Diagnostic Accuracy of 3D/4D Transvaginal Ultrasound Compared With MRI for Müllerian Uterine Anomalies: A Prospective Study Using Hysteroscopic Confirmation for Septate Uterus

Diagnostic Accuracy of 3D/4D Transvaginal Ultrasound Compared With MRI for Müllerian Uterine Anomalies: A Prospective Study Using Hysteroscopic Confirmation for Septate Uterus | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Diagnostic Accuracy of 3D/4D Transvaginal Ultrasound Compared With MRI for Müllerian Uterine Anomalies: A Prospective Study Using Hysteroscopic Confirmation for Septate Uterus Firat Buyuktaskin, Gizem Işık, Serhan Can Iscan, ismail Güler, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8231443/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective: To compare the diagnostic accuracy and concordance of three-dimensional/four-dimensional (3D/4D) ultrasonography and magnetic resonance imaging (MRI) in detecting Müllerian duct anomalies (MDAs) and to evaluate their impact on surgical decision-making. Methods: This prospective observational study included 32 patients who presented to the infertility or gynecology outpatient clinics at Gazi University Hospital between November 2016 and November 2017. All patients underwent both 3D/4D transvaginal ultrasonography (Voluson E6, GE Healthcare) and pelvic MRI (3T Verio, Siemens). Diagnoses were classified according to the American Society of Reproductive Medicine (ASRM, 1988) criteria. Concordance between the two imaging modalities was evaluated using the kappa (κ) statistic. Results: Of the 32 enrolled patients, 25 completed both imaging studies. Overall concordance between 3D/4D ultrasonography and MRI was 40% (κ = 0.266, p < 0.001), indicating low-to-moderate agreement. The most common diagnosis with 3D/4D ultrasonography was septate uterus (56%), compared with 20% by MRI. Among 13 patients who underwent surgery, 12 were correctly diagnosed as having septate uterus by 3D/4D ultrasonography (positive predictive value, 92.3%), while MRI correctly identified four (30.8%). Surgical decisions were based on 3D/4D ultrasonography in 69.2% of discordant cases and on MRI in 30.8%. Conclusion: Although MRI remains the reference standard for evaluating MDAs, 3D/4D ultrasonography demonstrated strong clinical value in guiding surgical management and offered advantages of accessibility, real-time assessment, and lower cost. We recommend that 3D/4D ultrasonography be performed by the operating gynecologist prior to surgical planning. Larger randomized studies are warranted to validate these findings. Figures Figure 1 Figure 2 Figure 3 Introduction Congenital uterine malformations arise from incomplete fusion, resorption, or development of the Müllerian ducts. The prevalence of Müllerian duct anomalies (MDAs) in the general population is approximately 4%, increasing to 6–7% among women with infertility or recurrent pregnancy loss. Accurate diagnosis is essential because MDAs are associated with adverse reproductive outcomes, including infertility, miscarriage, and preterm delivery [1]. Historically, hysterosalpingography (HSG) was the primary diagnostic tool, but its diagnostic accuracy is limited to about 55% and it exposes patients to radiation and potential infection [2]. While combined hysteroscopy and laparoscopy remain the gold standard for definitive diagnosis, their invasive nature and cost limit widespread use [7]. Therefore, non-invasive imaging modalities have gained importance [3]. Magnetic resonance imaging (MRI) has been shown to provide excellent anatomical detail and high diagnostic accuracy—reported sensitivity and specificity up to 100% in some studies [6,8]. However, its limited availability, cost, and requirement for radiologic interpretation restrict its routine use. In contrast, three-dimensional (3D) and four-dimensional (4D) ultrasonography are widely accessible, cost-effective, and allow real-time evaluation of uterine morphology, particularly the fundal contour, which is critical for differentiating septate from bicornuate uteri [5]. Previous studies have demonstrated high reproducibility and good correlation between 3D ultrasonography and surgical findings, suggesting that it may serve as a reliable, non-invasive alternative to MRI in selected patients [1, 5, 13, 21, 22]. The present study aims to compare the diagnostic concordance of 3D/4D ultrasonography and MRI in detecting Müllerian duct anomalies and to assess their respective influences on clinical decision-making regarding surgery. Methods Study Design and Participants This was a prospective observational study conducted at the Department of Obstetrics and Gynecology, Gazi University School of Medicine (Ankara, Turkey), between November 2016 and November 2017. The study was approved by the Gazi University Ethics Committee (Approval No: GU-516/2015), and written informed consent was obtained from all participants. Thirty-two women who presented to either the infertility or general gynecology outpatient clinics with suspected Müllerian duct anomalies (MDAs) were enrolled. Indications for imaging included infertility, recurrent pregnancy loss, abnormal uterine bleeding, or incidental findings on two-dimensional (2D) ultrasonography. Inclusion and Exclusion Criteria Inclusion criteria were reproductive-aged women with suspected uterine anomalies on clinical examination, 2D ultrasound, or hysterosalpingography (HSG). Exclusion criteria were refusal to undergo MRI, pregnancy during the study, or failure to attend scheduled imaging appointments. Seven patients were excluded: two became pregnant, two were noncompliant with MRI, and three were lost to follow-up, leaving 25 patients for final analysis. Imaging Protocols 3D/4D Ultrasonography : All ultrasonographic examinations were performed by an experienced gynecologist using a Voluson E6 ultrasound system (GE Healthcare, Milwaukee, WI, USA) equipped with a 5–9 MHz transvaginal volume probe. 