I. Ludwin

Two- and Three-Dimensional Ultrasonography and Sonohysterography versus Hysteroscopy With Laparoscopy in the Differential Diagnosis of Septate, Bicornuate, and Arcuate Uteri

STUDY OBJECTIVE To estimate the diagnostic accuracy and to compare the diagnostic value of 3-dimensional sonohysterography (3D-SIS), 3-dimensional transvaginal ultrasonography (3D-TVS), 2-dimensional sonohysterography (2D-SIS), and 2-dimensional transvaginal ultrasonography (2D-TVS) (initial and expert diagnosis) in the differential diagnosis of septate, bicornuate, and arcuate uteri. DESIGN Prospective clinical study (Canadian Task Force II-2). SETTING University hospital and private hospital and clinic. PATIENTS A total of 117 women with a history of recurrent abortions or infertility and a 2D-TVS initial diagnosis of a septate, bicornuate, or arcuate uterus. INTERVENTIONS Expert 2D-TVS, 3D-TVS, 2D-SIS, and 3D-SIS performed by experienced examiners and hysteroscopy with laparoscopy to establish the final diagnosis. MEASUREMENTS AND MAIN RESULTS Hysteroscopy performed in conjunction with laparoscopy (HL) detected 23 arcuate, 60 septate, 22 bicornuate, and 12 normal uteri. 3D-SIS showed perfect diagnostic accuracy (100.0%) in general detection of uterine abnormalities, compared with initial 2D-TVS (77.8%), expert 2D-TVS (90.6%), 2D-SIS (94.0%), and 3D-TVS (97.4%). In the overall diagnosis of uterine anomalies, all of the diagnostic methods had statistically significantly better diagnostic value than initial 2D-TVS (p < .001), whereas 3D-SIS was the only method that was better than expert 2D-TVS (p < .001). CONCLUSIONS Although 3D-SIS was identical to HL, with the highest accuracy, there was no significant difference in diagnostic value between 3D-TVS with 2D-SIS and 3D-SIS or between expert 2D-TVS and 3D-TVS with 2D-SIS. The high diagnostic value of these ultrasonographic tools questions the need for endoscopy in the differential diagnosis of the most common congenital uterine anomalies.

Comparison of the ESHRE–ESGE and ASRM classifications of Müllerian duct anomalies in everyday practice

STUDY QUESTION Does the European Society of Human Reproduction and Embryology–European Society for Gynaecological Endoscopy (ESHRE–ESGE) classification of female genital tract malformations significantly increase the frequency of septate uterus diagnosis relative to the American Society for Reproductive Medicine (ASRM) classification? SUMMARY ANSWER Use of the ESHRE–ESGE classification, compared with the ASRM classification, significantly increased the frequency of septate uterus recognition. WHAT IS KNOWN ALREADY The ESHRE–ESGE criteria were supposed to eliminate the subjective diagnoses of septate uterus by the ASRM criteria and replace the complementary absolute morphometric criteria. However, the clinical value of the ESHRE–ESGE classification in daily practice is difficult to appreciate. The application of the ESHRE–ESGE criteria has resulted in a significantly increased recognition of residual septum after hysteroscopic metroplasty, with a possible risk of overdiagnosis of septate uterus and problems for its management. STUDY DESIGN, SIZE, AND DURATION A prospective observational study was performed with 261 women consecutively enrolled between June and September 2013. PARTICIPANTS/MATERIALS, SETTING, AND METHODS Non-pregnant women of reproductive age presented for evaluation to a private medical center. A gynecological examination and 3D ultrasonography were performed to assess the anatomy of the uterus, cervix and vagina. Congenital anomalies were diagnosed using the ASRM classification with additional morphometric criteria as well as with the ESHRE–ESGE classification. We compared the frequency and concordance of diagnoses of septate uterus and all congenital malformations of the uterus according to both classifications. The morphological characteristics of septate uterus recognized by both criteria were compared. MAIN RESULTS AND ROLE OF CHANCE Of the 261 patients enrolled in this study, septate uterus was diagnosed in 44 (16.9%) and 16 (6.1%) patients using the ESGE–ESHRE and ASRM criteria, respectively [relative risk (RR)ESHRE–ESGE:ASRM 2.74; 95% confidence interval (CI), 1.6–4.72; P < 0.01]. At least one congenital anomaly were diagnosed in 58 (22.2%) and 43 (16.5%) patients using the ESHRE–ESGE and ASRM classifications (RRESHRE–ESGE:ASRM, 1.35; 95% CI, 0.95–1.92, P = 0.1), respectively. The two criteria had moderate strength of agreement in the diagnosis of septate uterus (κ = 0.45, P < 0.01). There was good agreement in differentiation between anomaly and norm between the two assessment criteria (κ = 0.79, P < 0.01). The percentages of all congenital malformations and results of the differentiation between the anomaly and norm were obtained after excluding the confounding original ESHRE–ESGE criterion of dysmorphic uterus (internal indentation <50% uterine wall thickness). The morphology of septa identified by the ESHRE–ESGE [length of internal fundal indentation (mm): median 10.7; lower–upper quartile, 8.1–20] significantly differed (P < 0.01) from that identified by the ASRM criteria [length of internal fundal indentation (mm): median, 21.1; lower–upper quartile, 18.8–33.1]. Internal fundal indentation in 16 out of 44 (36.4%) cases was <1 cm in the septate uterus by ESHRE–ESGE and met the criteria for normal uterus by ASRM. LIMITATIONS AND REASONS FOR CAUTION The study participants were women who visited a diagnostic and treatment center specialized in uterine congenital malformations for a medical assessment, not from the general public. WIDER IMPLICATIONS OF THE FINDINGS Septate uterus diagnosis by ESHRE–ESGE was quantitatively dominated by morphological states corresponding to arcuate uterus or cases that were not diagnosed as congenital malformations by ASRM. Relative overdiagnosis of septate uterus by ESHRE–ESGE in these cases may lead to unnecessary overtreatment without the expected benefits. The ESHRE–ESGE classification criteria should be redefined due to confusions in the methodology. Until the criteria are revised, septate uterus should not be diagnosed using this classification system and it should not be used as an eligibility criterion for hysteroscopic metroplasty. STUDY FUNDING/COMPETING INTEREST(S) This work was supported by Jagiellonian University (grant no. K/ZDS/003821). The authors have no competing interests to declare.

