Yao Zhan, Vansteelandt Stijn, Van der Elst Josiane, Coetsier Tom, Dhont Marc, De Sutter Petra
Department of Obstetrics and Gynaecology, Ghent University, De Pintelaan 185, B-9000 Gent, Belgium.
Hum Reprod. 2009 Apr;24(4):880-7. doi: 10.1093/humrep/den453. Epub 2008 Dec 18.
Embryo transfer is a crucial step in the IVF process. Most randomized prospective studies comparing transfer catheters have demonstrated significantly higher pregnancy rates with soft versus firm catheters, but none have taken the operator effect into account. Our aim was to perform a prospective randomized clinical trial comparing two catheters and to study interactions between catheters and operators.
A prospective randomized trial comparing the Cook K-SOFT-5100 and Frydman classical catheters 4.5 was performed. Three experienced operators participated in the trial, using a fixed distance transfer protocol. Primary end-point was clinical pregnancy rate, secondary end-points were rates of difficult transfer and of catheter failure. Patients were randomized by a computer program prior to embryo transfer.
A total of 1446 embryo transfers were performed in 1155 women undergoing IVF or ICSI treatment. A total of 723 cycles were randomized to the Cook catheter and 723 cycles to the Frydman catheter. Following intention-to-treat analysis, the adjusted odds ratio of clinical pregnancy between for the Cook versus the Frydman catheter was 1.11 [95% confidence interval (95% CI) 0.89-1.38]. Odds ratios of clinical pregnancy between the Cook and Frydman catheters for the three operators were respectively 1.19 (95% CI 0.84-1.69), 2.35 (95% CI 1.40-3.95) and 0.69 (95% CI 0.48-0.99).
Variation in pregnancy rates between embryo transfer catheters depends on variation between operators. Results from randomized clinical trials comparing embryo transfer catheters should not be generalized, because inconsistent conclusions may be unavoidable on the account of different proportions of cycles with transfers by each type of operator. The study was registered at clinicaltrials.gov. NCT00766714.
胚胎移植是体外受精（IVF）过程中的关键步骤。大多数比较移植导管的随机前瞻性研究表明，与硬导管相比，软导管的妊娠率显著更高，但均未考虑操作者的影响。我们的目的是进行一项前瞻性随机临床试验，比较两种导管，并研究导管与操作者之间的相互作用。
进行了一项前瞻性随机试验，比较库克K-SOFT-5100导管和弗莱德曼经典4.5导管。三名经验丰富的操作者参与了试验，采用固定距离移植方案。主要终点是临床妊娠率，次要终点是困难移植率和导管失败率。患者在胚胎移植前通过计算机程序进行随机分组。
1155名接受IVF或卵胞浆内单精子注射（ICSI）治疗的女性共进行了1446次胚胎移植。共有723个周期被随机分配至库克导管组，723个周期被随机分配至弗莱德曼导管组。在意向性分析之后，库克导管与弗莱德曼导管相比，临床妊娠的校正优势比为1.11[95%置信区间（95%CI）0.89 - 1.38]。三名操作者使用库克导管和弗莱德曼导管时临床妊娠的优势比分别为1.19（95%CI 0.84 - 1.69）、2.35（95%CI 1.40 - 3.95）和0.69（95%CI 0.48 - 0.99）。
胚胎移植导管之间妊娠率的差异取决于操作者之间的差异。比较胚胎移植导管的随机临床试验结果不应一概而论，因为由于不同类型操作者进行移植的周期比例不同，得出不一致的结论可能是不可避免的。该研究已在clinicaltrials.gov注册。NCT00766714。
