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Background Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated. We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology. We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology. We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo. Results Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time ( P  < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P  = 0.005 and P  = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation. Conclusions Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled utilization of these instruments further expands. Trial registration NCT02246309 Registered September 18, 2014.

One of the drawbacks of fetoscopic endoluminal tracheal occlusion (FETO) for congenital diaphragmatic hernia is the need for a second invasive intervention to reestablish airway patency. The \"Smart-TO\" (Strasbourg University-BSMTI, France) is a new balloon for FETO, which spontaneously deflates when positioned near a strong magnetic field, e.g., generated by a magnetic resonance image (MRI) scanner. Translational experiments have demonstrated its efficacy and safety. We will now use the Smart-TO balloon for the first time in humans. Our main objective is to evaluate the effectiveness of prenatal deflation of the balloon by the magnetic field generated by an MRI scanner. These studies were first in human (patients) trials conducted in the fetal medicine units of Antoine-Béclère Hospital, France, and UZ Leuven, Belgium. Conceived in parallel, protocols were amended by the local Ethics Committees, resulting in some minor differences. These trials were single-arm interventional feasibility studies. Twenty (France) and 25 (Belgium) participants will have FETO with the Smart-TO balloon. Balloon deflation will be scheduled at 34 weeks or earlier if clinically required. The primary endpoint is the successful deflation of the Smart-TO balloon after exposure to the magnetic field of an MRI. The secondary objective is to report on the safety of the balloon. The percentage of fetuses in whom the balloon is deflated after exposure will be calculated with its 95% confidence interval. Safety will be evaluated by reporting the nature, number, and percentage of serious unexpected or adverse reactions. These first in human (patients) trials may provide the first evidence of the potential to reverse the occlusion by Smart-TO and free the airways non-invasively, as well a safety data.

OBJECTIVES: We aimed to show how increased experience of a surgery team in fMMC repair influences maternal andfetal/neonatal outcomes. MATERIAL AND METHODS: We compare perinatal results of fMMC repair in our Fetal Surgery Center (FSC) in cohort groups forthe early period (2005–2011 year; previous — PFSC, n = 46) and current period (2012–2015 year; current — CFSC, n = 74)to results of the randomized Management of Myelomeningocele Study (MOMS, 78 patients). RESULTS: The maternal morbidity due to fMMC repair was low and there was no difference comparing CFSC to PFSC andMOMS. The frequency of iatrogenic preterm labor (iPTL) ≤ 30 weeks of gestation decreased from 34.1% in PFSC to 23.9%in CFSC. Iatrogenic preterm premature rupture of membranes (iPPROM) was a common complication after fMMC repair inall cohorts. The total reduction rate of hindbrain hernation (HH) was similar in CFSC — 90.3% and PFSC — 82.1%. CONCLUSIONS: The increasing experience of our surgery team in fMMC repair majorly decreased the risk of iPTL.

In this trial involving fetuses with severe left congenital diaphragmatic hernia, fetoscopic endoluminal tracheal occlusion at 27 to 29 weeks of gestation significantly increased survival to discharge, but it resulted in an increased incidence of preterm, prelabor rupture of membranes and preterm birth.

BackgroundFetoscopic endoluminal tracheal occlusion (FETO) has been shown to improve survival of infants with congenital diaphragmatic hernia (CDH). However, there are concerns that FETO may lead to tracheomegaly, tracheomalacia and related complications.MethodsA systematic review was conducted to estimate the prevalence of symptomatic tracheal complications in infants who underwent FETO for CDH. Presence of one or more of the following was considered as tracheal complication: tracheomalacia, stenosis, laceration or tracheomegaly with symptoms such as stridor, effort-induced barking cough, recurrent chest infections or the need for tracheostomy, tracheal suturing, or stenting. Isolated tracheomegaly on imaging or routine bronchoscopy without clinical symptoms was not considered as tracheal morbidity. Statistical analysis was performed using the metaprop command on Stata V.16.0.ResultsA total of 10 studies (449 infants) were included (6 retrospective cohort, 2 prospective cohort and 2 randomised controlled trials). There were 228 infants who survived to discharge. Prevalence rates of tracheal complications in infants born alive were 6% (95% CI 2% to 12%) and 12% (95% CI 4% to 22%) in those who survived to discharge. The spectrum of severity ranged from relatively mild symptoms such as effort-induced barking cough to the need for tracheostomy/tracheal stenting.ConclusionA significant proportion of FETO survivors have symptomatic tracheal morbidities of varying severity. Units that are planning to adopt FETO for managing CDH should consider ongoing surveillance of survivors to enable early identification of upper airway issues. Inventing FETO devices that minimise tracheal injury is needed.

Objective: To determine predictors of survival in monochorionic diamniotic twins with selective fetal growth restriction type II (sFGR-II), with or without twin-to-twin transfusion syndrome (TTTS), treated by endoscopic placental laser coagulation. Methods: Laser surgery was performed at 20 (15-27) weeks' gestation in 405 cases of sFGR-II with and 142 without coexisting TTTS. Multivariable logistic regression analysis was performed to determine significant predictors of survival to discharge from hospital. Results: There was survival of the small twin in 216 (39.5%) and of the large twin in 379 (69.3%) cases. Significant predictors of survival of both the small and larger twin were ductus venosus Doppler findings in the small twin, gestational age at laser and cervical length, but not the presence of TTTS or Doppler findings in the large twin. Conclusions: In sFGR-II, survival after laser surgery is primarily dependent on the condition of the small twin.

