探讨卵子玻璃化冷冻的临床应用可行性。

选择2011年7月至2016年5月，于江苏省苏北人民医院生殖医学中心采用玻璃化冷冻技术保存的卵子，进行卵母细胞胞质内单精子注射(ICSI)的13例患者，共计15个冷冻卵子ICSI周期为研究对象，纳入冷冻卵子组。选择同期于本院生殖医学中心进行新鲜卵子ICSI的252例患者，共计288个新鲜卵子ICSI周期作为对照，纳入新鲜卵子组。回顾性分析2组ICSI周期的临床病例资料，统计学比较2组受试者一般临床资料，受精情况及胚胎质量，以及临床妊娠结局。本研究遵循的程序符合江苏省苏北人民医院人体试验委员会制定的伦理学标准，得到该委员会批准，分组征得受试者知情同意，并与之签署临床研究知情同意书。

①2组患者的年龄、不孕年限、人体质量指数(BMI)、ICSI卵子数比较，差异均无统计学差异(P>0.05)。②冷冻卵子组中，卵子解冻后复苏存活率为87.1%(108/124)。冷冻卵子组卵裂率、优质胚胎率，均较新鲜卵子组显著降低，2组卵裂率与优质胚胎率分别为89.0%比98.2%与35.4%比50.7%，2组比较，差异均有统计学意义(χ²＝27.274，P<0.001；χ²＝5.871，P＝0.016)。2组正常受精率、可利用胚胎率比较，差异均无统计学意义(P>0.05)。③2组平均移植胚胎数比较，差异无统计学意义(P＝0.822)。冷冻卵子组体外受精-胚胎移植(IVF-ET)周期的胚胎种植率、活产率，均显著低于新鲜卵子组IVF-ET周期，并且差异均有统计学意义(χ²＝5.534，P＝0.017；χ²＝7.005，P＝0.011)；2组IVF-ET周期的临床妊娠率、自然流产率分别比较，差异均无统计学意义(P>0.05)。

卵子玻璃化冷冻、解冻后，再进行IVF-ET，可获得一定临床妊娠率，但卵子玻璃化冷冻技术仍会对卵子质量产生影响，进而影响胚胎质量和临床妊娠结局，此技术有待进一步改善。因本研究纳入样本量相对较小，卵子玻璃化冷冻技术保存的有效性，仍有待多中心、大样本、随机对照研究进一步证实。

To explore the possibility of clinical application of oocyte vitrification.

From July 2011 to May 2016, a total of 15 intracytoplasmic sperm injection (ICSI) cycles with oocytes preserved by vitrification among 13 patients in Reproductive Medicine Center, Northern Jiangsu People′s Hospital were chosen as study subjects, and they were enrolled into frozen oocyte group. And 288 ICSI cycles by fresh oocytes among 252 patients during the same period in the same hospital were chosen as contrast, and they were enrolled into fresh oocyte group. The clinical data of two groups were retrospectively analyzed. And the general clinical data, fertilization rate, embryo quality and clinical pregnancy outcomes between two groups were compared by statistical methods. The study protocol was approved by the Ethical Review Board of Investigation in Human Beings of Northern Jiangsu People′s Hospital. Informed consent was signed by each participant.

①There were no statistical differences between two groups in general clinical data, including age, duration of infertility, body mass index (BMI), number of ICSI oocytes (P>0.05). ②The survival rate of frozen-thawed oocytes in frozen oocyte group was 87.1% (108/124). The rates of cleavage and high-quality embryo in frozen oocyte group both were lower than those in fresh oocyte group, which were 89.0% vs 98.2%, and 35.4% vs 50.7%, respectively, and both the differences were statistically significant (χ²=27.274, P<0.001; χ²=5.871, P=0.016). There were no significant differences between two groups in the rates of normal fertilization and available embryo (P>0.05). ③There was no statistical difference between two groups in the average number of embryos transferred (P=0.822). The rates of embryos implantation and live birth of in vitro fertilization-embryo transfer (IVF-ET) cycles in frozen oocyte group both were statistically lower than those in fresh oocyte group, and both the differences were statistically significant (χ²=5.534, P=0.017; χ²=7.005, P=0.011). While there were no statistical differences between two groups in the rates of clinical pregnancy and abortion of IVF-ET cycles (P>0.05).

Frozen-thawn oocytes vitrification of IVF-ET can obtain a certain clinical pregnancy rate. But vitrification also has negative influences on oocytes, and thus influencing the qualities of embryos and clinical pregnancy outcomes which needs to be improved. As the sample size in this study is relatively small, the effectiveness of oocyte vitrification still needs multi-center, large-sample and randomized control study to confirm.