Education of the clinical embryology laboratory professional: development of a novel program delivered in a laboratory medicine department

Clinical embryologists are responsible for the handling, evaluation, and care of human gametes and preimplantation embryos within the context of an assisted reproductive technology laboratory. They are integral members of a team of professionals who provide care for fertility patients. Despite the increasing recognition of clinical embryologists as professionals, training requirements, continuing professional development, and appropriate credentialing have lagged in several countries. In many cases, individuals enter the profession with training limited to technical aspects provided by individual laboratory directors through an apprenticeship model. In this article, we present the rationale for rigorous formal training in clinical embryology, introduce CanEMB competencies for practicing professional clinical embryologists that are founded on CanMEDs role principles, and present a nascent Masters of Health Sciences degree program in Laboratory Medicine with a specialization in clinical embryology. This 2-year program has unique features including a Clinical Embryology Skills Development Laboratory, research capstone project, and 200-hour placement within a practicing assisted reproductive technology laboratory. Importantly, this program is delivered through a university-based Department of Laboratory Medicine and Pathobiology in partnership with a Department of Obstetrics and Gynecology. Thus, this program represents a formal acceptance of clinical embryology as a clinical laboratory science. It can be adopted elsewhere to provide a relevant, robust education that will meet current and future needs of the profession. Clinical embryologists are responsible for the handling, evaluation, and care of human gametes and preimplantation embryos within the context of an assisted reproductive technology laboratory. They are integral members of a team of professionals who provide care for fertility patients. Despite the increasing recognition of clinical embryologists as professionals, training requirements, continuing professional development, and appropriate credentialing have lagged in several countries. In many cases, individuals enter the profession with training limited to technical aspects provided by individual laboratory directors through an apprenticeship model. In this article, we present the rationale for rigorous formal training in clinical embryology, introduce CanEMB competencies for practicing professional clinical embryologists that are founded on CanMEDs role principles, and present a nascent Masters of Health Sciences degree program in Laboratory Medicine with a specialization in clinical embryology. This 2-year program has unique features including a Clinical Embryology Skills Development Laboratory, research capstone project, and 200-hour placement within a practicing assisted reproductive technology laboratory. Importantly, this program is delivered through a university-based Department of Laboratory Medicine and Pathobiology in partnership with a Department of Obstetrics and Gynecology. Thus, this program represents a formal acceptance of clinical embryology as a clinical laboratory science. It can be adopted elsewhere to provide a relevant, robust education that will meet current and future needs of the profession. In narratives describing the Nobel prize–winning journey toward producing the first human conceived through in vitro fertilization (IVF), Robert Edwards regularly emphasized the instrumental role played by Jean Purdy (1Gosden R. Jean Marian Purdy remembered - the hidden life of an IVF pioneer.Hum Fertil (Camb). 2018; 21: 86-89Crossref PubMed Scopus (6) Google Scholar, 2Edwards R. Steptoe P. A matter of life: the story of a medical breakthrough. Hutchinson, London1980Google Scholar). Trained as a registered nurse, Purdy joined the Edwards laboratory in 1968 and was charged with managing the embryo laboratory (1Gosden R. Jean Marian Purdy remembered - the hidden life of an IVF pioneer.Hum Fertil (Camb). 2018; 21: 86-89Crossref PubMed Scopus (6) Google Scholar, 3Johnson M.H. IVF: the women who helped make it happen.Reprod Biomed Soc Online. 2019; 8: 1-6Crossref PubMed Scopus (6) Google Scholar). Although the laboratory was working with animal models before this time, Edwards had just forged his collaboration with Patrick Steptoe, and the trio embarked on an intense research program that culminated in the birth of Louise Brown just 10 years later (4Johnson M.H. Robert Edwards: the path to IVF.Reprod Biomed Online. 2011; 23: 245-262Abstract Full Text Full Text PDF PubMed Scopus (50) Google Scholar). Purdy is hence widely regarded as the first clinical embryologist, and her resourcefulness and insights contributed to various successes along the way (1Gosden R. Jean Marian Purdy remembered - the hidden life of an IVF pioneer.Hum Fertil (Camb). 