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The prolonged lockdown of health facilities providing non-urgent gamete cryopreservation-as currently recommended by many reproductive medicine entities and regulatory authorities due to the SARS-CoV-2 pandemic will be detrimental for subgroups of male infertility patients. We believe the existing recommendations should be promptly modified and propose that the same permissive approach for sperm banking granted for men with cancer is expanded to other groups of vulnerable patients. These groups include infertility patients (eg, azoospermic and cryptozoospermic) undergoing medical or surgical treatment to improve sperm quantity and quality, as well as males of reproductive age affected by inflammatory and systemic auto-immune diseases who are about to start treatment with gonadotoxic drugs or who are under remission. In both scenarios, the "fertility window" may be transitory; postponing diagnostic semen analysis and sperm banking in these men could compromise the prospects of biological parenthood. Moreover, we provide recommendations on how to continue the provision of andrological services in a considered manner and a safe environment. Our opinion is timely and relevant given the fact that fertility services are currently rated as of low priority in most countries.

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The POSEIDON group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) has introduced "the ability to retrieve the number of oocytes needed to achieve at least one euploid embryo for transfer" as an intermediate marker of successful outcome in IVF/ICSI cycles. This study aimed to develop a novel calculator to predict the POSEIDON marker. We analyzed clinical and embryonic data of infertile couples who underwent IVF/ICSI with the intention to have trophectoderm biopsy for preimplantation genetic testing for aneuploidy. We used the negative binomial distribution to model the number of euploid blastocysts and the adaptive LASSO (Least Absolute Shrinkage and Selection Operator) method for variable selection. The fitted model selected female age, sperm source used for ICSI, and the number of mature (metaphase II) oocytes as predictors (p < 0.0001). Female age was the most important factor for predicting the probability of a blastocyst being euploid given each mature oocyte (loglikelihood of age [adjusted for sperm source]: 30.9; df = 2; p < 0.0001). The final predictive model was developed using logistic regression analysis, and internally validated by the holdout method. The predictive ability of the model was assessed by the ROC curve, which resulted in an area under the curve of 0.716. Using the final model and mathematical equations, we calculated the individualized probability of blastocyst euploidy per mature retrieved oocyte and the minimum number of mature oocytes required to obtain ≥1 euploid blastocyst-with their 95% confidence interval [CI]-for different probabilities of success. The estimated predicted probabilities of a mature oocyte turn into a euploid blastocyst decreased progressively with female age and was negatively modulated overall by use of testicular sperm across age (p < 0.001). A calculator was developed to make two types of predictions automatically, one using pretreatment information to estimate the minimum number of mature oocytes to achieve ≥1 euploid blastocyst, and another based on the actual number of mature oocytes collected/accumulated to estimate the chances of having a euploid blastocyst using that oocyte cohort for IVF/ICSI. The new ART calculator may assist in clinical counseling and individualized treatment planning regarding the number of oocytes required for at least one euploid blastocyst in IVF/ICSI procedures.

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This multicenter study evaluated the reliability of the recently published ART calculator for predicting the minimum number of metaphase II (MII) oocytes (MIImin) to obtain at least one euploid blastocyst in patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). We used clinical and embryonic retrospective data of 1,464 consecutive infertile couples who underwent IVF/ICSI with the intention to have preimplantation genetic testing for aneuploidy. The validation procedure followed a stepwise approach. Firstly, we assessed the distribution of euploid blastocysts per patient and found that it followed a negative binomial distribution. Secondly, we used generalized linear models and applied the Lasso procedure-including MII oocytes to adjust the data-to select the factors predicting the response variable "euploid blastocyst." Third, a logistic regression model-fit to the binomial response euploid (yes/no) for each MII oocyte-was built using the relevant factors. The observational unit was the "woman" whereas the response was the pair (m, n), where n is the number of retrieved MII oocytes and m the corresponding number of euploid blastocysts. The model was internally validated by randomly splitting the data into training and validation sets. The R-squares (~0.25) and the area under the ROC curve (~0.70) did not differ between the training and validation datasets. Fourth, mathematical equations and the calculated probabilities generated by the validation model were used to determine the MIImin required for obtaining at least one euploid blastocyst according to different success probabilities. Lastly, we compared the fittings generated by the validation model and the ART calculator and assessed the predictive value of the latter using the validation dataset. The fittings were sufficiently close for both the estimated probabilities of blastocyst euploid per MII oocyte (r = 0.91) and MIImin (r = 0.88). The ART calculator positive predictive values, i.e., the frequency of patients with at least one euploid blastocyst among those who achieved the estimated MIImin, were 84.8%, 87.5%, and 90.0% for 70%, 80%, and 90% predicted probabilities of success, respectively. The ART calculator effectively predicts the MIImin needed to achieve at least one euploid blastocyst in individual patients undergoing IVF/ICSI. The prediction tool might be used for counseling and planning IVF/ICSI treatments.

