Method and reliability of measuring midurethral area and echogenicity, and changes during and after pregnancy

INTRODUCTION AND HYPOTHESIS: Internal closure of the urethral sphincter is one of the mechanisms in maintaining continence. Little is known about changes in the urethral sphincter during pregnancy. We designed this study to develop a reliable method to measure the area and mean echogenicity of the midurethra during and after pregnancy and to assess changes over time. METHODS: Two observers independently segmented the urethra as follows: in the sagittal plane, the urethra was positioned vertically, the marker was placed in the middle section of the lumen of the urethra, and eight tomographic US images of 2.5 -mm slices were obtained. The central image was selected, and area and mean echogenicity were calculated automatically. Intra- and interobserver reliability were determined by intraclass correlation coefficients (ICC) and their 95% confidence intervals (CI). Two hundred and eighty women underwent TPUS at 12 weeks and 36 weeks of gestation and 6 months postpartum, and 3D/4D transperineal ultrasound (TPUS) images of 40 pregnant nulliparous women were used for the reliability study. Paired t tests were used to assess changes in echogenicity and area. RESULTS: The ICC for measuring the area was substantial, at 0.77 and for measuring mean echogenicity was almost perfect, at 0.86. In the total study group (n = 280), midurethral area and mean echogenicity were significantly lower 6 months after delivery compared with 12 and 36 weeks of gestation. CONCLUSIONS: Our protocol for measuring area and mean echogenicity of the midurethra is reliable. This study indicates that structural changes in the midurethraoccur during pregnancy

Endometrial scratching in women undergoing IVF/ICSI : an individual participant data meta-analysis

Funding No specific funding was sought for this project. The sponsor of this project is the University Medical Center Utrecht (UMC Utrecht), Utrecht, the Netherlands. The sponsor was not involved in the study design, data interpretation, or writing of the manuscript.Peer reviewedPublisher PD

Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH)

STUDY QUESTION: Does endometnal scratching in women with one failed IVF/ICSI treatment affect the chance of a live birth of the subsequent fresh IVF/ICSI cycle? SUMMARY ANSWER: In this study, 4.6% more live births were observed in the scratch group, with a likely certainty range between -0.7% and +9.9%. WHAT IS KNOWN ALREADY: Since the first suggestion that endometrial scratching might improve embryo implantation during IVF/ICSI, many clinical trials have been conducted. However, due to limitations in sample size and study quality, it remains unclear whether endometrial scratching improves IVF/ICSI outcomes. STUDY DESIGN, SIZE, DURATION: The SCRaTCH trial was a non-blinded randomised controlled trial in women with one unsuccessful IVF/ICSI cycle and assessed whether a single endometrial scratch using an endometrial biopsy catheter would lead to a higher live birth rate after the subsequent IVF/ICSI treatment compared to no scratch. The study took place in 8 academic and 24 general hospitals. Participants were randomised between January 2016 and July 2018 by a web-based randomisation programme. Secondary outcomes included cumulative 12-month ongoing pregnancy leading to live birth rate. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with one previous failed IVF/ICSI treatment and planning a second fresh IVF/ICSI treatment were eligible. In total, 933 participants out of 1065 eligibles were included (participation rate 88%). MAIN RESULTS AND THE ROLE OF CHANCE: After the fresh transfer, 4.6% more live births were observed in the scratch compared to control group (110/465 versus 88/461, respectively, risk ratio (RR) 1.24 [95% CI 0.96-1.59]). These data are consistent with a true difference of between - 0.7% and 9.9% (95% CI), indicating that while the largest proportion of the 95% CI is positive, scratching could have no or even a small negative effect. Biochemical pregnancy loss and miscarriage rate did not differ between the two groups: in the scratch group 27/153 biochemical pregnancy losses and 14/126 miscarriages occurred, while this was 19/130 and 17/11 I for the control group (RR 1.21 (95% CI 0.71-2.07) and RR 0.73 (95% CI 0.38-1.40), respectively). After 12 months of follow-up, 5.1% more live births were observed in the scratch group (202/467 versus 178/466), of which the true difference most likely lies between -1.2% and +11.4% (95% CI). LIMITATIONS, REASONS FOR CAUTION: This study was not blinded. Knowledge of allocation may have been an incentive for participants allocated to the scratch group to continue treatment in situations where they may otherwise have cancelled or stopped. In addition, this study was powered to detect a difference in live birth rate of 9%. WIDER IMPLICATIONS OF THE FINDINGS: The results of this study are an incentive for further assessment of the efficacy and clinical implications of endometrial scratching. If a true effect exists, it may be smaller than previously anticipated or may be limited to specific groups of women undergoing IVF/ICSI. Studying this will require larger sample sizes, which will be provided by the ongoing international individual participant data-analysis (PROSPERO CRD42017079120). At present, endometrial scratching should not be performed outside of clinical trials

Endometrial scratching in women with one failed IVF/ICSI cycle-outcomes of a randomised controlled trial (SCRaTCH)

