Drakeley Andrew J, Jorgensen Andrea, Sklavounos John, Aust Thomas, Gazvani Rafet, Williamson Paula, Kingsland Charles R
Hewitt Centre for Reproductive Medicine, Liverpool Women's Hospital NHS Foundation Trust, Crown Street, Liverpool L8 7SS, UK.
Hum Reprod. 2008 May;23(5):1101-6. doi: 10.1093/humrep/den064. Epub 2008 Mar 5.
We wanted to test the hypothesis that using abdominal ultrasound at the time of embryo transfer to guide replacement, improved pregnancy rates by at least 5%.
An RCT in a large assisted conception unit. A pilot study and power calculation suggested that at least 2000 embryo transfers were required to demonstrate a difference of 5%, for a test with 80% power and Type 1 error 0.05. Randomization, data entry and analysis were arranged independently. Randomization was stratified for age and fresh/frozen embryo transfer. Analysis was by intention to treat.
There was no difference in clinical pregnancy or live birth rates between the two groups. The clinical pregnancy rate for ultrasound-guided embryo transfer was 22% and for non-ultrasound-guided embryo transfer was 23% (odds ratio: 0.96; 95% confidence interval: 0.79-1.18).
We set out to determine whether ultrasound-guided embryo transfer improved clinical pregnancy rates and live birth rates in assisted conception. We used an appropriately powered RCT design. We did not demonstrate a difference. This outcome is at odds with the UKs National Institute of Clinical Excellence recommendations for fertility treatment (Fertility Assessment and Treatment for People with Fertility Problems. London, UK: RCOG Press, 2004, 112.) which used a meta-analysis of four smaller trials (range 362-800 patients, totalling 2051 embryo transfers) to conclude that ultrasound should be offered. We suggest that the current Cochrane review should be updated with data from our trial and recommend that consideration is given to accounting for heterogeneity between the included trials.
我们想要检验这样一个假设，即在胚胎移植时使用腹部超声引导移植，可使妊娠率至少提高5%。
在一个大型辅助生殖中心进行的随机对照试验。一项初步研究和功效计算表明，为了在功效为80%且I型错误为0.05的检验中证明5%的差异，至少需要进行2000次胚胎移植。随机分组、数据录入和分析均独立安排。随机分组按年龄和新鲜/冷冻胚胎移植进行分层。分析采用意向性分析。
两组之间的临床妊娠率或活产率没有差异。超声引导下胚胎移植的临床妊娠率为22%，非超声引导下胚胎移植的临床妊娠率为23%（优势比：0.96；95%置信区间：0.79 - 1.18）。
我们着手确定超声引导下胚胎移植是否能提高辅助生殖中的临床妊娠率和活产率。我们采用了样本量合适的随机对照试验设计。但未证明存在差异。这一结果与英国国家临床优化研究所关于生育治疗的建议（《生育问题人群的生育评估与治疗》。英国伦敦：皇家妇产科学院出版社，2004年，第112页）不一致，该建议通过对四项较小试验（患者数量范围为362 - 800例，共2051次胚胎移植）的荟萃分析得出应使用超声的结论。我们建议用我们试验的数据更新当前的Cochrane系统评价，并建议考虑纳入试验之间的异质性。