Diagnostic accuracy of three-dimensional sonohysterography compared with office hysteroscopy and its interrater/intrarater agreement in uterine cavity assessment after hysteroscopic metroplasty.

OBJECTIVE To compare the diagnostic accuracy of three-dimensional sonohysterography (3D-SIS) and office hysteroscopy in uterine cavity assessment after hysteroscopic metroplasty (HM) and determine the interrater/intrarater agreement for 3D-SIS. DESIGN Prospective observational study. SETTING University hospital, private hospital, and clinic. PATIENT(S) One hundred forty-one women undergoing HM for septate uterus with a history of miscarriage and/or infertility. INTERVENTION(S) 3D-SIS and office hysteroscopy at 6-8 weeks after HM. MAIN OUTCOME MEASURE(S) Shape of the uterine cavity, length of the fundal notch (≥1 or <1 cm), and the presence of intrauterine adhesions were assessed, and the interrater/intrarater agreement of 3D-SIS was evaluated in 30 randomly selected patients. RESULT(S) Uterine abnormalities were detected with the use of hysteroscopy in 18 (12.8%) of 141 women. 3D-SIS was highly accurate (97.2%), sensitive (97%), and specific (100%), with a positive predictive value of 100% and a negative predictive value of 85%. The diagnostic values of hysteroscopy and 3D-SIS were not significantly different (McNemar test). 3D-SIS showed substantial interrater/intrarater agreement regarding overall uterine cavity evaluation (κ = 0.79 and 0.78, respectively). CONCLUSION(S) 3D-SIS demonstrated substantial interrater/intrarater agreement for the postoperative evaluation of the uterine cavity, being as diagnostically accurate as hysteroscopy. The use of second-look hysteroscopy may be limited to cases that require reoperation.

Reply: Are the ESHRE/ESGE criteria of female genital anomalies for diagnosis of septate uterus appropriate?

