Verification Bias Correction in Endometrial Abnormalities in Infertile Women Referred to Royan Institute Using Statistical Methods.

Background: Verification bias is a common bias in the diagnostic accuracy of diagnostic tests and occurs when a number of individuals do not perform the gold standard test. In this study, we review the correcting methods of verification bias. Methods: In a cross-sectional study in 2020, 567 infertile women who were referred to Royan Research Institute were evaluated. The ultrasound is the performed test and the gold standard are hysteroscopy for some, and pathology for other abnormalities. For correcting verification bias conventional, Begg and Greens, Zhou, and logistic regression methods were used. Results: In the gold standard hysteroscopy test, the sensitivity (SEN) and specificity (SPEC) obtained in conventional, Begg and Greens, Zhou, and logistics Regression methods were (50%, 90.3%), (48%, 96%), (22%, 77%), (50%, 90%), and (72.8, 77) respectively. Furthermore, the area under the curve (AUC) index and kappa statistics were calculated as 70.2%, and 43.6% respectively. In the pathology gold standard test, the SEN and SPEC for the conventional methods, Begg and Greens, Zhou and logistics regression were (67.7%, 86.7%), (66%, 88%), (29%, 70%), (66.9%, 87.6%), and (73%, 83.9%) respectively. Also, the AUC index and kappa statistics were 77%, and 55% respectively. Conclusion: In the study on endometrial abnormalities in infertile women, assuming that the missing data mechanism is random, the amount of bias in calculating SEN and SPEC is very low in the diagnostic tests calculated before and after correction, using Begg and Greens and logistic regression method. But Zhou's method gives rather large biased estimates.

Unilateral Kidney Agenesis and other Kidney Anomalies in Infertile Men with Congenital Bilateral Absence of Vas deferens: A Cross-Sectional Study.

BACKGROUND: We aim to determine the prevalence of renal anomalies in patients with congenital vas deferens agenesis referred for infertility assessment.
Materials and Methods: This cross-sectional study was carried out on eligible infertile men from 2016 to 2019. Infertile men who were suspected of obstructive azoospermia were referred to the Ultrasound ward and they were examined by abdominal ultrasound for detecting the genital and kidney anomalies. An informed consent form was filled out by patients. Data was entered into SPSS software 21. Patients were divided into two groups in terms of congenital bilateral absence of vas deferens (CBAVD) or congenital unilateral absence of the vas deferens (CUAVD). Using the Chi-square test kidney anomalies between groups were compared. The P<0.05 was considered significant.
Results: The mean age of participants was 33.05 ± 6.35. The frequency of CBAVD was 66 and the frequency of left side VD and right side VD were 23 and 21, respectively. The percentage of other comorbidities was calculated. Out of 110 cases, 12 (11%) men had coexistence of vas deferens and kidney agenesis. Other studies are in agreement with our findings. Although the percentage of CBAVD and CUAVD were 9.1% and 1.8% respectively, the difference was not significant (P=0.07).
Conclusion: Considering the fact that kidney agenesis is a remarkable congenital anomaly that coexists with the majority of vas deferens agenesis cases and could not be detected by routine laboratory tests or transrectal ultrasound
examination, it should be ruled out with transabdominal ultrasound examination after detection of vas deferens agenesis.

Does amniotic fluid sludge result in preterm labor in pregnancies after assisted reproduction technology? A nested Case - Control study.

OBJECTIVE: to investigate the relationship between the Amniotic fluid Sludge exposure during pregnancy and the Preterm Labor (PTL) in pregnant women who had undergone Assisted Reproductive Technology procedures (ART) in Royan institute. MATERIALS AND METHODS: It was a nested case-control study that was conducted on 110 eligible pregnant women who had undergone IVF procedure in Royan institute, Tehran, Iran. The final sample size was 63 subjects with Amniotic fluid Sludge and 67 subjects with normal Amniotic fluid. Delivery before 37 of gestation was considered as PTL.The study was approved by the ethics committee of the Royan institute and the written consent form was filled by participants. Data was entered to the SPSS (version 21, SPSS, Inc.). The baseline characteristics of the participants were described as absolute (n) and relative (%) frequencies for the covariates. Man Whitney and T-Test were used to compare the mean of covariates and the P-value lower than 0.05 was considered significant. The prevalence of the PTL was compared between two groups. RESULTS: The mean Gestational Age at delivery in case and control group were 36.46 ± 3.45 and 38.03 ± 1.61, respectively which was significant (p = .01). The prevalence of PTL in case and control group were 23.8% and 10.4% respectively which was significant (p = .04). The percentage of cases with cervical length less than 30 (mm) in case and control group were 28.6% and 10.4%, respectively (p = .008) and the percentage of cerclage in case and control group were 33.3% and 7.5% respectively, (p = .00) which were significant statistically. CONCLUSION: The amniotic fluid sludge has a direct effect on the cervical length of pregnancies after ART. In such cases, PTB will be probable in the presence of sludge in spite of preventive treatments such as cerclage.

Outcome of isolated fetal choroid plexus cyst detected in prenatal sonography among infertile patients referred to Royan Institute: A 3-year study.

