Cell Count of Mouse Blastocyst on Pre-clinical Evaluation of Safety of Medical Devices in Assisted Reproductive Technologies.
10.3969/j.issn.1671-7104.2018.04.017
- Author:
Qianqian HAN
1
;
Junzhao ZHAO
2
;
Zhaopeng YANG
1
;
Jianfeng SHI
1
;
Ying WANG
1
;
Huan LIAN
1
;
Chunren WANG
1
;
Xingliang JIN
2
Author Information
1. Medical Device Control, National Institute of Food and Drug Control, CFDA, Beijing, 102629.
2. Reproductive Medical Center of the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, 325027.
- Publication Type:Journal Article
- Keywords:
assisted reproductive technologies;
blastocyst;
immunofluorescence;
inner cell mass;
medical device
- MeSH:
Animals;
Blastocyst;
Embryonic Development;
Equipment Safety;
Mice;
Reproducibility of Results;
Reproductive Techniques, Assisted;
instrumentation
- From:
Chinese Journal of Medical Instrumentation
2018;42(4):289-292
- CountryChina
- Language:Chinese
-
Abstract:
Various types of medical devices used in assisted reproductive technologies (ART) should be detected for their safety by strict biological assays. Mouse embryo assay(MEA)has been recognized as one of the most important and standardized methods with the threshold more than 80% of blastocyst formation rate (BR) after 96 h culture of fertilized eggs. The disadvantage using BR for embryonic quality control has been concerned as it is ubiquitously dependent of embryonic morphology and the detailed data including molecular and genetic information is obviously missing and incomplete. This leads to the urgent requirement for more sensitive and efficient assessments for the quality control of ART. This study evaluated the reliability of an immunofluorescent MEA by counting total cell and differential number of the cells in the inner cell mass (ICM) and trophectoderm (TE) in the blastocyst. This method improved the traditional MEA, provided a sensitive and powerful platform to assess embryonic developmental viability and should be suggested as a standard assay to be globally used for the quality control of medical devices and pre-clinical procedures in ART.