Sir, We are following with interest the European Society of Human Reproduction and Embryology/European Society for Gynaecological Endoscopy (ESHRE/ESGE) initiative to create a new classification of female genital tract congenital anomalies (Grimbizis et al. 2013). We applied the European criteria routinely using three-dimensional (3D) ultrasonography, while simultaneously classifying our patients based on the American Society for Reproductive Medicine (ASRM) criteria (Buttram et al. 1988), complemented by additional common morphometric criteria used to differentiate septate, bicornuate and arcuate uteri (Bermejo et al. 2010, Ludwin et al. 2013). We encountered three problems: (i) practical adaptation of the ESHRE–ESGE classification criteria for septate uterus diagnosis, (ii) an increased frequency of septate uterus diagnoses and all uterine congenital anomalies according to the ESHRE–ESGE compared with the ASRM classification (because a septate uterus was diagnosed in cases where uteri fulfilled previous morphometric criteria for arcuate and in some cases normal uteri) and (iii) potentially important clinical implications of the new classification. We believe that application of ESHRE–ESGE criteria may cause difficulties because (i) the thickness of the uterine wall as the reference value for the septate uterus diagnosis may vary in different regions of the uterus. Thus, it is important to determine where and how it should be measured and (ii) the original definition of septate uterus is an abnormally shaped uterine cavity. The ratio of myometrial thickness to the size of the internal fundal indentation may not reflect the actual anatomical relationships in the uterus and lead to false diagnoses (Fig. 1). Another drawback of the relative criteria is that they are not compatible with endoscopic techniques since myometrial thickness cannot be assessed. The application of the ESHRE/ESGE criteria may have serious clinical implications. The diagnosis of uterine septum on the basis of relative ESHRE/ESGE criteria is not supported by retrospective results and prospective studies of corrective surgery. This applies to eligibility for hysteroscopic metroplasty of patients with recurrent miscarriages who have a small internal fundal indentation; the proposed treatment may not improve obstetric results. A more serious concern is that prophylactic metroplasty may be performed in these cases prior to assist reproductive technology procedures. Additionally, the new classification may affect the assessment of anatomical results of corrective surgery, which could result in frequent repeat procedures, possibly without any significant effect on reproductive performance. This might affect the decision to re-operate in cases whereprevious retrospective studies suggested no indication for complementary metroplasty (residual septum

Transrectal Ultrasound-Guided Hysteroscopic Myomectomy of Submucosal Myomas With a Varying Degree of Myometrial Penetration

STUDY OBJECTIVE To predict the 1-step complete resection rate after transrectal ultrasound-guided hysteroscopic myomectomy and to determine the usefulness of intraoperative transrectal ultrasonography (TRUS) in monitoring hysteroscopic electroresection of submucosal myomas. DESIGN Prospective cohort study (Canadian Task Force classification II-1). SETTING University hospital. PATIENTS One hundred twenty women with symptomatic (abnormal uterine bleeding or reproductive disorder), single, submucosal myomas underwent hysteroscopic electroresection. Groups 1 and 2 were monitored, respectively, with or without TRUS. Anatomical inclusion criteria were myoma ≤5 cm and myometrial free margin ≥3 mm above the myoma. INTERVENTIONS Myomas were evaluated preoperatively via sonohysterograpy and were graded according to the guidelines outlined by the European Society of Hysteroscopy (ESH), including size and myometrial free margin, and according to the STEPW (size, topography, extension, penetration, and lateral wall) classification. On the basis of sonographic findings, patients with myomas >3 cm received gonadotropin-releasing hormone therapy for 1 to 3 months. Hysteroscopic myomectomy was performed with or without TRUS guidance. At 4 to 8 weeks after the initial procedure, postoperative transvaginal ultrasonography, sonohysterography, or second-look hysteroscopy was performed. MEASUREMENTS AND MAIN RESULTS In the TRUS group, a significantly higher percentage of 1-step complete resections was observed than in the group without TRUS (91% vs 73%) (p = .02). This was associated with a statistically significant difference in the subgroups of myomas that were deeply penetrating into the myometrium (89% vs 55%) (p < .01). One-way logistic analysis of data for all treated patients indicated the use of TRUS, as well as the ESH and STEPW classifications, as significant factors influencing the 1-step complete resection. At multivariable logistic regression analysis, use of TRUS (odds ratio [OR], 2.74; p < .001), myomas graded 0 or 1 according to ESH (OR, 3.55; p < .001), and size <3 cm (OR, 2.35; p < .05) were significantly associated with 1-step complete resection (area under the curve, 0.80; p < .001). In the TRUS group there were two significant predictors: size <3 cm (OR = 5.21; p < .05) and myometrial free margin <5 mm (OR, 0.18; p < .05). CONCLUSION Intraoperative use of TRUS during hysteroscopic myomectomy increases the chance of complete 1-step removal of submucosal myomas that deeply penetrate the myometrium.

