Ata Baris, Isiklar Aycan, Balaban Basak, Urman Bulent
The Assisted Reproduction Unit, American Hospital of Istanbul, Turkey.
Reprod Biomed Online. 2007 Apr;14(4):471-6. doi: 10.1016/s1472-6483(10)60895-4.
The aim of this study was to compare the clinical performance of Wallace and Labotect embryo transfer catheters in a single assisted reproduction centre. A total of 260 women undergoing embryo transfer were randomized between Wallace and Labotect catheters. When both catheters failed to negotiate the cervical canal, the transfer was accomplished with a stiff catheter. Intention to treat analysis revealed that Wallace and Labotect embryo transfer catheters yielded statistically similar clinical pregnancy (44.6 versus 34.6%), implantation (23.2 versus 18.9%) and ongoing pregnancy (38.5 versus 27.7%) rates. As treated analysis revealed clinical pregnancy rates of 42.5 versus 35.4%, implantation rates of 22.3 versus 20.6% and ongoing pregnancy rates of 36.8 versus 28.3% with Wallace and Labotect catheters respectively. Catheter change due to unsuccessful negotiation of the internal cervical os was significantly more frequently necessary when embryo transfer was first intended with the Wallace than the Labotect catheter (P < 0.001; 33 and 2% respectively). Although not being statistically significant, the observed differences may be regarded as clinically important and may reach statistical significance in larger trials. More trials are necessary before reaching a definitive conclusion regarding the performance of the Labotect embryo transfer catheter.
本研究的目的是在单一辅助生殖中心比较华莱士（Wallace）和拉博泰克（Labotect）胚胎移植导管的临床性能。共有260名接受胚胎移植的女性被随机分配使用华莱士导管和拉博泰克导管。当两种导管均无法通过宫颈管时，则使用硬导管完成移植。意向性分析显示，华莱士和拉博泰克胚胎移植导管在临床妊娠率（44.6%对34.6%）、着床率（23.2%对18.9%）和持续妊娠率（38.5%对27.7%）方面在统计学上相似。实际治疗分析显示，使用华莱士和拉博泰克导管的临床妊娠率分别为42.5%对35.4%，着床率分别为22.3%对20.6%，持续妊娠率分别为36.8%对28.3%。当首次打算使用华莱士导管而非拉博泰克导管进行胚胎移植时，因未能成功通过宫颈内口而更换导管的情况明显更为常见（P<0.001；分别为33%和2%）。尽管差异无统计学意义，但观察到的差异可能被视为具有临床重要性，并且可能在更大规模的试验中达到统计学意义。在就拉博泰克胚胎移植导管的性能得出明确结论之前，还需要进行更多试验。
