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.
Human follicular fluid (hFF), present in the ampullary environment, can reduce the number of sperm bound to the zona pellucida. The aim of the present study was to investigate the effects of follicular fluid on sperm function. The presence of 50% v/v follicular fluid resulted in a significant reduction in the number of bound spermatozoa with respect to control medium (12.7 +/- 5.5 sp HZ(-1) versus 24.6 +/- 5.7 sp HZ(-1), P = 0.03) as measured by the hemizona binding assay. This reduction in zona binding capacity was not associated with a loss of sperm viability, motility or a premature acrosomal reaction. When capacitated spermatozoa were previously exposed 1 h to follicular fluid, a significant reduction in the number of alpha-d-mannose binding sites on sperm head was detected (23.7 +/- 3.1% versus 15.5 +/- 2.4%, P < 0.05). In addition, sperm fertilizing capacity (assessed as the acrosome reaction to ionophore challenge score) in the presence of follicular fluid was also diminished (38.0 +/- 4.8% versus 22.6 +/- 4.9%, P < 0.01). No modification in the pattern of protein tyrosine phosphorylation which occurs during capacitation was observed in the presence of the fluid. Taken together, the results indicate that the decrease in sperm zona-binding capacity observed in the presence of hFF was related to a lower number of sperm containing alpha-d-mannose receptors.
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.
Objective: We compared the efficacy, safety, and immunogenicity of a biosimilar recombinant human folliclestimulating hormone (Folitime ® ) with Gonal-f ® in women undergoing ovarian stimulation for in-vitro fertilization.Methods: This randomized (1:1), multicenter, assessor-blinded, non-inferiority, parallel-group, controlled study conducted at four infertility clinics in Argentina included infertile normogonadotropic women with ages below 39 years, with menstrual cycles of 25/35 days and a body mass index of 18-32 kg/m2 undergoing assisted reproductive technology therapy. During a 5-day fixeddose phase, the women received 225 IU/day of Folitime ® (n=49) or Gonal-f ® (n=44), followed by a dose-adaptation phase up to a maximum of 450 IU/day. The non-inferiority margin for oocyte retrieval was estimated at -4 oocytes (one-sided test). Immunogenicity was investigated on days 9 and 84, following the start of treatment.Results: The mean number of oocytes retrieved was 12.6 (SD 7.4) in the Folitime ® group and 13.4 (SD 6.9) in the Gonal-f ® group (per protocol analysis, 95% confidence interval = -3.82; 2.33), within the non-inferiority margin. Pregnancy rate at week 10 was 24.4% among subjects treated with Folitime ® and 19.5% for subjects treated with Gonal-f ® . One serious adverse drug reaction-late mild ovarian hyper stimulation syndrome and deep venous thrombosis in the left deep jugular vein-occurred in a subject treated with Folitime ® . None of the subjects developed antibodies against the study drugs. There were no unexpected safety findings.Conclusions: Folitime ® is non-inferior to Gonal-f ® , with no differences in the safety profile and has been approved as a biosimilar in Argentina.
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