3D/4D reconstruction of the uterine cavity and fundal contour was performed using multiplanar and rendered imaging modes. Magnetic Resonance Imaging (MRI): MRI was performed using a 3-Tesla system (Verio, Siemens, Erlangen, Germany) with a phased-array multichannel body coil. Standard T1- and T2-weighted sequences were obtained in axial, sagittal, and coronal planes. No contrast enhancement was used. The menstrual phase was not standardized among participants. Classification and Data Analysis Uterine anomalies were classified according to the American Society for Reproductive Medicine (ASRM, 1988) criteria. MRI scans were interpreted by radiologists who were not blinded to ultrasonographic findings. All data were analyzed using SPSS software (version 20.0, IBM Corp., Armonk, NY, USA). Concordance between 3D/4D ultrasonography and MRI was assessed using Cohen’s kappa (κ) statistic. Descriptive statistics were expressed as frequencies and percentages. A p -value < 0.05 was considered statistically significant. Results Patient Characteristics Of the 32 patients enrolled, 25 completed both imaging modalities and were included in the final analysis. Sixteen patients (50%) presented with infertility, three (9.3%) with a history of recurrent pregnancy loss, four (12.5%) with abnormal uterine bleeding, and seven (21.8%) were asymptomatic. Imaging Findings The distribution of uterine anomalies identified by 3D/4D ultrasonography and MRI is summarized in Table 1 . Diagnosis 3D/4D Ultrasonography (n = 25) MRI (n = 25) Surgically Confirmed (n = 13) Septate uterus 14 (56%) 5 (20%) 13 (100%) Arcuate uterus 4 (16%) 6 (24%) 0 Bicornuate uterus 3 (12%) 5 (20%) 0 Unicornuate uterus 1 (4%) 1 (4%) 0 Didelphys uterus 1 (4%) 0 (0%) 0 Rudimentary horn 2 (8%) 2 (8%) 0 No anomaly 0 (0%) 6 (24%) 0 3D/4D ultrasonography identified septate uterus as the most common anomaly (56%), whereas MRI reported a higher number of normal uterine findings (24%). Concordance Between Modalities Overall diagnostic concordance between 3D/4D ultrasonography and MRI was 40%, with a κ value of 0.266 ( p < 0.001), indicating low-to-moderate agreement. Discrepancies were observed in 13 of 25 patients (52%), primarily between the diagnosis of septate and arcuate uterus. Among the 13 patients who underwent surgery, 12 were confirmed to have septate uterus. 3D/4D ultrasonography correctly identified all 12 (positive predictive value, 92.3%), while MRI correctly diagnosed 4 (30.8%). Surgical Decision-Making Of the patients with discordant imaging results, surgical management was based on 3D/4D ultrasonography findings in 9 cases (69.2%) and on MRI findings in 4 cases (30.8%). The most significant diagnostic disagreement occurred in cases differentiating septate from arcuate uterus, particularly in women with infertility (n = 3, 60%) or recurrent pregnancy loss (n = 2, 40%). Discussion This prospective study compared the diagnostic performance and concordance between 3D/4D ultrasonography and MRI in evaluating Müllerian duct anomalies (MDAs). We observed a 40% overall agreement (κ = 0.266, p < 0.001) between the two imaging modalities, indicating low-to-moderate concordance. The greatest discrepancy occurred in differentiating septate from arcuate uteri, a distinction that holds critical clinical implications for fertility and surgical management [7, 18]. Our findings support recent literature suggesting that 3D/4D ultrasonography may rival, and in some cases outperform, MRI for MDA diagnosis [12]. Earlier studies favored MRI for its superior soft-tissue contrast and multiplanar imaging capabilities [8]. However, advances in 3D ultrasonographic technology, coupled with operator expertise, have narrowed this diagnostic gap [13]. Several studies have reported strong agreement between 3D ultrasound and surgical findings, with sensitivity and specificity approaching 100% [15]. Recently, 3D ultrasound has been reported to be concordant with MRI in 2 retrospective studies. Cekdemir et al. found 26/27 (96.3%) of the patients were diagnosed accurately with 3D ultrasound, while 24/27 (88.9%) of the patients were diagnosed with MRI [22]. And Qin et al. showed that 27/29 (93,1%) of the patients were accurately diagnosed with 3D ultrasound, while 24/29 (82,8%) were diagnosed with MRI [21]. In the present study, 3D/4D ultrasonography correctly identified 92.3% of surgically confirmed septate uteri, compared with 30.8% for MRI. This high predictive accuracy may be attributed to the operator’s dual role as both the gynecologist and surgeon, allowing real-time correlation between clinical findings, patient history, and imaging interpretation. This integration of anatomical and functional information may explain why 3D/4D ultrasonography guided the majority (69.2%) of surgical decisions in discordant cases. A prospective study on 7 patients who underwent surgery after only 3D ultrasound diagnosis provided 100% accuracy [23]. Radiologists may not encounter Müllerian anomalies as often as experienced gynecologists do. When detailed patient history and physical examination are not accurately forwarded to radiologists, this may lower MRI diagnostic accuracy. Moreover, 3D/4D ultrasound should be actively used for patients suspected of Müllerian anomalies. A gynecologist will gain more experience as they apply 3D ultrasound, and the accuracy rate may even increase. study and the literature show that surgeries can be performed with only 3D ultrasound diagnosis. It will lower costs and shorten waiting times. The most frequent diagnostic conflict occurred between septate and arcuate uterus. This difficulty is well recognized in the literature, as subtle differences in fundal indentation can lead to misclassification, particularly in MRI scans that lack dynamic uterine distension or patient-specific context [15]. Although arcuate uterus is generally considered a normal variant with favorable reproductive outcomes, some studies suggest that hysteroscopic correction may be beneficial in selected patients with recurrent pregnancy loss [9, 18, 19]. In our cohort, all three infertile patients with conflicting diagnoses had a history of reproductive failure, and two achieved pregnancy following surgical correction, supporting the potential benefit of 3D-guided decision-making. Despite the small sample size, our results align with previous reports highlighting the practicality and cost-effectiveness of 3D/4D ultrasonography in routine gynecologic practice [13, 15].It provides real-time, high-resolution imaging of the uterine cavity and fundal contour, is widely available, and avoids the expense and limited accessibility of MRI. For these reasons, 3D/4D ultrasonography may serve as a reliable first-line modality in the diagnostic workup of MDAs, with MRI reserved for complex or inconclusive cases. Limitations This study has several limitations. The most notable is the relatively small sample size (n = 25), which limits the generalizability of the findings. Not all diagnoses were confirmed by surgical or hysteroscopic evaluation, reducing the ability to assess true diagnostic accuracy. The fact that