BACKGROUND: Several studies have assessed the correlation of fetal choroid plexus cyst (CPC) and the risk of congenital anomalies, but few ones have discussed isolated CPC (with no other abnormal sonographic finding). OBJECTIVE: The aim of this study was to determine the outcome of isolated fetal choroid plexus cyst and to specify its clinical significance. MATERIALS AND METHODS: This cross sectional study was carried out at Royan Institute in Tehran, Iran, between April 2009 and December 2012. All prenatal sonographies in this period of time were assessed using a computerized database and fetuses who had isolated CPC were recruited in the study. Sonography reports, mother serum screening test results, fetal echocardiography and amniocentesis were evaluated until birth. A follow-up phone call was made to all individuals to learn about the neonatal outcomes. RESULTS: Overall, 6240 prenatal sonographies were performed in this setting during this period. Isolated CPC was detected in 64 fetuses. The results of double test (N=30), triple test (N=5) and fetal echocardiography (N =24) were normal. Quadruple test result showed 3 abnormal out of 29 cases that all had normal karyotypes. Four samples were dropped out due to premature rupture of membranes (N=3) and intrauterine fetal death (N=1). It was found that the outcomes of all remaining fetuses (N=60) were normal and no anomaly ones were seen until birth. CONCLUSION: Isolated CPC is a benign regressive condition with no clinical significance.

Comparison of two dimensional and live three dimensional ultrasounds for the diagnosis of septated uterus.

BACKGROUND: Traditionally, septate uterus was diagnosed with invasive method like hysterosalpingography and hysteroscopy. Nowadays transvaginal ultrasonography was reported to be a sensitive tool for detection of septate uterus too. OBJECTIVE: The objective of the present study was to evaluate the application of two dimensional ultrasound (2-DUS) and real time three dimensional ultrasound (3-DUS) in differentiating various type of septated uterus. Hysteroscopy confirmation was assigned as the gold standard. MATERIALS AND METHODS: This retrospective study was performed among 215 infertile women with suspected septate uterus from October 2008 to July 2012. An inclusion criterion was septated uterus based on HSG or experiencing abortion, preterm labor, or recurrent IVF failure. Fusion anomalies were excluded from the study (unicornuate, bicornuate and didelphys anomalies). The results of 3D and 2D sonographies were compared, while they were confirmed by hysteroscopy result in detection of septated uterus. Kappa index for agreement between 2DUS and hysteroscopy, as well as 3-DUS and hysteroscopy in detection of septate uterus was carried out. By receiver operating characteristic (ROC) curve, cut off points for predicting the kind of anomalies were proposed. RESULTS: The women were evaluated by 2-DUS (n=89) and (II) 3-DUS (n=126). All women underwent hysteroscopy, following 2-DUS and 3-DUS at the same or subsequent cycle. The results of kappa (K) index were 0.575 and 0.291 for 3-DUS and hysteroscopy, as well as 2-DUS and hysteroscopy, respectively. Also, the cutoff points were 27% for arcuate and subseptate, and 35% for differentiating septate and subseptate. CONCLUSION: Real time 3-DUS has better ability for visualization both uterine cavity and the fundal uterine, so it has higher agreement in detection of septate uterus than 2-DUS.

Diagnostic accuracy of transvaginal sonography in the detection of uterine abnormalities in infertile women.

BACKGROUND: Accurate diagnosis of uterine abnormalities has become a core part of the fertility work-up. A variety of modalities can be used for the diagnosis of uterine abnormalities. OBJECTIVES: This study was designed to assess the diagnostic accuracy of transvaginal ultrasonography (TVS) in uterine pathologies of infertile patients using hysteroscopy as the gold standard. PATIENTS AND METHODS: This was a cross-sectional study carried out in the Department of Reproductive Imaging at Royan Institute from October 2007 to October 2008. In this study, the medical documents of 719 infertile women who were investigated with transvaginal ultrasound (TVS) and then hysteroscopy were reviewed. All women underwent hysteroscopy in the same cycle time after TVS. Seventy-six out of 719 patients were excluded from the study and 643 patients were studied. TVS was performed in the follicular phase after cessation of bleeding. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated for TVS. Hysteroscopy served as the gold standard. RESULTS: The overall sensitivity, specificity, positive and negative predictive values for TVS in the diagnosis of uterine abnormality was 79%, 82%, 84% and 71%, respectively. The sensitivity and PPV of TVS in detection of polyp were 88.3% and 81.6%, respectively. These indices were 89.2% and 92.5%, respectively for fibroma, 67% and 98.3%, respectively for subseptated uterus and 90.9% and 100%, respectively for septated uterus. Adhesion and unicornuated uterus have the lowest sensitivity with a sensitivity of 35% and PPV of 57.1%. CONCLUSION: TVS is a cost-effective and non-invasive method for diagnosis of intrauterine lesions such as polyps, submucosal fibroids and septum. It is a valuable adjunctive to hysteroscopy with high accuracy for identification and characterization of intrauterine abnormalities. This may lead to a more precise surgery plan and performance.