Safety, Efficacy, and Complexities in the ART Laboratory

The awarding of the 2010 Nobel Prize in Medicine to Dr. Robert G. Edwards brought profound acknowledgment of the far-reaching depth and breadth of Dr. Edwards's contributions to the development of in vitro fertilization (IVF). Indeed, >4 million babies have now been born with the use of IVF and its related procedures. In the 34 years since the birth of Louise Brown, the first IVF baby, numerous advances have been made in the field, resulting in new and emerging technologies and areas of investigation involving broad collaborations among diverse scientific and medical specialties. Not only are success rates from IVF continuing to increase, but a steadily increasing number of patients with unique reproductive challenges are being helped in their quest to create and build healthy families. These are, indeed, exciting times in the field of assisted reproductive technology (ART). Yet the speed at which new ART technologies are being introduced, along with the complexities associated with existing technologies, demand an ever-increasing imperative focused on ensuring maintenance of patient identity and safety of tissues at all costs.

The objectives of this issue are first and foremost to consider the complexities of running an ART laboratory with the many and varied challenges associated with maintaining patient safety and optimizing laboratory care through the application of standardized operating procedures, the use of checklists, and the implementation of quality control and quality assurance protocols. The second objective of this volume is to appraise the current status of some of the more established ART procedures, as well as to present key current topics that hold promise either in broad application of improved care in general, or in particular, as more directed approaches for uniquely challenging cases.

This issue begins with a physician's commentary by Dr. Bill Gibbons on the shared responsibility of all ART team members to communicate honestly among themselves and with their patients, and to require open disclosure at every treatment stage. Few, if any other, medical therapy requires administration of patient care by such varied specialists including gynecologists, reproductive endocrinologists, urologists, andrologists, embryologists, nurses, and therapists. Continuous communication among all members of this diverse team presents unique challenges and is of paramount importance to ensure that the safest and most effective therapies are provided. We therefore focused this commentary on the management of medical errors in the complex ART environment and the various approaches to reducing medical errors and risk-producing unnecessary complexities, including the central roles of patient informed consent and understanding of ART laboratory practices by clinical team members, who is too often unaware of what goes on in the IVF laboratory.

This overview is followed by several articles focused on operating procedures in the ART laboratory. This series includes consideration of the issues relating to patient and tissue identification, and the use of checklists, the importance of materials supply integrity and quality control and quality assurance protocols in the ART laboratory, and an appraisal of regulations (from Europe) for improving the quality of ART laboratory performance. Articles then follow that consider evidence-based emerging treatment options including the current status of in vitro maturation of oocytes, advances in embryo culture systems, whether embryos should be transferred on day 2, the relative benefits of transferring embryos fresh or after thawing/warming, the developing technology of comprehensive chromosome screening for improved embryo selection with the strong potential of increasing application of single embryo transfer, and an in-depth consideration of tailored approaches more appropriate for uniquely challenging cases including cellular, molecular, and genetic analyses of gametes.

It has been our pleasure, as co-editors of this special ART laboratory edition of Seminars of Reproductive Medicine, to work together with the group of experts who have contributed to the topics discussed here. We hope that the result is an informative volume of interest to all health-care specialists involved in the clinical evaluation and treatment of an infertile couple. Perhaps more importantly, we hope that this volume will inspire ever more rigorous attention to the highest possible standards of safety and quality of care in treating the ART patient. As concluded by Dr. Gibbons in his commentary, “Errors in this environment are poorly tolerated. In practice, the fact that monumental errors are rare speaks to the training, dedication, and skill provided by the large number of disciplines involved.”