In this randomized trial involving fetuses with moderate left congenital diaphragmatic hernia, fetoscopic endoluminal tracheal occlusion at 30 to 32 weeks of gestation did not significantly increase survival to discharge from a NICU or reduce the need for oxygen supplementation at 6 months, and it increased the risks of preterm, prelabor rupture of membranes and preterm birth. The surgical technique is shown in an animated video.

Purpose To provide a comprehensive report of the experience gained in the prenatal treatment of congenital diaphragmatic hernia (CDH) using fetoscopic endoluminal tracheal occlusion (FETO) following its implementation at a newly established specialized fetal medicine center. Methods Mothers of fetuses with severe CDH were offered prenatal treatment by FETO. Results Between 2018 and 2021, 16 cases of severe CDH underwent FETO. The median gestational age (GA) at balloon insertion was 28.4 weeks (IQR 27.8–28.6). The median GA at delivery was 37 weeks (IQR 34.4–37.8). The survival rate was 8/16 cases (50%). None of the survivors required home oxygen therapy at 6 months of age. Comparison between the survivors and deceased showed that survivors had balloon insertion 1 week earlier (27.8 vs. 28.4 weeks, p  = 0.007), a higher amniotic fluid level change between pre- to post-FETO (3.4 vs 1.3, p  = 0.024), a higher O/E LHR change between pre- to post-FETO (50.8 vs. 37.5, p  = 0.047), and a GA at delivery that was 2 weeks later (37.6 vs. 35.4 weeks, p  = 0.032). Conclusions The survival rate at 6 months of age in cases of severe CDH treated with FETO in our center was 50%. Our new fetal medicine center matches the performance of other leading international centers.

Objectives: To evaluate if fetal endoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia (CDH) using a 1.0-mm fetoscope improves neonatal outcome. Method: Between January 2006 and December 2008, a controlled study was conducted at a single center in which FETO was proposed for fetuses with severe isolated CDH (lung-to-head ratio <1.0) and liver herniation to the thoracic cavity but no other detectable anomalies at diagnosis (<26 weeks). FETO was performed under maternal epidural and fetal intramuscular anesthesia, guided by ultrasonography and 1.0-mm fetoscope between 26 and 30 weeks. All cases submitted to FETO were delivered by ex utero intrapartum therapy procedure. Postnatal therapy was the same for both treated fetuses and controls. The primary outcome was neonatal survival (up to 28 days after birth). Results: A total of 35 women met the inclusion criteria, and in 17 of them, fetal intervention was intended. However, in 1 case, it was not possible to insert the balloon inside the fetal trachea because of placental bleeding. FETO was therefore successfully performed in 16 fetuses with severe CDH. Eighteen cases received no prenatal intervention and served as the control group. Mean gestational age at diagnosis was similar in both groups (p > 0.05). Delivery occurred at 35.6 (range: 28–38) weeks in the FETO group and at 37.5 (range: 31–40) weeks (p = 0.18) among controls. Nine of 17 (52.9%) infants in the FETO group and 1 of 18 (5.6%) in the control group survived (p < 0.01). Severe pulmonary arterial hypertension was present in 8/17 (47.1%) infants from the FETO group and in 16/18 (88.9%) controls (p = 0.01). Conclusion: The present study shows that FETO using a 1.0-mm fetoscope is feasible and may improve neonatal outcome in severe CDH.

Objective To develop a risk prediction model for preterm premature rupture of membranes (PPROM) after fetal endoscopy laser coagulation (FLC) for Twin-to-Twin Transfusion Syndrome (TTTS), identifying related influencing factors. Methods A retrospective analysis was conducted on 414 parturients from six Chinese hospitals treated with FLC for TTTS between January 2016 and January 2025. Patients were divided into non-occurrence ( n  = 263) and occurrence groups ( n  = 151) based on PPROM during pregnancy. Logistic regression identified predictors, establishing the risk prediction model. Results Univariate and multivariate logistic analyses revealed postoperative amniotic fluid leakage, operation time, and intraoperative amniotic fluid reduction rate as risk factors, while preoperative cervical canal length and Trocar insertion distance from the internal cervical OS were associated with reduced risk (all P  < 0.05). ROC curve analysis showed an area under the curve of 0.802 (95% CI: 0.700–0.904), indicating good predictive efficacy. The goodness-of-fit test ( P  = 0.165 > 0.05) confirmed model fit, and calibration curves demonstrated acceptable accuracy. Clinical decision curves indicated net benefit. Conclusion This model, incorporating postoperative amniotic fluid leakage, operation time, intraoperative amniotic fluid reduction rate, preoperative cervical canal length, and Trocar insertion distance, effectively predicts PPROM risk after FLC for TTTS. It can assess risks clinically and guide interventions to prolong pregnancy and improve outcomes.