ObjectiveTo evaluate the effectiveness of a laparoscopic niche resection on niche‐related symptoms and/or fertility‐related problems, ultrasound findings and quality of life.DesignProspective cohort study.SettingUniversity hospital.PopulationWomen with a large niche (residual myometrium <3 mm) and complaints of either postmenstrual spotting, dysmenorrhoea, intrauterine fluid accumulation and/or difficulties with embryo transfer due to distorted anatomy.MethodsWomen filled out questionnaires and a validated menstrual score chart at baseline and 6 months after the laparoscopic niche resection. At baseline and between 3 and 6 months follow up niches were evaluated by transvaginal ultrasound.Main outcome measuresThe primary outcome was reduction of the main problem 6 months after the intervention. Secondary outcomes were complications, menstrual characteristics, dysmenorrhoea, niche measurements, intrauterine fluid, surgical outcomes, satisfaction and quality of life.ResultsIn all, 101 women underwent a laparoscopic niche resection. In 80 women (79.2%) the main problem was improved or resolved. Postmenstrual spotting was significantly reduced by 7 days at 6 months follow up compared with baseline. Dysmenorrhoea and discomfort related to spotting was also significantly reduced. The residual myometrium was increased significantly at follow up. The intrauterine fluid was resolved in 86.9% of the women with intrauterine fluid at baseline; 83.3% of women were (very) satisfied. The physical component of quality of life increased, the mental component did not change.ConclusionsA laparoscopic niche resection reduced postmenstrual spotting, discomfort due to spotting, dysmenorrhoea and the presence of intrauterine fluid in the majority of women and increased the residual myometrium.Tweetable abstractLaparoscopic niche resection reduces niche‐related problems and enlarges the residual myometrium.

STUDY QUESTION Does a previous Caesarean section affect reproductive outcomes, including live birth, in women after IVF or ICSI? SUMMARY ANSWER A previous Caesarean section impairs live birth rates after IVF or ICSI compared to a previous vaginal delivery. WHAT IS KNOWN ALREADY Rates of Caesarean sections are rising worldwide. Late sequelae of a Caesarean section related to a niche (Caesarean scar defect) include gynaecological symptoms and obstetric complications. A systematic review reported a lower pregnancy rate after a previous Caesarean section (RR 0.91 CI 0.87–0.95) compared to a previous vaginal delivery. So far, studies have been unable to causally differentiate between problems with fertilisation, and the transportation or implantation of an embryo. Studying an IVF population allows us to identify the effect of a previous Caesarean section on the implantation of embryos in relation to a previous vaginal delivery. STUDY DESIGN, SIZE, DURATION We retrospectively studied the live birth rate in women who had an IVF or ICSI treatment at the IVF Centre, Amsterdam UMC, location VUmc, Amsterdam, the Netherlands, between 2006 and 2016 with one previous delivery. In total, 1317 women were included, of whom 334 had a previous caesarean section and 983 had previously delivered vaginally. PARTICIPANTS/MATERIALS, SETTING, METHODS All secondary infertile women, with only one previous delivery either by caesarean section or vaginal delivery, were included. If applicable, only the first fresh embryo transfer was included in the analyses. Patients who did not intend to undergo embryo transfer were excluded. The primary outcome was live birth. Multivariate logistic regression analyses were used with adjustment for possible confounders ((i) age; (ii) pre-pregnancy BMI; (iii) pre-pregnancy smoking; (iv) previous fertility treatment; (v) indication for current fertility treatment: (a) tubal, (b) male factor and (c) endometriosis; (vi) embryo quality; and (vii) endometrial thickness), if applicable. Analysis was by intention to treat (ITT). MAIN RESULTS AND THE ROLE OF CHANCE Baseline characteristics of both groups were comparable. Live birth rates were significantly lower in women with a previous caesarean section than in women with a previous vaginal delivery, 15.9% (51/320) versus 23.3% (219/941) (OR 0.63 95% CI 0.45–0.87) in the ITT analyses. The rates were also lower for ongoing pregnancy (20.1 versus 28.1% (OR 0.64 95% CI 0.48–0.87)), clinical pregnancy (25.7 versus 33.8% (OR 0.68 95% CI 0.52–0.90)) and biochemical test (36.2 versus 45.5% (OR 0.68 95% CI 0.53–0.88)). The per protocol analyses showed the same differences (live birth rate OR 0.66 95% CI 0.47–0.93 and clinical pregnancy rate OR 0.72 95% CI 0.54–0.96). LIMITATIONS, REASONS FOR CAUTION This study is limited by its retrospective design. Furthermore, 56 (16.3%) cases lacked data regarding delivery outcomes, but these were equally distributed between the two groups. WIDER IMPLICATIONS OF THE FINDINGS The lower clinical pregnancy rates per embryo transfer indicate that implantation is hampered after a caesarean section. Its relation with a possible niche (caesarean scar defect) in the uterine caesarean scar needs further study. Our results should be discussed with clinicians and patients who consider an elective caesarean section. STUDY FUNDING/COMPETING INTEREST(S) Not applicable. TRIAL REGISTRATION NUMBER This study has been registered in the Dutch Trial Register (Ref. No. NL7631 http://www.trialregister.nl).