ultrasonographic examinations were performed and interpreted by the same gynecologist who later operated on some of the patients may have introduced observer bias in favor of 3D/4D ultrasonography. Additionally, the study did not standardize imaging timing according to the menstrual cycle, which can influence uterine morphology and diagnostic clarity. Future multicenter studies with larger cohorts and blinded, independent assessments are warranted to validate these findings. Conclusion Three-dimensional/four-dimensional ultrasonography demonstrated strong diagnostic performance and clinical utility in evaluating Müllerian duct anomalies. Although MRI remains the reference standard, 3D/4D ultrasonography offers substantial advantages in accessibility, cost, and real-time interpretation by the treating gynecologist. Given its high predictive value and influence on surgical decision-making, we recommend incorporating 3D/4D ultrasonography as an initial diagnostic tool—particularly when performed by experienced gynecologists familiar with both imaging and operative management. Larger randomized controlled studies are required to confirm these results further and to establish standardized imaging criteria for uterine anomaly classification. Declarations Ethical approval number: GU-516/2015 (Gazi University Ethical Committee) Clinical trial number: Not applicable Funding: This study was funded by Gazi University. References Raga F, Bauset C, Remohí J, Bonilla-Musoles F, Simón C, Pellicer A. Reproductive impact of congenital Müllerian anomalies. Hum Reprod. 1997;12(10):2277–81. American Fertility Society. The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, Müllerian anomalies and intrauterine adhesions. Fertil Steril. 1988;49(6):944–55. Reuter KL, Daly DC, Cohen SM. Septate versus bicornuate uteri: Errors in imaging diagnosis. Radiology. 1989;172(3):749–52. Randolph JR, Ying YK, Maier DB, Schmidt CL, Riddick DH, Randolph JF. Comparison of real-time ultrasonography, hysterosalpingography, and laparoscopy/hysteroscopy in the evaluation of uterine abnormalities and tubal patency. Fertil Steril. 1986;46(5):828–32. Caliskan E, Ozkan S, Cakiroglu Y, Sarisoy HT, Corakci A, Ozeren S. Diagnostic accuracy of real-time 3D sonography in the diagnosis of congenital Müllerian anomalies in high-risk patients with respect to the phase of the menstrual cycle. J Clin Ultrasound. 2010;38(3):123–7. Pellerito JS, McCarthy SM, Doyle MB, Glickman MG, DeCherney AH. Diagnosis of uterine anomalies: Relative accuracy of MR imaging, endovaginal sonography, and hysterosalpingography. Radiology. 1992;183(3):795–800. Troiano RN, McCarthy SM. Müllerian duct anomalies: Imaging and clinical issues. Radiology. 2004;233(1):19–34. Deutch TD, Abuhamad AZ. The role of three-dimensional ultrasonography and magnetic resonance imaging in the diagnosis of Müllerian duct anomalies: A review of the literature. J Ultrasound Med. 2008;27(3):413–23. Salim R, Woelfer B, Backos M, Regan L, Jurkovic D. Reproducibility of three-dimensional ultrasound diagnosis of congenital uterine anomalies. Ultrasound Obstet Gynecol . 2003;21(6):578–82. Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. Hum Reprod Update .2011;17(6):761–71. Ludwin A, Ludwin I, Neto MAC, Nastri CO, Bhagavath B, Lindheim SR, et al. Septate uterus according to ESHRE/ESGE, ASRM, and CUME definitions: association with infertility and miscarriage, cost, and warnings for women and healthcare systems. Ultrasound Obstet Gynecol. 2019;54(6):800–14. Moini A, Mohammadi S, Hosseini R, Eslami B, Ahmadi F. Accuracy of three-dimensional sonography for diagnosis and classification of congenital uterine anomalies. J Ultrasound Med. 2013;32(6):923–7. Ergenoglu AM, Sahin C, Simsek D, Yeniel AO, Akdemir A, Ulukus M, et al. Comparison of three-dimensional ultrasound and magnetic resonance imaging diagnosis in surgically proven Müllerian duct anomaly cases. Eur J Radiol. 2016;85(5):1025–30. Ghi T, Casadio P, Kuleva M, Perrone AM, Savelli L, Giunchi S, et al. Accuracy of three-dimensional ultrasound in diagnosis and classification of congenital uterine anomalies. Fertil Steril. 2009;92(2):808–13. Bermejo C, Martínez Ten P, Cantarero R, Diaz D, Pérez Pedregosa J, Barrón E, et al. Three-dimensional ultrasound in the diagnosis of Müllerian duct anomalies and concordance with magnetic resonance imaging. Ultrasound Obstet Gynecol. 2010;35(5):593–601. Buttram VC, Gibbons WE. Müllerian anomalies: A proposed classification (an analysis of 144 cases). Fertil Steril. 1979;32(1):40–6. Clifford K, Rai R, Watson H, Regan L. An informative protocol for the investigation of recurrent miscarriage: preliminary experience of 500 consecutive cases. Hum Reprod. 1994;9(7):1328–32. Tulandi T, Arronet GH, McInnes RA. Arcuate and bicornuate uterine anomalies and infertility. Fertil Steril. 1980;34(2):151–4. Valle RF, Ekpo GE. Hysteroscopic metroplasty for the septate uterus: review and meta-analysis. J Minim Invasive Gynecol. 2013;20(1):22–42. Rikken JFW, Verhorstert KWJ, Emanuel MH, Bongers MY, Spinder T, Kuchenbecker WKH, et al. Septum resection in women with a septate uterus: a cohort study. Hum Reprod. 2020;35(7):1578–88. Qin C, Lee P, Luo L. Comparison between 3D-Enhanced Conventional Pelvic Ultrasound and Magnetic Resonance Imaging in the Evaluation of Obstructive Müllerian Anomalies and Its Concordance with Surgical Diagnosis. J Pediatr Adolesc Gynecol. 2025;38(2):174–179. doi: 10.1016/j.jpag.2024.07.004. Epub 2024 Aug 3. PMID: 39098548. Cekdemir YE, Mutlu U, Acar D, Altay C, Secil M, Dogan OE. The accuracy of three-dimensional ultrasonography in the diagnosis of Müllerian duct anomalies and its concordance with magnetic resonance imaging. J Obstet Gynaecol. 2022;42(1):67–73. doi: 10.1080/01443615.2021.1877646. Epub 2021 May 3. PMID: 33938374. Kougioumtsidou A, Mikos T, Grimbizis GF, Karavida A, Theodoridis TD, Sotiriadis A, Tarlatzis BC, Athanasiadis AP. Three-dimensional ultrasound in the diagnosis and the classification of congenital uterine anomalies using the ESHRE/ESGE classification: a diagnostic accuracy study. Arch Gynecol Obstet. 2019;299(3):779–789. doi: 10.1007/s00404-019-05050-x . Epub 2019 Jan 19. PMID: 30661094. