Mouse embryo assay for human in vitro fertilization quality control: a fresh look.

The mouse embryo assay (MEA) has been used in the field of human in vitro fertilization (IVF) for multiple purposes such as developing embryo culture media, quality control within the laboratory, and procedural training and proficiency testing for embryology staff. In addition, manufacturing companies use the MEA as a means of quality control for the development of embryo culture media and medical devices and to meet the standards of testing for FDA approval of new products. It has long been considered by embryologists and laboratory scientists whether the MEA is an accurate or sensitive test in the quality assessment of culture media and medical devices or if use of this testing is more an obligation. There is no uniformly accepted gold standard method for IVF lab quality control or FDA approval. This review aims to revisit the role of the use of mouse embryos in the formulation of IVF media for clinical use and the different methods of employing the mouse embryo assay for quality control. In addition, we will review the use of the MEA as an important adjunct in the training for embryology staff and fellows in training in reproductive endocrinology and infertility (REI), as well as alternatives to the use of the MEA for these purposes.