Uterine cavity imaging, volume estimation and quantification of degree of deformity using automatic volume calculation: description of technique

Figure 1 Uterine cavity volume estimation using SonoHysteroAVC technique (sonohysterography and automatic volume calculation software, SonoAVC general). (a) Multiplanar view and resulting uterine cavity volume estimation. (b) Three different balloon catheter positions on HDLive and SonoAVC general. (c) Incorporation of volume of balloon catheter into total uterine cavity volume. (d) Uterine cavity volume estimation, with and without balloon catheter inside uterine cavity.

Reliability of the European Society of Human Reproduction and Embryology/European Society for Gynaecological Endoscopy and American Society for Reproductive Medicine classification systems for congenital uterine anomalies detected using three-dimensional ultrasonography

OBJECTIVE To estimate the inter-rater/intrarater reliability of the European Society of Human Reproduction and Embryology/European Society for Gynaecological Endoscopy (ESHRE-ESGE) classification of congenital uterine malformations and to compare the results obtained with the reliability of the American Society for Reproductive Medicine (ASRM) classification supplemented with additional morphometric criteria. DESIGN Reliability/agreement study. SETTING Private clinic. PATIENT(S) Uterine malformations (n = 50 patients, consecutively included) and normal uterus (n = 62 women, randomly selected) constituted the study. These were classified based on real-time three-dimensional ultrasound single volume transvaginal (or transrectal in the case of virgins, 4 cases) ultrasonography findings, which were assessed by an expert rater based on the ESHRE-ESGE criteria. The samples were obtained from women of reproductive age. INTERVENTION(S) Unprocessed three-dimensional datasets were independently evaluated offline by two experienced, blinded raters using both classification systems. MAIN OUTCOME MEASURE(S) The κ-values and proportions of agreement. RESULT(S) Standardized interpretation indicated that the ESHRE-ESGE system has substantial/good or almost perfect/very good reliability (κ >0.60 and >0.80), but the interpretation of the clinically relevant cutoffs of κ-values showed insufficient reliability for clinical use (κ < 0.90), especially in the diagnosis of septate uterus. The ASRM system had sufficient reliability (κ > 0.95). CONCLUSION(S) The low reliability of the ESHRE-ESGE system may lead to a lack of consensus about the management of common uterine malformations and biased research interpretations. The use of the ASRM classification, supplemented with simple morphometric criteria, may be preferred if their sufficient reliability can be confirmed real-time in a large sample size.

Accuracy of hysterosalpingo-foam sonography in comparison to hysterosalpingo-contrast sonography with air/saline and to laparoscopy with dye