STUDY QUESTION: Does endometrial scratching in women with one failed IVF/ICSI treatment affect the chance of a live birth of the subsequent fresh IVF/ICSI cycle? SUMMARY ANSWER: In this study, 4.6% more live births were observed in the scratch group, with a likely certainty range between -0.7% and +9.9%. WHAT IS KNOWN ALREADY: Since the first suggestion that endometrial scratching might improve embryo implantation during IVF/ICSI, many clinical trials have been conducted. However, due to limitations in sample size and study quality, it remains unclear whether endometrial scratching improves IVF/ICSI outcomes. STUDY DESIGN, SIZE, DURATION: The SCRaTCH trial was a non-blinded randomised controlled trial in women with one unsuccessful IVF/ICSI cycle and assessed whether a single endometrial scratch using an endometrial biopsy catheter would lead to a higher live birth rate after the subsequent IVF/ICSI treatment compared to no scratch. The study took place in 8 academic and 24 general hospitals. Participants were randomised between January 2016 and July 2018 by a web-based randomisation programme. Secondary outcomes included cumulative 12-month ongoing pregnancy leading to live birth rate. PARTICIPANTS/MATERIALS, SETTING, METHODS: Women with one previous failed IVF/ICSI treatment and planning a second fresh IVF/ICSI treatment were eligible. In total, 933 participants out of 1065 eligibles were included (participation rate 88%). MAIN RESULTS AND THE ROLE OF CHANCE: After the fresh transfer, 4.6% more live births were observed in the scratch compared to control group (110/465 versus 88/461, respectively, risk ratio (RR) 1.24 [95% CI 0.96-1.59]). These data are consistent with a true difference of between -0.7% and +9.9% (95% CI), indicating that while the largest proportion of the 95% CI is positive, scratchin

Endometrial scratching in IVF/ICSI treatment: Clinical effectiveness and prognostic factors

Test-tube treatment (IVF/ICSI) is frequently being used to treat infertility worldwide, but unfortunately only 35% of the transferred embryos implant. Endometrial scratching, a procedure in which a biopsy is taken from the lining of the uterus, has been suggested to improve implantation. This thesis describes a review, randomized clinical trial and individual participant data analysis (IPD) that study whether endometrial scratching improves embryo implantation – and thus live birth –, if it is cost-effective, if it is more or less effective in subgroups of women, and if scratching affects pregnancy complications or a low birthweight. The randomized controlled trial showed that a single scratch in women with one failed IVF/ICSI cycle probably increases the chance of a live birth with approximately 4.6%-point (confidence interval -0.7% - +9.9%). This effect remained after 12 months (5.1%-point increase, confidence interval -1.2% - +11.4%). Cost-effectiveness depends on the exact effect and the costs for a scratch. Based on the Dutch estimations, IVF/ICSI with scratching will cost approximately €17,500.- for each additional live birth, which is below the threshold of €20,000.-. We could not identify subgroups of women that benefit more or less from scratching, and we could not find an association with pregnancy complications or a low birthweight. The timing of scratching in the menstrual cycle could be essential to the effect on live birth, and could therefore, along with the underlying biological mechanism of action, be a focus for future research

Association between levator hiatal dimensions on ultrasound during first pregnancy and mode of delivery

Objectives To determine the association between levator hiatal dimensions, measured using transperineal ultrasound, in women during their first pregnancy and the subsequent mode of delivery, stratified by the indication for intervention. Methods In this prospective observational study, 280 nulliparous women with a singleton pregnancy were invited for transperineal ultrasound examination at 12 and 36 weeks' gestation. Their levator hiatal dimensions were measured at rest, on pelvic floor muscle contraction and on Valsalva maneuver. The subsequent mode of delivery was classified into five categories: spontaneous vaginal delivery, instrumental vaginal delivery owing to fetal distress, instrumental vaginal delivery owing to failure to progress, Cesarean section owing to fetal distress and Cesarean section owing to failure to progress. Levator hiatal dimensions according to mode of delivery were compared by analysis of variance and Tukey's post-hoc test. Since multiple comparison tests were performed, the statistical significance level was corrected using the Bonferroni method. Results Of the 252 women included, those who delivered by Cesarean section because of failure to progress had a significantly smaller levator hiatal transverse diameter on pelvic floor contraction at 12 weeks' gestation than did women who had a spontaneous vaginal delivery (Tukey's post-hoc test, P <0.001). There was also a trend towards a smaller hiatal area on pelvic floor contraction at 12 weeks' gestation in women who delivered by Cesarean section because of failure to progress compared to women who had a spontaneous vaginal delivery (Tukey's post-hoc test, P = 0.005). In women who had an instrumental vaginal delivery because of failure to progress there was a trend towards a smaller levator hiatal anteroposterior diameter on pelvic floor contraction at 36 weeks' gestation compared with women who had a spontaneous vaginal delivery (Tukey's post-hoc test, P = 0.033). Conclusions Smaller levator hiatal dimensions on pelvic floor contraction during first pregnancy are associated with a subsequent instrumental vaginal delivery or a Cesarean section owing to failure to progress. Copyright (C) 2014 ISUOG. Published by John Wiley & Sons Ltd