2018; 21: 86-89Crossref PubMed Scopus (6) Google Scholar). In the 45 years since Brown’s historic birth, remarkable developments in pharmacology, cell biology, and engineering have directly impacted the field of assisted reproductive technology (ART), resulting in the implementation of new and increasingly challenging laboratory procedures. The growing demands on the expertise and capabilities of clinical embryologists have led to their assuming increasing importance and responsibility within the ART team, perhaps more reflective of Purdy’s role. Continued advances in gene editing (5Ranisch R. Germline genome editing versus preimplantation genetic diagnosis: Is there a case in favour of germline interventions?.Bioethics. 2020; 34: 60-69Crossref PubMed Scopus (32) Google Scholar, 6Ledford H. CRISPR babies: when will the world be ready?.Nature. 2019; 570: 293-296Crossref PubMed Scopus (15) Google Scholar) and induced pluripotent stem cell biology (7Gell J.J. Clark A.T. Restoring fertility with human induced pluripotent stem cells: are we there yet?.Cell Stem Cell. 2018; 23: 777-779Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar, 8Yamashiro C. Sasaki K. Yabuta Y. Kojima Y. Nakamura T. Okamoto I. et al.Generation of human oogonia from induced pluripotent stem cells in vitro.Science. 2018; 362: 356-360Crossref PubMed Scopus (158) Google Scholar) promise revolutionary changes to the future of infertility care, for which clinical embryologists must be poised to properly implement. Thus, clinical embryologists need rigorous knowledge of reproductive physiology, genetics, theory underlying the techniques to be mastered, and principles to guide ethical dilemmas that regularly emerge in this field. The clinical embryologist has become more of a practitioner and generally provides critical advice and insight that directly impact patient care. The consequences of errors in performance or judgment on the part of the clinical embryologist can lead to serious medical errors with long-term consequences for both the patient and the clinic treating the patient (9Alteri A. Bosco L. Chamayou S. Casciani V. Cervi M. Cecchele A. et al.The paradox of the Italian clinical embryologist in the national public health system: hints towards harmonization of a postgraduate educational curriculum.Hum Fertil (Camb). 2022; 1–5Google Scholar). Concomitant with their ascending importance, the clinical embryologist has advanced to assume roles in communicating health information on gametes and embryos to other health care team members and patients as well. However, the full recognition of clinical embryologists as health care professionals is incomplete, and concomitant regulations regarding the education, training, certification, licensing, and continued professional development remain poorly defined or deficient in several countries, including Canada and the United States (10McDermott O. Ronan L. Butler M. A comparison of assisted human reproduction (AHR) regulation in Ireland with other developed countries.Reprod Health. 2022; 19: 62Crossref PubMed Scopus (5) Google Scholar). The purpose of this article is to present the rationale for rigorous formal training in clinical embryology and considerations in the curriculum development of a novel Masters of Health Sciences (MHSc) degree program in Laboratory Medicine with a specialization in clinical embryology that was recently established to meet this need. This program is delivered through a unique partnership between the Department of Obstetrics and Gynecology and Department of Laboratory Medicine and Pathobiology (LMP) at the University of Toronto. In several countries, including Canada, governmental regulations regarding training and continuing education of clinical embryologists are nonexistent. To address this void, the embryology special interest groups within national fertility societies, including the Canadian Fertility and Andrology Society, have developed guidelines and examinations for certification (9Alteri A. Bosco L. Chamayou S. Casciani V. Cervi M. Cecchele A. et al.The paradox of the Italian clinical embryologist in the national public health system: hints towards harmonization of a postgraduate educational curriculum.Hum Fertil (Camb). 2022; 1–5Google Scholar, 11Alpha Scientists in Reproductive MedicineThe Alpha Consensus Meeting on the professional status of the clinical embryologist: proceedings of an expert meeting.Reprod Biomed Online. 2015; 30: 451-461Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar). Although this is a welcome and important initiative, it must be noted that in most cases, these guidelines are completely voluntary and left to the discretion of individual clinics or individual clinical embryologists because these societies possess neither the legal authority nor the infrastructure required to ensure compliance. However, a critical need is access to appropriately designed training programs to develop and support the ability of individuals to meet these guidelines and prepare clinical embryologists for assimilation of future technological advances. Historically, clinical embryologists in Canada and elsewhere have been informally trained by an IVF laboratory director or manager. The quality of this apprenticeship model of training is variable and largely unregulated. Many entering the field through this route have university baccalaureate degrees but in fields unrelated to embryology. As a result, basic knowledge of physiology, genetics, and molecular and cell biology is inconsistent or incomplete and not adequately provided