COVID-19 risk assessment and safety management operational guidelines for IVF center reopening.

PURPOSE: To promote nationwide dissemination and implementation of COVID-19 Risk Assessment and Safety Management Operational Guidelines, drawn up by SAMeR Task Force in ART centers in Argentina. Our objective is to prevent and mitigate the transmission of SARS-CoV-2 at an institutional level, while reducing the risk of infection among both physicians and patients in the context of a critical scenario in the local and Latin American healthcare system. METHODS: SAMeR Executive Committee set up a crisis committee which was made up of specialists in reproductive medicine, embryology, and healthcare management. A critical and updated review of the advances in science, documents, and recommendations released by other societies (ASRM, ESHRE, IFFS, Red LARA, societies of anesthesiologists, infectious diseases, and Occupational Safety and Health Administration-OSHA) was carried out. Likewise, there were joint meetings with the Ministry of Health of Argentina in order to draw up the guidelines. Simultaneously, ongoing medical training was carried out, thus providing added value to them, including two status surveys of the activities of the monovalent and polyvalent centers according to the country's epidemiological mapping. Four additional recommendations were made, and online training was given to healthcare workers. The aforementioned regulations were first analyzed by the healthcare providers and their practical suggestions were then added to the guidelines. RESULTS: The one-off collaborative work and the actions coordinated with the National ART Program of the Ministry of Health of Argentina resulted in the development and implementation of the present COVID-19 Risk Assessment and Safety Management Operational Guidelines at a national level. SAMeR gave recommendations for the implementation of the Management Guidelines for the center reopening, providing new safety criteria against the threat of viral contagion. A new organizational culture was promoted through the awareness of all the healthcare workers and teaching responsibility. We continue working on the compliance with a new "Code of Conduct and Commitment in Healthcare" and with workplace safety measures. We helped with transforming the theoretical knowledge into practical measures for the healthcare workers in different services, with the aim to prevent, mitigate, and/or handle contingencies at the centers/services and gamete banks, in line with the actions agreed upon with the Ministry of Health. CONCLUSIONS: As an extraordinary and uncertain event, the SARS-CoV-2 pandemic helped consolidate a volunteer-based and collaborative panel of SAMeR experts who developed the COVID-19 Risk Assessment and Safety Management Operational Guidelines as a new and readily available tool for physicians, patients, and gamete banks care. Their implementation has provided specific guidelines to minimize risk for professionals in ART clinics, as well as guaranteeing patient safety.

Current perceptions and decisions of patients about cryopreserved embryos in Argentina. / [Percepciones actuales y decisiones de pacientes acerca de embriones criopreservados en Argentina.]

Introduction: Worldwide there is an increase in the number of assisted reproduction treatments. The developments in culture media and drugs, associated with the occurrence of rapid freezing or vitrification techniques has improved the procedures encouraging transfers of a single embryo per cycle. This generates a greater number of viable surplus embryos. An embryo disposition decision making is a complex phenomenon. Method: Method: This descriptive exploratory study investigates the perceptions and opinions of a sample of 60 participants who have started an assisted reproduction treatment in a specialized Fertility Center of the City of Buenos Aires. Results: The absence of children in the majority of the sample (70.6% still have no children) makes the prevailing option to "continue cryopreservation" (36.67%). The majority, 38.4% (23 people), considers that the option that best represents the embryo is "a child". Although there are relatively few people who have decided to donate their embryos (5 participants), several study participants report having reflected on it (35%). The vast majority (86.6%) of respondents would not be willing to face the costs of maintaining a long-term cryopreservation. Conclusion: After more than three decades of assisted reproduction, Argentinean patients still face a high degree of uncertainty regarding what to do with the surplus embryos. Gaining more in-depth knowledge regarding the decision-making process can help to improve the communication strategies. The normative absences generate that the ARTs users are "disengaged" from their embryos; this hinders the decision making, increasing the risk of accumulating more "abandoned" embryos