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8231443","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":560672328,"identity":"6c0debaf-25b0-4de0-8d50-b38cb2130bd1","order_by":0,"name":"Firat Buyuktaskin","email":"data:image/png;base64,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","orcid":"","institution":"Gazi University","correspondingAuthor":true,"prefix":"","firstName":"Firat","middleName":"","lastName":"Buyuktaskin","suffix":""},{"id":560672329,"identity":"4f8b2cb9-32de-48be-8750-ee90728b25e5","order_by":1,"name":"Gizem Işık","email":"","orcid":"","institution":"Gazi University","correspondingAuthor":false,"prefix":"","firstName":"Gizem","middleName":"","lastName":"Işık","suffix":""},{"id":560672330,"identity":"3807f21f-1f7c-4021-8fd4-5bb2abce750a","order_by":2,"name":"Serhan Can Iscan","email":"","orcid":"","institution":"Gazi University","correspondingAuthor":false,"prefix":"","firstName":"Serhan","middleName":"Can","lastName":"Iscan","suffix":""},{"id":560672333,"identity":"871abbb7-9993-4f6b-9583-8721743befef","order_by":3,"name":"ismail Güler","email":"","orcid":"","institution":"Gazi University","correspondingAuthor":false,"prefix":"","firstName":"ismail","middleName":"","lastName":"Güler","suffix":""},{"id":560672335,"identity":"2ac21e4e-e6ad-432b-a42a-4e85bf982344","order_by":4,"name":"Nesrin Erdogan","email":"","orcid":"","institution":"Gazi University","correspondingAuthor":false,"prefix":"","firstName":"Nesrin","middleName":"","lastName":"Erdogan","suffix":""},{"id":560672338,"identity":"603d1742-542f-4390-9fcb-20df6d53883a","order_by":5,"name":"Yusuf Oner","email":"","orcid":"","institution":"Gazi University","correspondingAuthor":false,"prefix":"","firstName":"Yusuf","middleName":"","lastName":"Oner","suffix":""},{"id":560672342,"identity":"7374559e-4971-48b8-a3df-a78f8cd3c5c7","order_by":6,"name":"Nuray Bozkurt","email":"","orcid":"","institution":"Gazi University","correspondingAuthor":false,"prefix":"","firstName":"Nuray","middleName":"","lastName":"Bozkurt","suffix":""}],"badges":[],"createdAt":"2025-11-28 14:53:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8231443/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8231443/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":98779536,"identity":"e18dc62a-4a25-4edd-8994-8088ea022721","added_by":"auto","created_at":"2025-12-22 12:30:26","extension":"jpg","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":107913,"visible":true,"origin":"","legend":"","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/0f4e975400fb3656cd69e6e1.jpg"},{"id":98757117,"identity":"cac72d56-9a61-4086-b5e1-c39572b30510","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":19306,"visible":true,"origin":"","legend":"","description":"","filename":"3DmriAGO.docx","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/7f6d1903ce9f330c54635322.docx"},{"id":98757119,"identity":"9fdc920f-8499-4520-a24d-b4a3c3cd01f8","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"jpg","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":82180,"visible":true,"origin":"","legend":"","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/054bac623b61155a5c35e085.jpg"},{"id":98778145,"identity":"dfde76fb-6d49-4d1d-a00a-a91ffe52bb3c","added_by":"auto","created_at":"2025-12-22 12:28:56","extension":"jpg","order_by":3,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":132090,"visible":true,"origin":"","legend":"","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/9eeaa97ab5ba53814578416c.jpg"},{"id":98757126,"identity":"399951e3-b72a-496d-9fb4-b81685cf0cd6","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"json","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":8621,"visible":true,"origin":"","legend":"","description":"","filename":"33b32c5d51184ecdbf8bf551e2b0528f.json","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/3712845ddbf0c99cc748937f.json"},{"id":98757114,"identity":"f05c624b-0387-433c-9ffe-a7c5e44cbfbc","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"xml","order_by":5,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":61865,"visible":true,"origin":"","legend":"","description":"","filename":"33b32c5d51184ecdbf8bf551e2b0528f1enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/60f3fd678c45e5bfbd3a4fec.xml"},{"id":98779554,"identity":"b6844459-d65c-4c22-9dff-1bd76043788d","added_by":"auto","created_at":"2025-12-22 12:30:27","extension":"jpg","order_by":6,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":107913,"visible":true,"origin":"","legend":"","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/93ca512f24cf992c1f5c6f65.jpg"},{"id":98779512,"identity":"198252a1-cde8-41f1-a32b-53bf3cff3416","added_by":"auto","created_at":"2025-12-22 12:30:26","extension":"jpg","order_by":7,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":82180,"visible":true,"origin":"","legend":"","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/fd6c240a4cb1651248afd628.jpg"},{"id":98757124,"identity":"d0e482d2-5b76-4dea-872d-f0acd3f75f84","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"jpg","order_by":8,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":132090,"visible":true,"origin":"","legend":"","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/2c50f7efbbb7f10316a3f697.jpg"},{"id":98757123,"identity":"b90ce6a8-0e62-4ab0-aadd-8d5bfa673c69","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"png","order_by":9,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":107624,"visible":true,"origin":"","legend":"","description":"","filename":"Online1.png","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/4695d6b32a98b222ed174f15.png"},{"id":98778614,"identity":"b9ae3dcf-d260-4241-9f5f-dc2d8004d3ff","added_by":"auto","created_at":"2025-12-22 12:29:28","extension":"png","order_by":10,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":49890,"visible":true,"origin":"","legend":"","description":"","filename":"Online2.png","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/562895f9b2c2951736eee890.png"},{"id":98757127,"identity":"d38e9fd1-67aa-4887-8654-317888f939e1","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"png","order_by":11,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":129055,"visible":true,"origin":"","legend":"","description":"","filename":"Online3.png","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/65b173c0ff7e372725e81e14.png"},{"id":98757129,"identity":"83beb667-368d-4f3e-925d-2afa718bc648","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"xml","order_by":12,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":56903,"visible":true,"origin":"","legend":"","description":"","filename":"33b32c5d51184ecdbf8bf551e2b0528f1structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/9727100b9a185fe2c1cb26f7.xml"},{"id":98757128,"identity":"d1a0218f-17fd-4d1c-b2d2-a77771b0770d","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"html","order_by":13,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":69975,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/fc86922cf03544a803b70ad1.html"},{"id":98757112,"identity":"e298723f-8eac-4135-8661-273a51d5c634","added_by":"auto","created_at":"2025-12-22 