in an apprenticeship model of training. The knowledge thus obtained does not enable a deep understanding sufficient for today’s dynamic environment of constant innovation, risk management needs, and ever-advancing sophisticated technologies in the IVF laboratory. Consequently, a variety of part-time and distance-learning graduate programs were developed to provide a documented review of history, general knowledge, and applied principles relevant to clinical embryology. Although these programs have filled a significant gap in learning for established clinical embryologists, they are not appropriate for preparing basic science graduates for entry into the discipline. Moreover, a hallmark of a profession, particularly those related to health care, is the completion of a specifically targeted formal degree or training program required for entry into the profession. With growing recognition of the role of the clinical embryologist in the treatment of infertility, representative clinical embryologists from 20 countries met in Antalya, Turkey, in 2014 with the goal of arriving at a consensus framework to guide fundamental issues in defining the clinical embryologist as a health care professional (Alpha consensus meeting) (11Alpha Scientists in Reproductive MedicineThe Alpha Consensus Meeting on the professional status of the clinical embryologist: proceedings of an expert meeting.Reprod Biomed Online. 2015; 30: 451-461Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar). Chief among these issues was the recommended education and training required to function as a practicing clinical embryologist. The emphasis on practical but informal technical training was acknowledged as a limitation in several training programs, with the members noting “a true understanding of technology requires an understanding of the underlying biologic system, and knowledge of both is critical for effective troubleshooting” (in the article by Alpha Scientists in Reproductive Medicine (11Alpha Scientists in Reproductive MedicineThe Alpha Consensus Meeting on the professional status of the clinical embryologist: proceedings of an expert meeting.Reprod Biomed Online. 2015; 30: 451-461Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar), page 457). The daily tasks completed by clinical embryologists can be generalized to the following: manipulation of gametes and embryos on stereomicroscopes (including oocyte embryo and and of gametes and embryos for and and of gametes and embryo They in quality and risk management and laboratory and of Clinical embryologists are with communicating and with patients and other health care and in regarding care, these tasks to more embryologists or those in a clinical embryologists to that the laboratory clinical laboratory requirements, new technologies and into the training of new new and or in quality or research the of these the consensus at the 2014 Alpha (11Alpha Scientists in Reproductive MedicineThe Alpha Consensus Meeting on the professional status of the clinical embryologist: proceedings of an expert meeting.Reprod Biomed Online. 2015; 30: 451-461Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar), and the Canadian Fertility and Andrology professional competencies Fertility Andrology guidelines for ART laboratory professionals in Scholar), we roles by a professional clinical embryologist. to as these competencies were adopted from the CanMEDs with of the of and of Canada of and of Scholar). competencies Clinical Embryology Laboratory Scholar, and which and are by The curriculum for a professional clinical embryologist training program support the development of these competencies and provide the for the to to in these in the As with these competencies can be in curriculum for continuing professional development and Clinical Laboratory to both and practical knowledge for the of for laboratory procedures. This the ability to the most appropriate laboratory and in a and the of a in aspects of laboratory a to and the ability to professional in the of of when to is to and Moreover, there be a to and of a recognition and management of ethical knowledge of and to requirements, and of professional of and to the of information and that are and This the to information to patients and their and that and are and on to the to function as a of a professional team working to provide the health care for the This and communicating with and other health care professionals and and The clinical embryologist be to to and in a that to the for to remain of This critical to new knowledge appropriately and in research or quality laboratory or of care. The clinical embryologist the principles of research and and role in for health care. to the ability to health and for in for those who are most This responsible The clinical embryologist be of ethical issues and dilemmas within the field and issues are to the ability to with to a of a health care and assume responsibility for in the laboratory This the ability to the science of quality to laboratory patient (including and to and future care, and as a role model for other clinical embryologists and laboratory with a to special the Alpha was on the of a clinical embryologist, they not provide a for and clinical knowledge important for clinical