Research question

An evidence-based novel commercially available continuous IVF culture medium in compliance with an efficient quality-management system is proposed.

Design

Non-interventional study on sibling oocytes. Intracytoplasmic sperm injection cycles among women aged 42 years or younger that used ejaculated spermatozoa and retrieved four to eight oocytes were included. Sibling oocytes were randomized for culture in the novel Geri-medium or continuous single culture medium (CSCM). Primary outcome measure was blastulation rate per cohort of inseminated oocytes; 1182 oocytes were required to outline down to a 7% difference (power = 80%).

Results

A total of 181 cohorts of sibling oocytes were included. Geri-medium (n = 631 oocytes) and CSCM (n = 643 oocytes) resulted in similar blastulation rates (mean ± SD: 42.8% ± 30.1% versus 43.1% ± 29.0%; Wilcoxon signed rank test = 0.77). Blastocysts cultured in the former (n = 275 versus n = 277) showed longer timings during preimplantation development (P < 0.01) and were poorer quality (26% versus 18%; P = 0.03). Euploidy rate was no different in cycles that underwent preimplantation genetic testing for aneuploidy (n = 113) (117/237 [49%] versus 117/249 blastocysts [47%]; P = 0.6). Ongoing implantation rate was comparable in the study arms after euploid (29/47 [63%] versus 14/ 34 [41%]; P = 0.1) or untested (12/31 [39%] versus 7/18 [39%]; P = 0.3) transfers.

Conclusion

Blastulation rate among cohorts of sibling oocytes cultured in the same incubator is a fast, reliable and comprehensive performance indicator to validate novel commercially available culture medium. The media tested were considered similarly efficient. The differences in blastocyst morphology and developmental timings warrant further investigation, although euploidy and ongoing implantation rates were similar.

中文翻译：

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两种 IVF 培养基中同胞卵母细胞的爆破率：实施新商业化产品的循证工作流程

研究问题

提出了一种符合有效质量管理体系的循证新型商业连续试管婴儿培养基。

设计

同胞卵母细胞的非干预性研究。包括使用射出的精子并取回 4 到 8 个卵母细胞的 42 岁或以下女性的卵胞浆内单精子注射周期。同胞卵母细胞随机培养在新型 Geri 培养基或连续单一培养基 (CSCM) 中。主要结果指标是每组受精卵母细胞的成胚率；需要 1182 个卵母细胞来勾勒出 7% 的差异（功率 = 80%）。

结果

共包括 181 组同胞卵母细胞。Geri-medium ( n  = 631 个卵母细胞) 和 CSCM ( n  = 643 个卵母细胞) 导致相似的成胚率（平均值 ± SD：42.8% ± 30.1% 对 43.1% ± 29.0%；Wilcoxon 符号秩检验 = 0.77）。在前者中培养的囊胚（n  = 275 vs n  = 277）在植入前发育期间显示出更长的时间（P < 0.01）并且质量较差（26% vs 18%；P  = 0.03）。在接受非整倍体植入前基因检测的周期中，整倍体率没有差异（n  = 113）（117/237 [49%] 对 117/249 个囊胚 [47%]；P = 0.6）。整倍体（29/47 [63%] 与 14/ 34 [41%]；P  = 0.1）或未经测试（12/31 [39%] 与 7/18 [39%]）后研究组的持续植入率相当; P  = 0.3) 转移。

结论

在同一孵化器中培养的同胞卵母细胞群体之间的爆破率是一种快速、可靠和全面的性能指标，可用于验证新型市售培养基。测试的介质被认为具有类似的效率。尽管整倍体和持续着床率相似，但囊胚形态和发育时间的差异值得进一步研究。