Introducción: A nivel mundial se registra un aumento en la cantidad de tratamientos de reproducción asistida. La optimización en medios de cultivo y fármacos, asociado al advenimiento de técnicas de congelamiento rápido o vitrificación han logrado mejorar los procedimientos alentando las transferencias de un único embrión por ciclo, generando un mayor número de embriones excedentes viables. La toma de las decisiones sobre la disposición de los embriones supernumerarios es un fenómeno complejo. Método: Este estudio exploratorio descriptivo indaga las percepciones y opiniones de una muestra de 59 participantes que han comenzado un tratamiento de reproducción asistida en un Centro de Fertilidad especializado de la Ciudad de Buenos Aires. Resultados: La ausencia de hijos en la mayoría de la muestra (70.6% aún no tiene hijos) hace que la opción prevalente sea continuar la criopreservación (35,6%). La mayoría, 40.7% (24 personas) considera que la opción que mejor representa al embrión es "un hijo/a". Si bien son relativamente pocas las personas que han decidido donar sus embriones (5 personas) varios participantes del estudio refieren haber reflexionado sobre ello (43%). La gran mayoría (86,5%) de los encuestados no estaría dispuesta a enfrentar los gastos del mantenimiento de la criopreservación a largo plazo. Conclusión: Se constata que, luego de más de tres décadas de desarrollo de las tecnologías reproductivas, aún existe en Argentina un alto grado de incertidumbre en los pacientes respecto de qué hacer con sus embriones excedentes. Conocer más en profundidad el proceso de toma de decisiones puede contribuir a implementar estrategias comunicacionales.

Abandoned frozen embryos in Argentina: a committee opinion.

Argentina, like many other countries in the region, faces the dilemma of what to do with the increasing accumulation of frozen embryos, which are often abandoned. This report aims to address the issue of abandoned frozen embryos, following the main concerns: 1) when is an embryo considered abandoned, according to regulatory documents; 2) how can the number of cryopreserved abandoned embryos be decreased; and 3) what are the current available options for discarding these abandoned embryos. Issues concerning the fate of abandoned embryos call for a revision of the technical aspects, as well as the symbolic aspects associated with the embryos and their options for discarding. Embryo disposal is a complex and intimate decision, which depends not only, on the quality of the cryopreserved embryo, but also on the social, cultural, economic, labor and health insurance aspects. In the absence of a formal regulatory framework for such decisions in Argentina, current practices and standard procedures face significant developmental hurdles. Among future actions to be developed in the short, medium and long term by this committee are building interdisciplinary teams, fostering patient-awareness, devising guidelines, and enforcing policies regarding embryo abandonment.

Physicians and patients' motivations to perform elective single or double-embryo transfers: A nationwide survey.

OBJECTIVES: To evaluate motivations to perform an elective single embryo transfer (e-SET). METHODS: Cross-sectional surveys to reproductive medicine specialists and to infertile patients undergoing assisted reproductive treatments. RESULTS: In the physician's survey (n = 278), we found that the main reasons for not offering e-SET were the physicians' belief that patients prefer optimizing the pregnancy rates regardless of the potential complications (57.1%). Regarding the decision making process, 76.7% of physicians thought that patients and doctors should make these decisions together and 93.3% would like to have a more formal decision-aid to help with counseling. In the patients' survey (n = 100), 21.3% chose e-SET, while 33% mentioned that complications associated to multiple pregnancies were insufficiently discussed. Among those patients, none chose to have e-SET, while 30% of those who had a full discussion selected e-SET (p = 0.05). CONCLUSIONS: Most physicians did not offer e-SET based on potential patients' negative feelings. Also, almost 30% take important decisions without the patient's participation. Patients that discussed more thoroughly this topic, more frequently selected e-SET. Almost all the physicians surveyed agreed that decision-aids could help in this important shared-decision process. PRACTICE IMPLICATIONS: Decision aids about e-SET vs DET are needed to help patients in the decision making process.

La inhibina (Inh) A producida por células de granulosa humanas actuaría como factor autocrino-paracino regulando el mecanismo de luteinización folicular / Inh A produced by the human granulosa cells would act as autocrinous-paracrinous factor regulating the follicular luteinization mechanism