embryologists is in the field of reproductive In many this expertise in or is with the Department of Obstetrics and Gynecology. Reproductive reproductive and physiology, embryo and development, and of health and reproductive and Many graduate degree programs in reproductive are with several programs relevant to clinical embryologists P. R. M. et the educational the of of science programs in reproductive science and 2022; PubMed Scopus Google are to the clinical of embryology. The with the of Obstetrics and Gynecology and Reproductive Sciences are research that are not to the and regulations for the of a clinical laboratory. Importantly, in Canada and many ART clinics and have from to the Thus, those with knowledge in clinical embryology not have the and those in educational not have the the and of clinical within the clinical of laboratory Thus, the expertise within the Department of Obstetrics and Gynecology with that of Clinical Laboratory Medicine provide support for a training program for clinical However, to knowledge, of Clinical Laboratory Medicine have not clinical embryology as a of laboratory and educational programs in clinical embryology have been through these of the of Reproductive and within the Department of Obstetrics and Gynecology at the University of an and need to have a formal graduate training program in a Canadian university to ensure that IVF clinics have clinical embryologists with a to meet the current and future demands of this profession. ART laboratory members to clinic clinical members of the of Obstetrics and Gynecology have sufficient understanding of clinical laboratory to develop a robust educational program in clinical embryology. In a unique development, members of the Department of Obstetrics and Gynecology at the University of with the Department to clinical embryology as a field of within a 2-year professional graduate program in laboratory The Laboratory Medicine program education toward of clinical laboratory or clinical embryologist. with and function as of these laboratory professionals and prepare for within a or laboratory. Although perhaps as an at first there is a and for aspects in the training of these laboratory knowledge of the of laboratory quality molecular biology, critical and Consequently, there are within the The the the unique features of this program as it to the clinical embryology and the by this unique In the curriculum for this the learning and in as recommended by the of the on educational and the following: and of research and of professional and address aspects of the CanEMB competencies for clinical embryologists The curriculum is delivered and full years to The program requires to to a are between the and clinical embryologist are to or clinical embryologists of the of Reproductive and and Reproductive Sciences within the Department of Obstetrics and Gynecology and and basic to the in this which is through the graduate of the The in Laboratory the of the unique which the fields a laboratory The goal of the program is to provide education that general knowledge in laboratory and and applied principles and of or ART clinical that will enable to function as professional laboratory to the Masters of Health Sciences in Laboratory clinical embryology of with and competencies and Laboratory Laboratory Reproductive Embryology and Laboratory Laboratory in in in and of in Laboratory Skills Development Skills Development ART Laboratory Laboratory Laboratory assisted reproductive clinical The of with and in a new ART assisted reproductive clinical embryology. The curriculum with and of This is on and applied in later between theory and through applied emphasis is on and laboratory training, and a research capstone The emphasis on and critical provides for learning and to the development of critical The the program are in along with the or in which they are in the program as as the CanEMB competencies they are by in both the and clinical embryology fields and between the and provides with a understanding of cell biology and This provides fundamental knowledge that is to prepare for later including Reproductive and practical knowledge the research in and the The to various research and they to and laboratory The ability to and research and appropriately research to their and is practical in a review and of a research principles are in the The the appropriate of various and their and their understanding of basic principles is for of their knowledge of research and in a capstone research The is designed to a research in which of the knowledge in the is applied to a research important to the field. are to a research through in their or with various research is with a research that the research with the relevant research and to be and impact of the the a in with guidelines and their to the Although not a of the several of these have been at national As the capstone to the of the and the ability of graduates to for particularly at clinics with The along with in the field are and Clinical Laboratory The in these is to both issues in the field of ART as applied to both research and daily clinical care. to these issues is a for the practicing clinical embryologist and their in and the of and these are in the Clinical Laboratory which quality and