09:36:47","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":107913,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/aec4677cbf9a989cc5c62c68.jpg"},{"id":98779765,"identity":"f5ceed94-6919-4fbb-9978-b0a66b2f3cfd","added_by":"auto","created_at":"2025-12-22 12:30:43","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":82180,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/5729a5063d3f0f713cb9c527.jpg"},{"id":98779438,"identity":"ff345a46-6f3e-4ebd-938c-c8fbb7938ee4","added_by":"auto","created_at":"2025-12-22 12:30:21","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":195598,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version\u003c/p\u003e","description":"","filename":"3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/d7fcec29d78947bfb35ca9af.jpg"},{"id":101345292,"identity":"14cb93d8-923f-4738-b102-4dc435c3857b","added_by":"auto","created_at":"2026-01-28 17:00:04","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":943332,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8231443/v1/e93a3b7e-0f9b-49fb-863d-2e7b9cf25de2.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Diagnostic Accuracy of 3D/4D Transvaginal Ultrasound Compared With MRI for Müllerian Uterine Anomalies: A Prospective Study Using Hysteroscopic Confirmation for Septate Uterus","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCongenital uterine malformations arise from incomplete fusion, resorption, or development of the M\u0026uuml;llerian ducts. The prevalence of M\u0026uuml;llerian duct anomalies (MDAs) in the general population is approximately 4%, increasing to 6\u0026ndash;7% among women with infertility or recurrent pregnancy loss. Accurate diagnosis is essential because MDAs are associated with adverse reproductive outcomes, including infertility, miscarriage, and preterm delivery [1].\u003c/p\u003e \u003cp\u003eHistorically, hysterosalpingography (HSG) was the primary diagnostic tool, but its diagnostic accuracy is limited to about 55% and it exposes patients to radiation and potential infection [2]. While combined hysteroscopy and laparoscopy remain the gold standard for definitive diagnosis, their invasive nature and cost limit widespread use [7]. Therefore, non-invasive imaging modalities have gained importance [3].\u003c/p\u003e \u003cp\u003eMagnetic resonance imaging (MRI) has been shown to provide excellent anatomical detail and high diagnostic accuracy\u0026mdash;reported sensitivity and specificity up to 100% in some studies [6,8]. However, its limited availability, cost, and requirement for radiologic interpretation restrict its routine use. In contrast, three-dimensional (3D) and four-dimensional (4D) ultrasonography are widely accessible, cost-effective, and allow real-time evaluation of uterine morphology, particularly the fundal contour, which is critical for differentiating septate from bicornuate uteri [5].\u003c/p\u003e \u003cp\u003ePrevious studies have demonstrated high reproducibility and good correlation between 3D ultrasonography and surgical findings, suggesting that it may serve as a reliable, non-invasive alternative to MRI in selected patients [1, 5, 13, 21, 22]. The present study aims to compare the diagnostic concordance of 3D/4D ultrasonography and MRI in detecting M\u0026uuml;llerian duct anomalies and to assess their respective influences on clinical decision-making regarding surgery.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design and Participants\u003c/h2\u003e \u003cp\u003eThis was a prospective observational study conducted at the Department of Obstetrics and Gynecology, Gazi University School of Medicine (Ankara, Turkey), between November 2016 and November 2017. The study was approved by the Gazi University Ethics Committee (Approval No: GU-516/2015), and written informed consent was obtained from all participants.\u003c/p\u003e \u003cp\u003eThirty-two women who presented to either the infertility or general gynecology outpatient clinics with suspected M\u0026uuml;llerian duct anomalies (MDAs) were enrolled. Indications for imaging included infertility, recurrent pregnancy loss, abnormal uterine bleeding, or incidental findings on two-dimensional (2D) ultrasonography.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eInclusion and Exclusion Criteria\u003c/h3\u003e\n\u003cp\u003eInclusion criteria were reproductive-aged women with suspected uterine anomalies on clinical examination, 2D ultrasound, or hysterosalpingography (HSG).\u003c/p\u003e \u003cp\u003e Exclusion criteria were refusal to undergo MRI, pregnancy during the study, or failure to attend scheduled imaging appointments. Seven patients were excluded: two became pregnant, two were noncompliant with MRI, and three were lost to follow-up, leaving 25 patients for final analysis.\u003c/p\u003e\n\u003ch3\u003eImaging Protocols\u003c/h3\u003e\n\u003cp\u003e \u003cb\u003e3D/4D Ultrasonography\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eAll ultrasonographic examinations were performed by an experienced gynecologist using a Voluson E6 ultrasound system (GE Healthcare, Milwaukee, WI, USA) equipped with a 5\u0026ndash;9 MHz transvaginal volume probe. 3D/4D reconstruction of the uterine cavity and fundal contour was performed using multiplanar and rendered imaging modes.\u003c/p\u003e\n\u003ch3\u003eMagnetic Resonance Imaging (MRI):\u003c/h3\u003e\n\u003cp\u003eMRI was performed using a 3-Tesla system (Verio, Siemens, Erlangen, Germany) with a phased-array multichannel body coil. Standard T1- and T2-weighted sequences were obtained in axial, sagittal, and coronal planes. No contrast enhancement was used. The menstrual phase was not standardized among participants.\u003c/p\u003e\n\u003ch3\u003eClassification and Data Analysis\u003c/h3\u003e\n\u003cp\u003eUterine anomalies were classified according to the American Society for Reproductive Medicine (ASRM, 1988) criteria. MRI scans were interpreted by radiologists who were not blinded to ultrasonographic findings.