Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid MappingNCT05505331

Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross Sectional Observational Study

An observational study of Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Three-Dimensional Ultrasonography versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross sectional Observational study Read more about this study

Who is it for?: Ages 12 to 52 years, women only
Conditions the study is for: Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping
What is being tested?: three-Dimensional ultrasonography, Magnetic resonance imaging and myomectomy
Type of treatment: Surgery or procedure
How many people: 50 participants
Where: 1 siteEgypt
Study dates: 15 Aug 2022to Jul 2023
How long will I take part?: 1 Month
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 12 to 52 years
Women only
No healthy volunteers
Child, Adult

Study population: * Age group: child bearing period. * Abnormal uterine bleeding * Dysmenorrhea * Pressure symptoms * Infertility * Pregnancy loss

Who may be able to join

• Age group: child bearing period.
Abnormal uterine bleeding
Dysmenorrhea
Pressure symptoms
Infertility
Pregnancy loss

Who cannot join

• The cardiac implantable electronic device (CIED)
Metallic intraocular foreign bodies
Implantable neurostimulation systems
Cochlear implants/ear implant
Drug infusion pumps
Cerebral artery aneurysm clips
Magnetic dental implants
Artificial limb

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Sohag University Hospital
Sohag, 002

Other trials in Egypt

About this study

Three-Dimensional Ultrasonography versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross sectional Observational study

Read the detailed description

Introduction: Uterine fibroids are the most prevalent gynecologic tumors, affecting nearly (20-30) % of women in the reproductive age group[1] . Approximately 50% of fibroid cases are symptomatic [2] and presented by abnormal uterine bleeding, dysmenorrhea, pressure symptoms, infertility, and pregnancy loss[3]. Fibroids are myometrium-derived monoclonal smooth muscle cancers and their growth is reliant on estrogen and progesterone levels, thus fibroids usually expand during pregnancy or during the use of combined oral contraceptives, and shrink after menopause[4]. Two dimensional ultrasound is the initial test of choice to assess the presence of fibroids in symptomatic patients as it is simple, easy, available and informative [5]. Furthermore, ultrasonography may be sufficient for individuals having conservative therapy. However, Magnetic Resonance Imaging (MRI) gives a more precise evaluation of the quantity, location, and type of fibroids specially in cases with considerable uterine enlargement [6, 7] and submucosal fibroids. Furthermore, MRI can be utilized to differentiate between fibroids and their imitators, such as adenomyosis, ovarian neoplasms, and localized myometrial contractions [8].The introduction of 3D ultrasound in evaluating uterine fibroids appears to be an upcoming and promising prospect [9]. However, the evidence on the role of Three-Dimensional Ultrasonography for fibroid mapping is quite limited up till now.
Aim of the study The aim of this study is to compare the accuracy of 3D ultrasound and MRI for fibroid mapping in women with symptomatic fibroids diagnosed by 2D ultrasound.
Subjects and Methods
Study type: Cross sectional observational study
Inclusion criteria:

Age group: child bearing period.
Abnormal uterine bleeding
Dysmenorrhea
Pressure symptoms
Infertility
Pregnancy loss

Exclusion criteria

The cardiac implantable electronic device (CIED)
Metallic intraocular foreign bodies
Implantable neurostimulation systems
Cochlear implants/ear implant
Drug infusion pumps
Cerebral artery aneurysm clips
Magnetic dental implants
Artificial limb

