The effects of glutamine supplementation on the blastocoele formation and hatching of mouse preimplantation embryos were investigated. When culturing the 1-cell or 2-cell stage embryos in glutamine-supplemented media, the incidence of development to each stage from the morula stage to the completely hatched blastocyst stage was higher than for culturing in media without glutamine supplementation. When culturing 4-cell stage, 8-cell stage or morula stage embryos in glutamine-supplemented media, percentage of development up to the expanded blastocyst stage was comparable to culturing in media without glutamine supplementation, but the hatching rate for the glutamine-supplemented media was higher or tended to be higher compared to culturing in media without glutamine supplementation. Further, culturing in glutamine-supplemented media from the early blastocyst stage, the blastocyst stage or the expanded blastocyst stage resulted in a higher hatching rate compared to culturing in media without glutamine supplementation. These findings suggest that culturing in glutamine-supplemented media before the 2-cell stage, leads to improvements not only in the rates of morula formation and blastocoele formation, but also the rate of hatching. Further, efficient usage of glutamine appears to be elevated during the course of hatching.

In the United States, assisted reproduction devices are categorized as “medical devices” and regulated by FDA. Most of assisted reproduction devices are classified in Class II based on level of control necessary to assure the safety and effectiveness as well as on risk to patient and/or user. Manufactures must submit a 510(k) to FDA before introducing a device to the U. S. market. Assisted Reproduction devices should be manufactured in accordance with Good Manufacturing Practice (GMP) and manufactures must demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. The status of regulations and the contents required to applicants in the U. S. are reported.