\u003c/p\u003e \u003cp\u003eAll data were analyzed using SPSS software (version 20.0, IBM Corp., Armonk, NY, USA). Concordance between 3D/4D ultrasonography and MRI was assessed using Cohen\u0026rsquo;s kappa (κ) statistic. Descriptive statistics were expressed as frequencies and percentages. A \u003cem\u003ep\u003c/em\u003e-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003ePatient Characteristics\u003c/h2\u003e \u003cp\u003eOf the 32 patients enrolled, 25 completed both imaging modalities and were included in the final analysis. Sixteen patients (50%) presented with infertility, three (9.3%) with a history of recurrent pregnancy loss, four (12.5%) with abnormal uterine bleeding, and seven (21.8%) were asymptomatic.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eImaging Findings\u003c/h3\u003e\n\u003cp\u003eThe distribution of uterine anomalies identified by 3D/4D ultrasonography and MRI is summarized in \u003cb\u003eTable\u0026nbsp;1\u003c/b\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiagnosis\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3D/4D Ultrasonography (n\u0026thinsp;=\u0026thinsp;25)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMRI (n\u0026thinsp;=\u0026thinsp;25)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSurgically Confirmed (n\u0026thinsp;=\u0026thinsp;13)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSeptate uterus\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (56%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13 (100%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eArcuate uterus\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (16%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (24%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBicornuate uterus\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (12%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (20%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnicornuate uterus\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDidelphys uterus\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRudimentary horn\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo anomaly\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (24%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e3D/4D ultrasonography identified septate uterus as the most common anomaly (56%), whereas MRI reported a higher number of normal uterine findings (24%).\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eConcordance Between Modalities\u003c/h2\u003e \u003cp\u003eOverall diagnostic concordance between 3D/4D ultrasonography and MRI was 40%, with a κ value of 0.266 (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001), indicating low-to-moderate agreement. Discrepancies were observed in 13 of 25 patients (52%), primarily between the diagnosis of septate and arcuate uterus.\u003c/p\u003e \u003cp\u003eAmong the 13 patients who underwent surgery, 12 were confirmed to have septate uterus. 3D/4D ultrasonography correctly identified all 12 (positive predictive value, 92.3%), while MRI correctly diagnosed 4 (30.8%).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eSurgical Decision-Making\u003c/h2\u003e \u003cp\u003eOf the patients with discordant imaging results, surgical management was based on 3D/4D ultrasonography findings in 9 cases (69.2%) and on MRI findings in 4 cases (30.8%). The most significant diagnostic disagreement occurred in cases differentiating septate from arcuate uterus, particularly in women with infertility (n\u0026thinsp;=\u0026thinsp;3, 60%) or recurrent pregnancy loss (n\u0026thinsp;=\u0026thinsp;2, 40%).\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis prospective study compared the diagnostic performance and concordance between 3D/4D ultrasonography and MRI in evaluating M\u0026uuml;llerian duct anomalies (MDAs). We observed a 40% overall agreement (κ\u0026thinsp;=\u0026thinsp;0.266, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001) between the two imaging modalities, indicating low-to-moderate concordance. The greatest discrepancy occurred in differentiating septate from arcuate uteri, a distinction that holds critical clinical implications for fertility and surgical management [7, 18].\u003c/p\u003e \u003cp\u003eOur findings support recent literature suggesting that 3D/4D ultrasonography may rival, and in some cases outperform, MRI for MDA diagnosis [12]. Earlier studies favored MRI for its superior soft-tissue contrast and multiplanar imaging capabilities [8]. However, advances in 3D ultrasonographic technology, coupled with operator expertise, have narrowed this diagnostic gap [13]. Several studies have reported strong agreement between 3D ultrasound and surgical findings, with sensitivity and specificity approaching 100% [15]. Recently, 3D ultrasound has been reported to be concordant with MRI in 2 retrospective studies. Cekdemir et al. found 26/27 (96.3%) of the patients were diagnosed accurately with 3D ultrasound, while 24/27 (88.9%) of the patients were diagnosed with MRI [22]. And Qin et al. showed that 27/29 (93,1%) of the patients were accurately diagnosed with 3D ultrasound, while 24/29 (82,8%) were diagnosed with MRI [21].\u003c/p\u003e \u003cp\u003eIn the present study, 3D/4D ultrasonography correctly identified 92.3% of surgically confirmed septate uteri, compared with 30.8% for MRI. This high predictive accuracy may be attributed to the operator\u0026rsquo;s dual role as both the gynecologist and surgeon, allowing real-time correlation between clinical findings, patient history, and imaging interpretation. This integration of anatomical and functional information may explain why 3D/4D ultrasonography guided the majority (69.2%) of surgical decisions in discordant cases. A prospective study on 7 patients who underwent surgery after only 3D ultrasound diagnosis provided 100% accuracy [23]. Radiologists may not encounter M\u0026uuml;llerian anomalies as often as experienced gynecologists do. When detailed patient history and physical examination are not accurately forwarded to radiologists, this may lower MRI diagnostic accuracy. Moreover, 3D/4D ultrasound should be actively used for patients suspected of M\u0026uuml;llerian anomalies. A gynecologist will gain more experience as they apply 3D ultrasound, and the accuracy rate may even increase. study and the literature show that surgeries can be performed with only 3D ultrasound diagnosis. It will lower costs and shorten waiting times.