Las Inh gonadales ejercen un efecto local en la regulación de la foliculogénesis. En éste trabajo se midió la producción de inhibina popr células de granulosa humana en cultivo por un enzimoinmunoensayo específico para las formas A y B encontrándose mayores niveles de Inh A que B (2,89ñ0,88 vs 0,025ñ0,008 ng/1 por 10 cels. n:6, p<0.05). Se detrminó la concentración de inhibinas, Progesterona, Estradiol, FSH y hCG en fluido folicular (FF) obtenido el día de la aspiración ovocitaria en 23 pacientes sometidas a FIV. Se encontró que la concentración de Inh A fue mayor que la de Inh B (6,87ñ1,27 vs 1,24ñ0,23 ng/mg proteína). Se observó una correlación positiva entre la concentración intrafolicular de Inh A y Progesterona (r=0,47 p<0.05), Estradiol (r=0,67 p<0.05) y FSH (r=0,74 p<0.05). También se observó correlación positiva entre los niveles de E y FSH en FF (r=0.56 p<0.05). La Inh B en FF no correlacionó, con ninguno de los parámetros estudiados. Se ensayó el efecto in vitro de la Inh. A en cultivo de células de granulosa inmaduras de rata, que posee la ventaja de tener mayor capacidad proliferativa que las humanas obtenidas por FIV. Se estimuló con FSH (20 ng/ml), Estradiol (500 ng/ml) y TGFß (5 ng/ml) durante 48 hs. Se observó inhibición (p<0,05) de la proliferación medida por incorporación de timidina. (Control: 5543ñ146; Inh 4 ng/ml: 4767ñ174; Inh 40 ng/ml: 3480ñ117 cpm). Esto fue confirmado por MTS (Absorbancia=Control: 1,3ñ0,2; Inh 40 ng/ml: 0,5ñ0,02; p<0,05). Concluímos: a) las células de granulosa humanas provenientes de FIV producen más Inh A que B cultivo, ésta misma relación se observa en FF, b) el contenido de Inh A en FF se correlaciona con la concentración de FSH y esteroides foliculares y c) la Inh A inhibe la proliferación de células de granulosa en cultivo. Estos resultados sugieren que la Inh A actuaría como factor autócrino/parácrino regulando el mecanismo de selección y/o luteinización folicular

La inhibina (Inh) A producida por células de granulosa humanas actuaría como factor autocrino-paracino regulando el mecanismo de luteinización folicular / Inh A produced by the human granulosa cells would act as autocrinous-paracrinous factor regulating the follicular luteinization mechanism

Las Inh gonadales ejercen un efecto local en la regulación de la foliculogénesis. En éste trabajo se midió la producción de inhibina popr células de granulosa humana en cultivo por un enzimoinmunoensayo específico para las formas A y B encontrándose mayores niveles de Inh A que B (2,89ñ0,88 vs 0,025ñ0,008 ng/1 por 10 cels. n:6, p<0.05). Se detrminó la concentración de inhibinas, Progesterona, Estradiol, FSH y hCG en fluido folicular (FF) obtenido el día de la aspiración ovocitaria en 23 pacientes sometidas a FIV. Se encontró que la concentración de Inh A fue mayor que la de Inh B (6,87ñ1,27 vs 1,24ñ0,23 ng/mg proteína). Se observó una correlación positiva entre la concentración intrafolicular de Inh A y Progesterona (r=0,47 p<0.05), Estradiol (r=0,67 p<0.05) y FSH (r=0,74 p<0.05). También se observó correlación positiva entre los niveles de E y FSH en FF (r=0.56 p<0.05). La Inh B en FF no correlacionó, con ninguno de los parámetros estudiados. Se ensayó el efecto in vitro de la Inh. A en cultivo de células de granulosa inmaduras de rata, que posee la ventaja de tener mayor capacidad proliferativa que las humanas obtenidas por FIV. Se estimuló con FSH (20 ng/ml), Estradiol (500 ng/ml) y TGFß (5 ng/ml) durante 48 hs. Se observó inhibición (p<0,05) de la proliferación medida por incorporación de timidina. (Control: 5543ñ146; Inh 4 ng/ml: 4767ñ174; Inh 40 ng/ml: 3480ñ117 cpm). Esto fue confirmado por MTS (Absorbancia=Control: 1,3ñ0,2; Inh 40 ng/ml: 0,5ñ0,02; p<0,05). Concluímos: a) las células de granulosa humanas provenientes de FIV producen más Inh A que B cultivo, ésta misma relación se observa en FF, b) el contenido de Inh A en FF se correlaciona con la concentración de FSH y esteroides foliculares y c) la Inh A inhibe la proliferación de células de granulosa en cultivo. Estos resultados sugieren que la Inh A actuaría como factor autócrino/parácrino regulando el mecanismo de selección y/o luteinización folicular (AU)