laboratory and for clinical laboratory to clinical embryologists Reproductive Embryology and and Reproductive provide the of knowledge and for the field and with on advanced The and principles in these as as the are by on underlying the development and of current and IVF laboratory are in in ART and in In in ART a developments and needs that will the field in in and of provides an into the of and and infertility and the various that can be in their from this of is and in the context of ART team in ART Laboratory The role of the clinical embryologist requires a of technical and with these technical are to the effective training of clinical embryologists and have the framework for the apprenticeship training model widely Although can this working in ART it is provided when laboratory have and risk for patient gametes and embryos to be training. Moreover, to in a practicing laboratory training the ability of the laboratory to clinical care. The Clinical Embryology Skills Development Laboratory is a laboratory to a IVF laboratory environment a environment for to with basic and a in the gametes and embryos from model and human The is into general and required by the clinical embryologist for the laboratory of ART and and oocyte and embryo and embryo and and including and embryo Thus, the provides a biologic environment can and of patient care or the general of a working ART laboratory. this provide the with sufficient to enable to as clinical clinical embryologists will with documented successes to and for However, the provide the to enable the to through training programs integral to established ART The the for continued professional development of working clinical embryologists through the ability to and certification designed for training or a placement in their to on in the and provide the to be in the and of a practicing ART laboratory. In this the a of a in practicing ART they with the daily and demands of an IVF laboratory. Although the of their is in the IVF they in the which the IVF laboratory in and these are to a who and that they and with fundamental tasks that not on the legal of the can be the laboratory laboratory or who is charged with training new and have an at the The are to to basic laboratory human gametes and which they are generally to the in the Moreover, into the laboratory team they their in and have in both and IVF with in a at a the placement meet regularly with to their ensure that are and provide as to be and daily to and In and meet with the directors of the placement on a to and To the the placement directors meet regularly with laboratory directors and to ensure in the of the procedures. through these various both within their clinic and in with from are to to their professional Although a we have recently first of who as practicing clinical embryologists in ART The program a significant of that has first years of for in and were and In a of is with the of the of of or the years of their baccalaureate degree from an In to of of in the program and as is as and for learning A. The of the embryologist to a IVF system: an Fertil Soc Scopus Google Scholar). and programs the learning needs for individuals to become clinical embryologists are required for to be as The program unique features to the clinical embryology field. is the formal of clinical embryology into the of an with several and practical aspects of the education delivered through the of the members of the Department of Obstetrics and Gynecology. This recognition of clinical embryology by the laboratory provides the field with an appropriate but that and requires continued partnership with and is the of a laboratory that is to provide a IVF laboratory that provides a environment for to and with and laboratory procedures. is the of an ART laboratory placement into the educational program that on the in the to the of a ART laboratory. important for this and degree programs will be formal of the program as an appropriate curriculum and for clinical a of and of a rigorous educational program that or the needs of the profession. with the of clinical embryology training programs and the recognition of clinical embryologists as true professionals, an is not in The for Clinical Laboratory Sciences in the United States provides for training programs in clinical laboratory including This has that it to their laboratory science to clinical embryology in the The of the Masters of Health Sciences in Laboratory clinical embryology field specialization was by a team of individuals who contributed to the development of the to the are and The of the Department of Obstetrics and who provided and and and for their in the The and S. for the development and of the Masters of Health Sciences and recognition of clinical embryologists as but does the future with interest the by et of the clinical embryology laboratory development of a novel program delivered in a laboratory The a 2-year program that they established recently at the University of in the Department of Clinical Medicine in collaboration with the Department of Obstetrics and Gynecology. The curriculum for this program was developed with from the of that of educational and and of research and of professional and PDF

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.