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In Fertility Centers, quality should be measured by how well the organization complies with pre-defined requirements, and by how quality policies are implemented and quality objectives achieved. Having a quality management system (QMS) is a mandatory requirement for IVF centers established in most countries with regulatory guidelines, including Brazil. Nevertheless, none of the regulatory directives specify what a QMS must have in detail or how it should be implemented and/or maintained. ISO 9001 is the most important and widespread international requirement for quality management. ISO 9001 standards are generic and applicable to all organizations in any economic sector, including IVF centers. In this review, we discuss how we implemented QMS according to ISO 9001 and what we achieved 5 years later. In brief, with ISO we defined our structure, policies, procedures, processes and resources needed to implement quality management. In addition, we determined the quality orientation of our center and the quality objectives and indicators used to guarantee that a high-quality service is provided. Once measuring progress became part of our daily routine, quantifying and evaluating the organization's success and how much improvement has been achieved was an inevitable result of our well-established QMS. Several lessons were learned throughout our quality journey, but foremost among them was the creation of an internal environment with unity of purpose and direction; this has in fact been the key to achieving the organization's goals.

Na clínica de reprodução humana, a qualidade deve ser medida pela maneira como a organização cumpre os requisitos pré-definidos, e pela forma como as políticas de qualidade são implementadas e os objetivos de qualidade alcançados. Ter um sistema de gestão da qualidade (SGQ) é um requisito obrigatório para centros de fertilização in vitro estabelecidos na maioria dos países com diretrizes regulatórias, incluindo o Brasil. No entanto, nenhuma das diretivas regulamentares especifica o que um SGQ deve ter em detalhe ou como ele deve ser implementado e/ou mantido. A norma ISO 9001 é a exigência internacional mais importante e adotada mundialmente para a gestão da qualidade. Os conceitos da norma ISO 9001 são genéricos e aplicáveis a todas as organizações em qualquer setor económico, incluindo as clínicas de fertilização in vitro (ou bancos de células e tecidos germinativos tipo 2, como denominados no Brasil pela Agência Nacional de Vigilância Sanitária). Neste artigo, discutimos como implementamos um SGQ de acordo com a norma ISO 9001 e o que conseguimos 5 anos mais tarde. Em suma, com a norma ISO definimos nossa estrutura, políticas, procedimentos, processos e recursos necessários para implementar a gestão da qualidade. Além disso, determinamos a orientação da qualidade do nosso centro além dos objetivos de qualidade e indicadores utilizados para garantir que um serviço de alta qualidade seja fornecido para nossos clientes. A partir do momento que a mensuração do progresso tornou-se parte da nossa rotina diária, quantificar e avaliar o sucesso da organização e os resultados atingidos passou a ser uma consequência inevitável de um SGQ bem estabelecido. Várias lições foram aprendidas ao longo de nossa jornada de qualidade, mas o mais importante foi a criação de um ambiente interno com unidade de propósito e direção, que se tornou peça chave para alcançar os objetivos da organização.

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Two articles recently published in Reproductive BioMedicine Online described how fertility centres in the USA and Brazil implemented air quality control to newly designed facilities. In both case scenarios, a highly efficient air filtration was achieved by installing a centred system supplying filtered air to the IVF laboratory and other critical areas, combining air particulate and volatile organic compound (VOC) filtration. Evaluating retrospective data of over 3000 cycles from both centres, live birth rates were increased by improvements in air quality and laboratory environment. This commentary discusses some of the key aspects of air contamination in the IVF settings, and highlights the fact that a risk management analysis taking into consideration all variables that play a role in air contamination is paramount for the reduction of the risk of poor IVF outcomes due to improper air quality conditions.

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This article describes how Androfert complied with the Brazilian Cells and Germinative Tissue Directive with regard to air quality standards and presents retrospective data of intracytoplasmic sperm injection (ICSI) outcomes performed in controlled environments. An IVF facility, composed of reproductive laboratories, operating room and embryo-transfer room, was constructed according to cleanroom standards for air particles and volatile organic compounds. A total of 2060 couples requesting IVF were treated in the cleanroom facilities, and outcome measures compared with a cohort of 255 couples treated at a conventional facility from the same practice before implementation of cleanrooms. No major fluctuations were observed in the cleanroom validation measurements over the study period. Live birth rates increased (35.6% versus 25.8%; P=0.02) and miscarriage rates decreased (28.7% versus 20.0%; P=0.04) in the first triennium after cleanroom implementation. Thereafter, the proportion of high-quality embryos steadily increased whereas pregnancy outcomes after ICSI were sustained despite the increased female age and decreased number of embryos transferred. This study demonstrates the feasibility of handling human gametes and culturing embryos in full compliance with the Brazilian directive on air quality standards and suggests that performing IVF in controlled environments may optimize its outcomes. Regulatory agencies in many countries have issued directives including specific requirements for air quality standards in embryology facilities. This article describes how we complied with the Brazilian Cells and Germinative Tissue Directive with regard to air quality standards. It also presents results of IVF cycles performed in controlled environments. An IVF facility, composed of reproductive laboratories, operating room and embryo transfer room, was constructed according to cleanroom standards for air particles and volatile organic compounds. The cleanest area was the embryology laboratory, followed by the operating room and embryo transfer room. A total of 2060 couples requesting IVF were treated in the cleanroom facilities, and outcome measures compared with a cohort of 255 couples treated at a conventional facility. Live birth rates increased by 37% and miscarriage rates decreased by 30% in the first triennium after cleanroom implementation. Thereafter, the proportion of high-quality embryos steadily increased whereas pregnancy outcomes after ICSI were sustained despite the increased female age and decreased number of embryos transferred. We demonstrate the feasibility of handling human gametes and culturing embryos in full compliance with the Brazilian Directive on air quality standards and suggest that performing IVF in controlled environments may optimize its outcomes.

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