Methods

This study is a clinical trial that will include all patients fulfilling the eligibility criteria and presented to the department of Obstetrics and Gynecology in Sohag University hospital (Egyptian tertiary referral hospital) from August 2022 to July 2023. The attending physician will explain the nature of the study and all patients will be asked to sign an informed consent. All patients underwent gynecologic and ultrasound examinations, comprising standard 2D followed by 3D ultrasound. For both examinations, a transabdominal and transvaginal US (Voluson,p8) will be used. All symptomatic patients who are diagnosed by conventional 2D scan will be subjected to 3D ultrasound in the mid-cyclic period (late follicular phase) and all the following points will be assessed for fibroid mapping.
Uterine corpus: Measurement of length, anteroposterior diameter, transverse diameter and volume
Serosal contour: Regular versus lobulated
Myometrial walls: Symmetrical versus asymmetrical
Myometrial echogenicity: Homogeneous versus heterogeneous
Myometrial lesions Well defined versus ill defined Number Location (anterior, posterior, fundal, right or left lateral, global) Site (type according to FIGO classification) Size (three perpendicular diameters) Outer lesion-free margin (distance from the serosal surface) Inner lesion-free margin (distance from the endometrial surface) Echogenicity (homogeneous versus heterogeneous; hypo-, iso-, hyper-echogenic)
Sonographic evaluation will be done by the same gynecologist to avoid interpersonal variability. Then all the patients will be subjected pelvic MRI at the radiology department in Sohag University hospital and all cases will be evaluated by the same radiologist using the proper MRI protocol including multiplanar T2-weighted sequences and pre-contrast T1-weighted imaging in either the sagittal or axial plane. Then we will compare the 3D ultrasonographic evaluation and the MRI fibroid mapping with the definite intraoperative findings and retrospectively evaluate the impact of this evaluation on the selected surgical intervention.

Diagnosis of Fibroids by 3D-ultrasonography • This technology captures serial consecutive 2D pictures in three planes: axial, horizontal, and perpendicular. The 2D slice thickness, which may be modified in increments of 2, 4, or 8 mm depending on the individual needs of each investigation, is then translated into volume data, which can subsequently be saved and analyzed in various angles and arbitrary planes[10] . 3D US also offers an accurate coronal view of the uterus, which aids in the delineation of fibroid extension inside the myometrium and into the endometrial cavity. It also depicts the extent and grade of cavity distortion.
Outcome measures:
Primary

The sensitivity and specificity of the 3D-Ultrasonography and MRI for the mapping of different types of symptomatic uterine fibroids according to the final intraoperative diagnosis.

Secondary • The validity of 3D-ultrasonography and MRI of Fibroids for selecting the appropriate way of management.
Statistical analysis: This is a cross sectional study that will include all eligible patients from August 2022 to July 2023. Case by case analysis will be done to test the sensitivity and specificity of each 3D ultrasonographic marker and MRI for fibroid mapping in comparison to final intraoperative findings. Data will be expressed as mean ± standard deviation (SD), unless stated otherwise. Chi-squared test will be used to compare categorical variables and Student's t-test to compare continuous variables. A p-value of <0.05 will be considered statistically significant. STATA v14 (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP) and MedCalc programs and will be used for data analysis.

Conditions: Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping
Being tested: three-Dimensional ultrasonography, Magnetic resonance imaging, myomectomy
Keywords: 3D-Ultrasonography, MRI, Fibroid Mapping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

three-Dimensional ultrasonographyRadiation
transadominal and transvaginal examination
Magnetic resonance imagingRadiation
multiplanar T2-weighted sequences and pre-contrast T1-weighted imaging in either the sagittal or axial plane
myomectomyProcedure or surgery
myoma excision

What is being measured

The primary outcome is the main question the study is designed to answer.

• The sensitivity and specificity of the 3D-Ultrasonography and MRI for the mapping of different types of symptomatic uterine fibroids according to the final intraoperative diagnosis
comparing the ability of 3D-ultrasonography and MRI to detect the exact location of uterine myomas
Measured: from august 2022 to july 2023

Secondary outcomes (1)

• The validity of 3D-ultrasonography and MRI of Fibroids for selecting the appropriate way of management
selecting the type of management according to the 3D-ultrasonography as a cheap method
Measured: august 2023 to july 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 2022Jul 2023

First posted17 Aug 2022
Study start15 Aug 2022
Primary completionMay 2023 (estimated)
Study completionJul 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid MappingStudies of the same condition, open and under way.
More trials run by Sohag UniversityThe sponsor's other registered studies.
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: Case only
Time perspective: Cross-sectional
Enrolment: 50 participants (estimated)
Target duration: 1 Month