Study question What is the diagnostic accuracy of 2D/3D hysterosalpingo-foam sonography (HyFoSy) and 2D/3D-high-definition flow Doppler (HDF)-HyFoSy in comparison to laparoscopy with dye chromotubation (as the reference method) and 2D air/saline-enhanced hysterosalpingo-contrast sonography (HyCoSy) (as the initial index test)? Summary answer 2D/3D-HDF-HyFoSy had the best diagnostic accuracy and was the only method that did not significantly differ from the reference method, while both 2D/3D-HyFoSy and 2D/3D-HDF-HyFoSy had significantly higher accuracy than 2D-air/saline-HyCoSy. What is known already Previous studies on X-ray hysterosalpingography and laparoscopy and dye as the reference standard have undermined the impact of older commercial contrast agents on the accuracy of ultrasound tubal patency tests. Recently, HyFoSy was reported to have very high accuracy in a small pilot study in comparison to laparoscopy and dye, and had a very high positive predictive value (PPV) for medical tubal occlusion. A new Doppler sonographic technique, known as HDF imaging with better axial resolution, fewer blooming artifacts and higher sensitivity than color and power Doppler imaging, has been introduced. Study design, size, duration A prospective observational study was performed on 132 women (259 Fallopian tubes) consecutively enrolled between 2013 and 2015. Participants/materials, setting, methods This study included infertile women of reproductive age who previously had not been examined for tubal patency and who presented for the evaluation to the university hospital, private hospital and clinic at which this study was conducted. 2D-Air/saline-HyCoSy, 2D/3D-HyFoSy and 2D/3D-HDF-HyFoSy and laparoscopy were performed independently by experienced readers. During HyFoSy, the 3D mode was used for standardization of pelvic scanning and observations of contrast flow without diagnosis after volume acquisition. Sensitivity, specificity, negative and positive predictive value (NPV and PPV), negative and positive-likelihood ratio (LR- and LR+) and 95% CI were calculated. McNemars test and relative predictive values (a comparison of NPV and PPV) were used to compare all the index tests. Main results and the role of chance 2D-Air/saline-HyCoSy, 2D/3D-HyFoSy and 2D/3D-HDF-HyFoSy indicated that 46 (17.8%), 27 (10.4%) and 24 (9.2%) of the 259 tubes were occluded, respectively; additionally, inconclusive results were obtained for 8 (3%), 5 (1.9%) and 3 (1.2%) tubes, respectively. The reference method revealed 18 (6.9%) occluded Fallopian tubes. 2D-Air/saline-HyCoSy had a high NPV (99.5%) that was similar to that of 2D/3D-HyFoSy (99%) and 2D/3D-HDF-HyFoSy (99.6%) (P > 0.05), but had a very low PPV (30.4%). The use of 2D/3D-HyFoSy, especially 2D/3D-HDF-HyFoSy, which had a significantly higher PPV (48% and 71%, P < 0.05 and P < 0.01; respectively), resulted in fewer false positive and inconclusive findings than the use of 2D-air/saline-HyCoSy. The LR- and LR+ was 0.14 and 14.8, respectively, for 2D/3D-HyFoSy, 0.06 and 32.1, respectively, for 2D/3D-HDF-HyFoSy, and 0.08 and 6.9, respectively, for 2D-air/saline-HyCoSy. The number of inconclusive or positive results per patient was significantly fewer with 2D/3D-HyFoSy (odds ratio, OR = 0.5, CI = 0.3-0.95, P < 0.05) and 2D/3D-HDF-HyFoSy (OR = 0.4, 95% CI = 0.2-0.8, P < 0.01) than with 2D-air/saline-HyCoSy. Limitations, reasons for caution An unselected infertile population with a low prevalence of tubal occlusion is suitable for estimating the diagnostic accuracy of imaging tests only as a screening tool. Wider implications of the findings These findings can be used to establish a diagnostic strategy with high accuracy but minimum invasiveness and limited use of contrast agents and sophisticated technology. 2D-Air/saline-HyCoSy, which has a high NPV, is suitable as an initial test and basic screening method, but 2D/3D-HDF-HyFoSy, which has a significantly higher PPV, can be used as a standard to verify any questionable or positive results obtained with 2D HyCoSy. This strategy may signficantly reduce the need for laparoscopy as a reference standard. Study funding/competing interest(s) There was no external funding for this study, and the authors have no conflicts of interest to declare. Trial registration number N/A.

Robert's uterus: modern imaging techniques and ultrasound‐guided hysteroscopic treatment without laparoscopy or laparotomy

Roberts uterus is a unique malformation, described as a septate uterus with a non‐communicating hemicavity, consisting of a blind uterine horn usually with unilateral hematometra, a contralateral unicornuate uterine cavity and a normally shaped external uterine fundus. The main symptom in affected young women is pelvic pain that becomes intensified near menses. We describe the case of a 22‐year‐old woman who was referred for diagnostic assessment and treatment of a congenital uterine anomaly. We used three‐dimensional sonohysterography with volume‐contrast imaging, HDLive rendering mode and automatic volume calculation (SonoHysteroAVC) for the diagnosis, surgical planning and postoperative evaluation. These imaging techniques provided a complete understanding of the internal and external uterine structures, enabling us to perform a minimally invasive hysteroscopic metroplasty, guided by transrectal ultrasound, and therefore avoiding the need for laparotomy/laparoscopy. The outcome of treatment was considered satisfactory; menstruation ceased to be painful and, after two hysteroscopic procedures, the communicating 0.3‐cm3 hemicavity was visualized as a 3.6‐cm3 normalized uterine cavity using the same imaging techniques. The findings of this case report raise questions about the embryological origin of Roberts uterus, the suitability of current classification systems, and the role of more invasive approaches (laparoscopy/laparotomy) and surgical procedures (horn resection/endometrectomy) that do not aim to improve uterine cavity shape and volume in women with this condition. Copyright

Congenital Uterine Malformation by Experts (CUME): better criteria for distinguishing between normal/arcuate and septate uterus?

To assess the level of agreement between experts in distinguishing between septate and normal/arcuate uterus using their subjective judgment when reviewing the coronal view of the uterus from three‐dimensional ultrasound. Another aim was to determine the interobserver reliability and diagnostic test accuracy of three measurements suggested by recent guidelines, using as reference standard the decision made most often by experts (Congenital Uterine Malformation by Experts (CUME)).