Background: Early cumulus cell removal combined with early rescue intracytoplasmic sperm injection (ICSI) has been widely practiced in many in vitro fertilization (IVF) centers in China in order to avoid total fertilization failure. This study aimed to investigate the effects of early cumulus cell removal alone after 4 h co-incubation of gametes (4 h group) on the pregnancy and neonatal outcomes as compared with the conventional cumulus cell removal after 20 h of insemination (20 h group) in patients undergoing IVF. Methods: This retrospective cohort study included 1784 patients who underwent their first fresh cleavage embryo transfer at the Centre for Assisted Reproduction of Shanghai First Maternity and Infant Hospital from June 2016 to December 2018 (4 h group, n=570; 20 h group, n=1214). There were 1073 infants delivered after the embryo transfer (4 h group, n=337; 20 h group, n=736). A logistic regression analysis was performed to examine the independent association between early cumulus cell removal and pregnancy outcomes after adjustment for the potential confounders. The neonatal outcomes between the two groups were compared.Result(s): The 4 h group had similar pregnancy outcomes, including biochemical pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, miscarriage rate, ectopic pregnancy rate, multiple pregnancy rate, live birth rate, when compared with the 20 h group. Both groups had comparable singleton and twin delivery rates (32.9% versus 33.5% and 13.2% versus 13.9%, respectively). There were 1073 infants delivered after the embryo transfer (4 h group, n=337; 20 h group, n=736). In both singleton and twin gestations, the preterm birth rate and very preterm birth rate, mean birth weight, mean gestational age, sex ratio at birth and rate of congenital birth defects in the 4 h group were similar to those in the 20 h group. In addition, Z-scores (gestational age- and sex-adjusted birthweight), the rates of small for gestational age, very small for gestational age, large for gestational age and very large for gestational age infants were also similar between the two groups in singleton gestations.Conclusion(s): Early cumulus cell removal alone was not associated with adverse pregnancy and neonatal outcomes in patients undergoing IVF. Thus, early cumulus cell removal to assess for a potential early rescue ICSI seems to be safe in terms of pregnancy and live birth outcomes.
Background: Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in reproductive women where abnormal folliculogenesis is considered as a common characteristic. Our aim is to evaluate the potential of follicular fluid (FF) Raman spectra to predict oocyte development and pregnancy outcome, so as to prioritize the best promising oocyte for implantation, reducing both physiological and economical burdens of PCOS patients. In addition, the altered metabolic profiles will be identified to explore the aetiology and pathobiology of PCOS. Methods: In this study, follicular fluid samples obtained from 150 PCOS and 150 non-PCOS women were measured with Raman spectroscopy. Individual Raman spectrum was analyzed to find biologic components contributing to the occurrence of PCOS. More importantly, the Raman spectra of follicular fluid from the 150 PCOS patients were analyzed via machine-learning algorithms to evaluate their predictive value for oocyte development potential and clinical pregnancy. Results: Mean-centered Raman spectra and principal component analysis showed global differences in the footprints of follicular fluid between PCOS and non-PCOS women. Two Raman zones (993-1,165 cm-1 and 1,439-1,678cm-1) were identified for describing the largest variances between the two groups, with the former higher and the latter lower in PCOS FF. The tentative assignments of corresponding Raman bands included phenylalanine and β -carotene. Moreover, it was found that FF, in which oocytes would develop into high-quality blastocysts and obtain high clinical pregnancy rate, were detected with lower quantification of the integration at 993-1,165 cm-1 and higher quantification of the integration at 1,439-1,678 cm-1 in PCOS. In addition, based on Raman spectra of PCOS FF, the machine-learning algorithms via the fully connected artificial neural network (ANN) achieved the overall accuracies of 90% and 74% in correctly assigning oocyte developmental potential and clinical pregnancy, respectively. Conclusions: The study suggests that the PCOS displays unique metabolic profiles in follicular fluid which could be detected by Raman spectroscopy. Specific bands in Raman spectra have the biomarker potential to predict the oocyte development and pregnancy outcome for PCOS patients. Importantly, these data may provide some valuable biochemical information and metabolic signatures that will help us to understand the abnormal follicular development in PCOS.
Background: Time-lapse imaging system (TLS) is a newly developed non-invasive embryo assessment system. Compared with conventional incubators, it provides stable culture condition and consistent observation of embryo development, thereby improving embryo quality and selection. In theory, these benefits could improve clinical outcomes of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Although this system has been routinely used in many IVF centers globally, it remains unclear if the TLS results in higher cumulative live birth rate and high-quality evidence is warranted. The purpose of this study is to compare the effectiveness of the TLS with conventional incubators in infertile diminished ovarian reserve (DOR) patients. Methods: This study is a double-blind randomized controlled clinical trial (1:1 treatment ratio of TLS vs. conventional incubator). A total of 730 DOR patients undergoing the first or second cycle of IVF or ICSI will be enrolled and randomized into two parallel groups. Participants in group A will undergo embryo culture and selection in the TLS, and participants in group B will undergo embryo culture in the conventional incubators and embryo selection by the morphological characteristics. The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomization. This study is powered to detect an absolute difference of 10% (35% vs 25%) at the significance level of 0.05 and 80% statistical power based on a two-sided test. Discussion: The results of this study will provide evidence for the efficacy and safety of time-lapse system compared with conventional incubators in patients with DOR undergoing IVF/ICSI. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027746. Registered on 24 Nov 2019.
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