\u003c/p\u003e \u003cp\u003eThe most frequent diagnostic conflict occurred between septate and arcuate uterus. This difficulty is well recognized in the literature, as subtle differences in fundal indentation can lead to misclassification, particularly in MRI scans that lack dynamic uterine distension or patient-specific context [15]. Although arcuate uterus is generally considered a normal variant with favorable reproductive outcomes, some studies suggest that hysteroscopic correction may be beneficial in selected patients with recurrent pregnancy loss [9, 18, 19]. In our cohort, all three infertile patients with conflicting diagnoses had a history of reproductive failure, and two achieved pregnancy following surgical correction, supporting the potential benefit of 3D-guided decision-making.\u003c/p\u003e \u003cp\u003eDespite the small sample size, our results align with previous reports highlighting the practicality and cost-effectiveness of 3D/4D ultrasonography in routine gynecologic practice [13, 15].It provides real-time, high-resolution imaging of the uterine cavity and fundal contour, is widely available, and avoids the expense and limited accessibility of MRI. For these reasons, 3D/4D ultrasonography may serve as a reliable first-line modality in the diagnostic workup of MDAs, with MRI reserved for complex or inconclusive cases.\u003c/p\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eLimitations\u003c/h2\u003e \u003cp\u003eThis study has several limitations. The most notable is the relatively small sample size (n\u0026thinsp;=\u0026thinsp;25), which limits the generalizability of the findings. Not all diagnoses were confirmed by surgical or hysteroscopic evaluation, reducing the ability to assess true diagnostic accuracy. The fact that ultrasonographic examinations were performed and interpreted by the same gynecologist who later operated on some of the patients may have introduced observer bias in favor of 3D/4D ultrasonography. Additionally, the study did not standardize imaging timing according to the menstrual cycle, which can influence uterine morphology and diagnostic clarity. Future multicenter studies with larger cohorts and blinded, independent assessments are warranted to validate these findings.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThree-dimensional/four-dimensional ultrasonography demonstrated strong diagnostic performance and clinical utility in evaluating M\u0026uuml;llerian duct anomalies. Although MRI remains the reference standard, 3D/4D ultrasonography offers substantial advantages in accessibility, cost, and real-time interpretation by the treating gynecologist. Given its high predictive value and influence on surgical decision-making, we recommend incorporating 3D/4D ultrasonography as an initial diagnostic tool\u0026mdash;particularly when performed by experienced gynecologists familiar with both imaging and operative management. Larger randomized controlled studies are required to confirm these results further and to establish standardized imaging criteria for uterine anomaly classification.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical approval number:\u0026nbsp;\u003c/strong\u003eGU-516/2015 (Gazi University Ethical Committee)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number:\u0026nbsp;\u003c/strong\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was funded by Gazi University.\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eRaga F, Bauset C, Remoh\u0026iacute; J, Bonilla-Musoles F, Sim\u0026oacute;n C, Pellicer A. Reproductive impact of congenital M\u0026uuml;llerian anomalies. \u003cem\u003eHum Reprod.\u003c/em\u003e 1997;12(10):2277\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmerican Fertility Society. The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, M\u0026uuml;llerian anomalies and intrauterine adhesions. \u003cem\u003eFertil Steril.\u003c/em\u003e 1988;49(6):944\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eReuter KL, Daly DC, Cohen SM. Septate versus bicornuate uteri: Errors in imaging diagnosis. \u003cem\u003eRadiology.\u003c/em\u003e1989;172(3):749\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRandolph JR, Ying YK, Maier DB, Schmidt CL, Riddick DH, Randolph JF. Comparison of real-time ultrasonography, hysterosalpingography, and laparoscopy/hysteroscopy in the evaluation of uterine abnormalities and tubal patency. \u003cem\u003eFertil Steril.\u003c/em\u003e 1986;46(5):828\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCaliskan E, Ozkan S, Cakiroglu Y, Sarisoy HT, Corakci A, Ozeren S. Diagnostic accuracy of real-time 3D sonography in the diagnosis of congenital M\u0026uuml;llerian anomalies in high-risk patients with respect to the phase of the menstrual cycle. \u003cem\u003eJ Clin Ultrasound.\u003c/em\u003e 2010;38(3):123\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePellerito JS, McCarthy SM, Doyle MB, Glickman MG, DeCherney AH. Diagnosis of uterine anomalies: Relative accuracy of MR imaging, endovaginal sonography, and hysterosalpingography. \u003cem\u003eRadiology.\u003c/em\u003e 1992;183(3):795\u0026ndash;800.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTroiano RN, McCarthy SM. M\u0026uuml;llerian duct anomalies: Imaging and clinical issues. \u003cem\u003eRadiology.\u003c/em\u003e 2004;233(1):19\u0026ndash;34.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeutch TD, Abuhamad AZ. The role of three-dimensional ultrasonography and magnetic resonance imaging in the diagnosis of M\u0026uuml;llerian duct anomalies: A review of the literature. \u003cem\u003eJ Ultrasound Med.\u003c/em\u003e 2008;27(3):413\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSalim R, Woelfer B, Backos M, Regan L, Jurkovic D. Reproducibility of three-dimensional ultrasound diagnosis of congenital uterine anomalies. \u003cem\u003eUltrasound Obstet Gynecol\u003c/em\u003e. 2003;21(6):578\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. The prevalence of congenital uterine anomalies in unselected and high-risk populations: a systematic review. \u003cem\u003eHum Reprod Update\u003c/em\u003e.2011;17(6):761\u0026ndash;71.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLudwin A, Ludwin I, Neto MAC, Nastri CO, Bhagavath B, Lindheim SR, et al. Septate uterus according to ESHRE/ESGE, ASRM, and CUME definitions: association with infertility and miscarriage, cost, and warnings for women and healthcare systems. \u003cem\u003eUltrasound Obstet Gynecol.\u003c/em\u003e 2019;54(6):800\u0026ndash;14.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoini A, Mohammadi S, Hosseini R, Eslami B, Ahmadi F. Accuracy of three-dimensional sonography for diagnosis and classification of congenital uterine anomalies. \u003cem\u003eJ Ultrasound Med.