IDs, dates and publications

ClinicalTrials.gov ID: NCT05505331
Sponsor's protocol ID: Soh-Med-22-08-02
Status last verified: Aug 2022
First submitted: 16 Aug 2022
Last updated: 17 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Bulun SE. Uterine fibroids. N Engl J Med. 2013 Oct 3;369(14):1344-55. doi: 10.1056/NEJMra1209993. No abstract available.
PubMed 24088094
McLucas B. Diagnosis, imaging and anatomical classification of uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2008 Aug;22(4):627-42. doi: 10.1016/j.bpobgyn.2008.01.006. Epub 2008 Mar 7.
PubMed 18328787
Dueholm M, Lundorf E, Hansen ES, Ledertoug S, Olesen F. Accuracy of magnetic resonance imaging and transvaginal ultrasonography in the diagnosis, mapping, and measurement of uterine myomas. Am J Obstet Gynecol. 2002 Mar;186(3):409-15. doi: 10.1067/mob.2002.121725.
PubMed 11904599
Hossain MZ, Rahman MM, Ullah MM, Mukthadira M, Akter FA, Jahan AB, Jahan F. A Comparative Study of Magnetic Resonance Imaging and Transabdominal Ultrasonography for the Diagnosis and Evaluation of Uterine Fibroids. Mymensingh Med J. 2017 Oct;26(4):821-827.
PubMed 29208870
Murase E, Siegelman ES, Outwater EK, Perez-Jaffe LA, Tureck RW. Uterine leiomyomas: histopathologic features, MR imaging findings, differential diagnosis, and treatment. Radiographics. 1999 Sep-Oct;19(5):1179-97. doi: 10.1148/radiographics.19.5.g99se131179.
PubMed 10489175
Saravelos SH, Jayaprakasan K, Ojha K, Li TC. Assessment of the uterus with three-dimensional ultrasound in women undergoing ART. Hum Reprod Update. 2017 Mar 1;23(2):188-210. doi: 10.1093/humupd/dmw040.
PubMed 28007752
Salim R, Lee C, Davies A, Jolaoso B, Ofuasia E, Jurkovic D. A comparative study of three-dimensional saline infusion sonohysterography and diagnostic hysteroscopy for the classification of submucous fibroids. Hum Reprod. 2005 Jan;20(1):253-7. doi: 10.1093/humrep/deh557. Epub 2004 Oct 21.
PubMed 15498782
Deshmukh SP, Gonsalves CF, Guglielmo FF, Mitchell DG. Role of MR imaging of uterine leiomyomas before and after embolization. Radiographics. 2012 Oct;32(6):E251-81. doi: 10.1148/rg.326125517.
PubMed 23065174
Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003 Jan;188(1):100-7. doi: 10.1067/mob.2003.99.
PubMed 12548202
Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4.
PubMed 7026295

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross Sectional Observational Study
ClinicalTrials.gov ID: NCT05505331
Acronym / sponsor ID: Soh-Med-22-08-02
Conditions: Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping
Keywords: 3D-Ultrasonography, MRI, Fibroid Mapping
Study type: Observational
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Sohag UniversityUniversity, hospital or other
Study start: 15 Aug 2022 (actual)
Primary completion: May 2023 (estimated)
Study completion: Jul 2023 (estimated)
First posted: 17 Aug 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.

Three-Dimensional Ultrasonography versus Magnetic Resonance Imaging for Fibroid Mapping: A Cross sectional Observational study

Detailed description

Introduction: Uterine fibroids are the most prevalent gynecologic tumors, affecting nearly (20-30) % of women in the reproductive age group[1] . Approximately 50% of fibroid cases are symptomatic [2] and presented by abnormal uterine bleeding, dysmenorrhea, pressure symptoms, infertility, and pregnancy loss[3]. Fibroids are myometrium-derived monoclonal smooth muscle cancers and their growth is reliant on estrogen and progesterone levels, thus fibroids usually expand during pregnancy or during the use of combined oral contraceptives, and shrink after menopause[4]. Two dimensional ultrasound is the initial test of choice to assess the presence of fibroids in symptomatic patients as it is simple, easy, available and informative [5]. Furthermore, ultrasonography may be sufficient for individuals having conservative therapy. However, Magnetic Resonance Imaging (MRI) gives a more precise evaluation of the quantity, location, and type of fibroids specially in cases with considerable uterine enlargement [6, 7] and submucosal fibroids. Furthermore, MRI can be utilized to differentiate between fibroids and their imitators, such as adenomyosis, ovarian neoplasms, and localized myometrial contractions [8].The introduction of 3D ultrasound in evaluating uterine fibroids appears to be an upcoming and promising prospect [9]. However, the evidence on the role of Three-Dimensional Ultrasonography for fibroid mapping is quite limited up till now.
Aim of the study The aim of this study is to compare the accuracy of 3D ultrasound and MRI for fibroid mapping in women with symptomatic fibroids diagnosed by 2D ultrasound.
Subjects and Methods
Study type: Cross sectional observational study
Inclusion criteria:

Age group: child bearing period.
Abnormal uterine bleeding
Dysmenorrhea
Pressure symptoms
Infertility
Pregnancy loss

Exclusion criteria

The cardiac implantable electronic device (CIED)
Metallic intraocular foreign bodies
Implantable neurostimulation systems
Cochlear implants/ear implant
Drug infusion pumps
Cerebral artery aneurysm clips
Magnetic dental implants
Artificial limb

Methods

This study is a clinical trial that will include all patients fulfilling the eligibility criteria and presented to the department of Obstetrics and Gynecology in Sohag University hospital (Egyptian tertiary referral hospital) from August 2022 to July 2023. The attending physician will explain the nature of the study and all patients will be asked to sign an informed consent. All patients underwent gynecologic and ultrasound examinations, comprising standard 2D followed by 3D ultrasound. For both examinations, a transabdominal and transvaginal US (Voluson,p8) will be used. All symptomatic patients who are diagnosed by conventional 2D scan will be subjected to 3D ultrasound in the mid-cyclic period (late follicular phase) and all the following points will be assessed for fibroid mapping.
Uterine corpus: Measurement of length, anteroposterior diameter, transverse diameter and volume
Serosal contour: Regular versus lobulated
Myometrial walls: Symmetrical versus asymmetrical
Myometrial echogenicity: Homogeneous versus heterogeneous
Myometrial lesions Well defined versus ill defined Number Location (anterior, posterior, fundal, right or left lateral, global) Site (type according to FIGO classification) Size (three perpendicular diameters) Outer lesion-free margin (distance from the serosal surface) Inner lesion-free margin (distance from the endometrial surface) Echogenicity (homogeneous versus heterogeneous; hypo-, iso-, hyper-echogenic)
Sonographic evaluation will be done by the same gynecologist to avoid interpersonal variability. Then all the patients will be subjected pelvic MRI at the radiology department in Sohag University hospital and all cases will be evaluated by the same radiologist using the proper MRI protocol including multiplanar T2-weighted sequences and pre-contrast T1-weighted imaging in either the sagittal or axial plane. Then we will compare the 3D ultrasonographic evaluation and the MRI fibroid mapping with the definite intraoperative findings and retrospectively evaluate the impact of this evaluation on the selected surgical intervention.

Diagnosis of Fibroids by 3D-ultrasonography • This technology captures serial consecutive 2D pictures in three planes: axial, horizontal, and perpendicular. The 2D slice thickness, which may be modified in increments of 2, 4, or 8 mm depending on the individual needs of each investigation, is then translated into volume data, which can subsequently be saved and analyzed in various angles and arbitrary planes[10] . 3D US also offers an accurate coronal view of the uterus, which aids in the delineation of fibroid extension inside the myometrium and into the endometrial cavity. It also depicts the extent and grade of cavity distortion.
Outcome measures:
Primary

The sensitivity and specificity of the 3D-Ultrasonography and MRI for the mapping of different types of symptomatic uterine fibroids according to the final intraoperative diagnosis.

Secondary • The validity of 3D-ultrasonography and MRI of Fibroids for selecting the appropriate way of management.
Statistical analysis: This is a cross sectional study that will include all eligible patients from August 2022 to July 2023. Case by case analysis will be done to test the sensitivity and specificity of each 3D ultrasonographic marker and MRI for fibroid mapping in comparison to final intraoperative findings. Data will be expressed as mean ± standard deviation (SD), unless stated otherwise. Chi-squared test will be used to compare categorical variables and Student's t-test to compare continuous variables. A p-value of <0.05 will be considered statistically significant. STATA v14 (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP) and MedCalc programs and will be used for data analysis.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Target follow-up: 1 Month

Who may qualify

Ages: 12 to 52 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: * Age group: child bearing period. * Abnormal uterine bleeding * Dysmenorrhea * Pressure symptoms * Infertility * Pregnancy loss

Key inclusion criteria (6 listed)

• Age group: child bearing period.

