring Device)Also: No namesAutomated 3D ultrasound based follicullometry with SMD self-performed by the patient. | Device | Patient COS IVI Bilbao |
Primary outcome
SMD validation for clinical use
Time frame: Three months
After the standard folliculometry, will request the patient for self-performing scan (3D ultrasound)
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.
2 secondary outcomes
Patient's perception as a user of the SMD
Time frame: Three months
To recopilate the pelvic ultrasound volumes
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcos Ferrando Serrano, MD principal investigator
IVI Bilbao
Pedro Royo Manero principal investigator
IVI Bilbao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self-Evaluation, run by IVI Bilbao at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SMD validation for clinical use (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.