Reproductive Medicine Unit- GynePro Medical Centers, GynePro Medical, Via T. Cremona, 8 -, 40137, Bologna, Italy.
NextClinics International, Aystetten, Germany.
J Assist Reprod Genet. 2020 Jun;37(6):1379-1385. doi: 10.1007/s10815-020-01798-3. Epub 2020 May 3.
To investigate the clinical efficacy of a "Universal Warming" protocol, based on subsequent steps with 1 M and 0.5 M concentration of extracellular cryoprotectant (ECCP), on shipped oocytes. Oocytes are vitrified using different brands of ready-to-use kits which recommend that the use of their own warming kit and combining different vitrification/warming kits may have legal consequences for assisted reproductive (AR) centers, until this practice has been validated with clinical studies.
Retrospective multi-center transnational observational study. Number of oocytes warmed 1.898. Vitrification performed with vitrification kit (Kitazato, Japan); warming carried out randomly with two different kits: Kitazato warming kit and Vit Kit®-Thaw (FujiFilm Irvine, USA). Warmed oocytes were assigned to 2 groups: KK (Kitazato/Kitazato) 939, and KI (Kitazato/Irvine) 959. Primary endpoint: survival rate. Secondary endpoints: fertilization rate; blastulation rate; implantation rate; live birth rate.
Survival was comparable between the groups: 84.6% (795/939) in group KK vs 82.1% (787/959) in group KI. Fertilization rate was lower (P = 0.027) in group KK (75.7%-602/795) than in group KI (80.4%-633/787). Blastulation and implantation and live birth rates were all statistically comparable between the study groups: blastulation rate was 58.5% (352/602) vs 57.8% (366/633); implantation rate was 41.5% (80/193) vs 45.9% (84/183); live birth rate was 52.5% (62/118) in KK and 45.0% (54/120) in KI.
The use of this "Universal Warming" protocol simplifies vitrified oocyte exchange between AR centers in different countries, and overcomes potential regulatory/commercial/availability differences affecting clinical practice.
研究基于后续步骤中使用 1M 和 0.5M 浓度细胞外冷冻保护剂（ECCP）的“通用升温”方案对运输卵母细胞的临床疗效。卵母细胞使用不同品牌的即用型试剂盒进行玻璃化，这些试剂盒建议使用自己的升温试剂盒，并且混合使用不同的玻璃化/升温试剂盒可能会对辅助生殖（AR）中心产生法律后果，直到该操作通过临床研究得到验证。
回顾性多中心跨国观察性研究。解冻的卵母细胞数量为 1898 个。使用玻璃化试剂盒（日本北里）进行玻璃化处理；随机使用两种不同的试剂盒进行升温：北里升温试剂盒和 Vit Kit®-Thaw（美国富士胶片欧文）。解冻后的卵母细胞被分为 2 组：KK（北里/北里）939 个，KI（北里/欧文）959 个。主要终点：存活率。次要终点：受精率；卵裂率；囊胚形成率；活产率。
两组之间的存活率相当：KK 组为 84.6%（795/939），KI 组为 82.1%（787/959）。KK 组的受精率较低（P=0.027）（75.7%-602/795），而 KI 组为 80.4%-633/787）。囊胚形成率、着床率和活产率在研究组之间均具有统计学可比性：囊胚形成率为 58.5%（352/602）和 57.8%（366/633）；着床率为 41.5%（80/193）和 45.9%（84/183）；活产率为 KK 组 52.5%（62/118）和 KI 组 45.0%（54/120）。
使用这种“通用升温”方案简化了不同国家 AR 中心之间运输卵母细胞的交换，克服了影响临床实践的潜在监管/商业/可用性差异。