Key exclusion criteria (8 listed)

• The cardiac implantable electronic device (CIED)

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
three-Dimensional ultrasonographytransadominal and transvaginal examination	Radiation	–
Magnetic resonance imagingmultiplanar T2-weighted sequences and pre-contrast T1-weighted imaging in either the sagittal or axial plane	Radiation	–
myomectomymyoma excision	Procedure or surgery	–

Primary outcome

• The sensitivity and specificity of the 3D-Ultrasonography and MRI for the mapping of different types of symptomatic uterine fibroids according to the final intraoperative diagnosis
Time frame: from august 2022 to july 2023
comparing the ability of 3D-ultrasonography and MRI to detect the exact location of uterine myomas

1 secondary outcome

• The validity of 3D-ultrasonography and MRI of Fibroids for selecting the appropriate way of management
Time frame: august 2023 to july 2023

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
Background: PubMed 24088094Bulun SE. Uterine fibroids. N Engl J Med. 2013 Oct 3;369(14):1344-55. doi: 10.1056/NEJMra1209993. No abstract available.
Background: PubMed 18328787McLucas B. Diagnosis, imaging and anatomical classification of uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2008 Aug;22(4):627-42. doi: 10.1016/j.bpobgyn.2008.01.006. Epub 2008 Mar 7.
Background: PubMed 11904599Dueholm M, Lundorf E, Hansen ES, Ledertoug S, Olesen F. Accuracy of magnetic resonance imaging and transvaginal ultrasonography in the diagnosis, mapping, and measurement of uterine myomas. Am J Obstet Gynecol. 2002 Mar;186(3):409-15. doi: 10.1067/mob.2002.121725.
Background: PubMed 29208870Hossain MZ, Rahman MM, Ullah MM, Mukthadira M, Akter FA, Jahan AB, Jahan F. A Comparative Study of Magnetic Resonance Imaging and Transabdominal Ultrasonography for the Diagnosis and Evaluation of Uterine Fibroids. Mymensingh Med J. 2017 Oct;26(4):821-827.
Background: PubMed 10489175Murase E, Siegelman ES, Outwater EK, Perez-Jaffe LA, Tureck RW. Uterine leiomyomas: histopathologic features, MR imaging findings, differential diagnosis, and treatment. Radiographics. 1999 Sep-Oct;19(5):1179-97. doi: 10.1148/radiographics.19.5.g99se131179.
Background: PubMed 28007752Saravelos SH, Jayaprakasan K, Ojha K, Li TC. Assessment of the uterus with three-dimensional ultrasound in women undergoing ART. Hum Reprod Update. 2017 Mar 1;23(2):188-210. doi: 10.1093/humupd/dmw040.
Background: PubMed 15498782Salim R, Lee C, Davies A, Jolaoso B, Ofuasia E, Jurkovic D. A comparative study of three-dimensional saline infusion sonohysterography and diagnostic hysteroscopy for the classification of submucous fibroids. Hum Reprod. 2005 Jan;20(1):253-7. doi: 10.1093/humrep/deh557. Epub 2004 Oct 21.
Results publication: PubMed 23065174Deshmukh SP, Gonsalves CF, Guglielmo FF, Mitchell DG. Role of MR imaging of uterine leiomyomas before and after embolization. Radiographics. 2012 Oct;32(6):E251-81. doi: 10.1148/rg.326125517.
Results publication: PubMed 12548202Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003 Jan;188(1):100-7. doi: 10.1067/mob.2003.99.
Results publication: PubMed 7026295Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Three-Dimensional Ultrasonography Versus Magnetic Resonance Imaging for Fibroid Mapping, run by Sohag University at 1 site in Egypt.

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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. 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 Egypt. 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?

Results are not available in the source record.

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?

• The sensitivity and specificity of the 3D-Ultrasonography and MRI for the mapping of different types of symptomatic uterine fibroids according to the final intraoperative diagnosis (time frame: from august 2022 to july 2023). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05505331, which also lists 10 linked publications.

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 17 Aug 2022.