ABSTRACT Caesarean section can result in an indentation of the myometrium at the site of the Caesarean scar, called a niche. Niches can cause symptoms of abnormal uterine blood loss, dysmenorrhoea, chronic pelvic pain and dyspareunia and are possibly related to subfertility. Various other explanations for the cause of subfertility after Caesarean section have been proposed in the literature, such as uterine pathology, intra-abdominal adhesions and women’s reproductive choices. Not all niches cause symptoms and the relation with subfertility and a niche in the uterine scar still needs further study since direct evidence is lacking so far. Based on the limited available evidence, and in combination with observations made during sonographic hysteroscopic evaluations and laparoscopic niche repair, we propose and discuss three hypothetical mechanisms: (i) the environment for sperm penetration and implantation may be detrimental; (ii) there could be a physical barrier to embryo transfer and implantation; and (iii) psychogenic factors may reduce the likelihood of pregnancy. Several innovative surgical treatments have been developed and are being implemented for niche-related problems. Promising results are reported, but more evidence is needed before further implementation in daily practice. The additional value of niche resections should be compared to expectant management or fertility therapies, such as ART, in randomized controlled trials. Therefore, our suggested hypotheses should, for the time being, not be used for justification of any specific procedures outside clinical trials.

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IntroductionA uterine niche is a defect at the site of the uterine caesarean scar that is associated with gynaecological symptoms and infertility. Promising results are reported in cohort studies after a laparoscopic niche resection concerning reduction of gynaecological symptoms in relation to baseline and concerning pregnancy outcomes. However, randomised controlled trials to study the effect of a laparoscopic niche resection on reproductive outcomes in infertile women are lacking. This study will answer the question if laparoscopic niche resection in comparison to expectant management improves reproductive outcomes in infertile women with a large uterine niche.Methods and analysisThe LAPRES study is a randomised, non-blinded, controlled trial, including 200 infertile women with a total follow-up of 2 years. Women with the presence of a large niche in the uterine caesarean scar and unexplained infertility of at least 1 year or failed IVF will be randomly allocated to a laparoscopic niche resection within 6 weeks or to expectant management for at least 9 months. A large niche is defined as a niche with a depth of >50% of the myometrial thickness and a residual myometrium of ≤3 mm on transvaginal ultrasound. Those receiving expectant management will be allowed to receive fertility therapies, including assisted reproductive techniques, if indicated. The primary outcome is time to ongoing pregnancy, defined as a viable intrauterine pregnancy at 12 weeks’ gestation. Secondary outcome measures are time to conception leading to a live birth, other pregnancy outcomes, received fertility therapies after randomisation, menstruation characteristics, patient satisfaction, quality of life, additional interventions, and surgical and ultrasound outcomes (intervention group). Questionnaires will be filled out at baseline, 6, 12 and 24 months after randomisation. Ultrasound evaluation will be performed at baseline and at 3 months after surgery.Ethics and disseminationThe study protocol was approved by the medical ethics committee of the Amsterdam University Medical Centre. (Ref. No. 2017.030). Participants will sign a written informed consent before participation. The results of this study will be submitted to a peer-reviewed journal for publication.Trial registration number: Dutch Trial Register (ref. no. NL6350http://www.trialregister.nl).

Inter-observer agreement between the two non-expert examiners was good for the ESHRE/ESGE (k = 0.74, 95% CI 0.55-0.92) and very good for ASRM and CUME classification systems (k = 0.96, 95% CI 0.88-1.00; and k = 0.91, 95% CI 0.79-1.00), respectively. Agreement between the ESHRE/ESGE and ASRM was moderate for both examiners. Agreement between ESHRE/ESGE and CUME classifications was moderate for examiner 1 and good for examiner 2. Agreement between ASRM and CUME was good for both examiners. Conclusions: The three classifications have good (ESHRE/ESGE) or very good (ASRM, CUME) inter-observer agreement. Agreement between ASRM and CUME was higher than that for ESHRE-ESGE and ASRM and ESHRE-ESGE and CUME. OC15.04 4D ultrasound guidance improves embryo transfer success rates: a randomised controlled trial