\u003c/em\u003e 2013;32(6):923\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eErgenoglu AM, Sahin C, Simsek D, Yeniel AO, Akdemir A, Ulukus M, et al. Comparison of three-dimensional ultrasound and magnetic resonance imaging diagnosis in surgically proven M\u0026uuml;llerian duct anomaly cases. \u003cem\u003eEur J Radiol.\u003c/em\u003e 2016;85(5):1025\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGhi T, Casadio P, Kuleva M, Perrone AM, Savelli L, Giunchi S, et al. Accuracy of three-dimensional ultrasound in diagnosis and classification of congenital uterine anomalies. \u003cem\u003eFertil Steril.\u003c/em\u003e 2009;92(2):808\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBermejo C, Mart\u0026iacute;nez Ten P, Cantarero R, Diaz D, P\u0026eacute;rez Pedregosa J, Barr\u0026oacute;n E, et al. Three-dimensional ultrasound in the diagnosis of M\u0026uuml;llerian duct anomalies and concordance with magnetic resonance imaging. \u003cem\u003eUltrasound Obstet Gynecol.\u003c/em\u003e 2010;35(5):593\u0026ndash;601.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eButtram VC, Gibbons WE. M\u0026uuml;llerian anomalies: A proposed classification (an analysis of 144 cases). \u003cem\u003eFertil Steril.\u003c/em\u003e1979;32(1):40\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eClifford K, Rai R, Watson H, Regan L. An informative protocol for the investigation of recurrent miscarriage: preliminary experience of 500 consecutive cases. \u003cem\u003eHum Reprod.\u003c/em\u003e 1994;9(7):1328\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTulandi T, Arronet GH, McInnes RA. Arcuate and bicornuate uterine anomalies and infertility. \u003cem\u003eFertil Steril.\u003c/em\u003e1980;34(2):151\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eValle RF, Ekpo GE. Hysteroscopic metroplasty for the septate uterus: review and meta-analysis. \u003cem\u003eJ Minim Invasive Gynecol.\u003c/em\u003e 2013;20(1):22\u0026ndash;42.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRikken JFW, Verhorstert KWJ, Emanuel MH, Bongers MY, Spinder T, Kuchenbecker WKH, et al. Septum resection in women with a septate uterus: a cohort study. \u003cem\u003eHum Reprod.\u003c/em\u003e 2020;35(7):1578\u0026ndash;88.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQin C, Lee P, Luo L. Comparison between 3D-Enhanced Conventional Pelvic Ultrasound and Magnetic Resonance Imaging in the Evaluation of Obstructive M\u0026uuml;llerian Anomalies and Its Concordance with Surgical Diagnosis. J Pediatr Adolesc Gynecol. 2025;38(2):174\u0026ndash;179. doi: 10.1016/j.jpag.2024.07.004. Epub 2024 Aug 3. PMID: 39098548.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCekdemir YE, Mutlu U, Acar D, Altay C, Secil M, Dogan OE. The accuracy of three-dimensional ultrasonography in the diagnosis of M\u0026uuml;llerian duct anomalies and its concordance with magnetic resonance imaging. J Obstet Gynaecol. 2022;42(1):67\u0026ndash;73. doi: 10.1080/01443615.2021.1877646. Epub 2021 May 3. PMID: 33938374.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKougioumtsidou A, Mikos T, Grimbizis GF, Karavida A, Theodoridis TD, Sotiriadis A, Tarlatzis BC, Athanasiadis AP. Three-dimensional ultrasound in the diagnosis and the classification of congenital uterine anomalies using the ESHRE/ESGE classification: a diagnostic accuracy study. Arch Gynecol Obstet. 2019;299(3):779\u0026ndash;789. doi: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/s00404-019-05050-x\u003c/span\u003e\u003cspan address=\"10.1007/s00404-019-05050-x\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Epub 2019 Jan 19. PMID: 30661094.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-8231443/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8231443/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective:\u003c/strong\u003e\u003cbr\u003e\n To compare the diagnostic accuracy and concordance of three-dimensional/four-dimensional (3D/4D) ultrasonography and magnetic resonance imaging (MRI) in detecting Müllerian duct anomalies (MDAs) and to evaluate their impact on surgical decision-making.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003cbr\u003e\n This prospective observational study included 32 patients who presented to the infertility or gynecology outpatient clinics at Gazi University Hospital between November 2016 and November 2017. All patients underwent both 3D/4D transvaginal ultrasonography (Voluson E6, GE Healthcare) and pelvic MRI (3T Verio, Siemens). Diagnoses were classified according to the American Society of Reproductive Medicine (ASRM, 1988) criteria. Concordance between the two imaging modalities was evaluated using the kappa (κ) statistic.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003cbr\u003e\n Of the 32 enrolled patients, 25 completed both imaging studies. Overall concordance between 3D/4D ultrasonography and MRI was 40% (κ = 0.266, \u003cem\u003ep\u003c/em\u003e \u0026lt; 0.001), indicating low-to-moderate agreement. The most common diagnosis with 3D/4D ultrasonography was septate uterus (56%), compared with 20% by MRI. Among 13 patients who underwent surgery, 12 were correctly diagnosed as having septate uterus by 3D/4D ultrasonography (positive predictive value, 92.3%), while MRI correctly identified four (30.8%). Surgical decisions were based on 3D/4D ultrasonography in 69.2% of discordant cases and on MRI in 30.8%.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003cbr\u003e\n Although MRI remains the reference standard for evaluating MDAs, 3D/4D ultrasonography demonstrated strong clinical value in guiding surgical management and offered advantages of accessibility, real-time assessment, and lower cost. We recommend that 3D/4D ultrasonography be performed by the operating gynecologist prior to surgical planning. Larger randomized studies are warranted to validate these findings.\u003c/p\u003e","manuscriptTitle":"Diagnostic Accuracy of 3D/4D Transvaginal Ultrasound Compared With MRI for Müllerian Uterine Anomalies: A Prospective Study Using Hysteroscopic Confirmation for Septate Uterus","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-22 09:36:41","doi":"10.21203/rs.3.rs-8231443/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5db1fab7-8504-4317-a9f2-be89fbfa3703","owner":[],"postedDate":"December 22nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-01-28T16:58:28+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-22 09:36:41","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8231443","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8231443","identity":"rs-8231443","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}