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比较经欧洲和北美使用戈那瑞林或重组卵泡刺激素促排卵后活产率和累计持续妊娠率。

A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone.

机构信息

Huntington Reproductive Center, Encino, California 91436, USA.

出版信息

Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28.

DOI:10.1016/j.fertnstert.2012.02.038
PMID:22459628
Abstract

OBJECTIVE

To compare live birth rates after fresh embryo transfer (ET) and cumulative ongoing pregnancy rates after fresh ET and frozen-thawed (ET) between continents and overall after one treatment cycle with corifollitropin alfa or recombinant FSH.

DESIGN

Double-blind, multicenter, randomized controlled trial.

SETTING

Fourteen centers in North America (NA); 20 in Europe (EU).

PATIENT(S): 804 NA patients and 702 EU patients.

INTERVENTION(S): Patients >60 kg received a single dose of corifollitropin alfa or daily rFSH for the first 7 days of controlled ovarian stimulation.

MAIN OUTCOME MEASURE(S): Live birth rates.

RESULT(S): Within each continent no differences were noted between the two treatment groups; however, between continents, the cumulative ongoing pregnancy rate and live birth rate were considerably higher in NA than in EU. The live birth rate in NA was 39.2% in both treatment groups compared with 31.5% and 28.8% in EU after corifollitropin alfa and rFSH treatment, respectively. Considering the number of embryos transferred, the live birth rate per ET was still higher in NA than in EU (42.7% v.s 36.8% with corifollitropin alfa and 41.6% vs. 30.9% with rFSH). Overall live birth rates after fresh ET were 35.6% and 34.4% (estimated difference 1.1% [95% confidence interval -3.7-5.8]), and the estimated cumulative live birth rates were 43.4% and 41.3% with corifollitropin alfa and rFSH, respectively.

CONCLUSION(S): Live birth rates and cumulative pregnancy rates were higher in NA than in EU after treatment with either corifollitropin alfa or daily rFSH; both treatment protocols provided equal success rates. CLINICALTRIALS.GOV IDENTIFIERS: NCT00703014 and NCT00702273.

摘要

目的

比较在新鲜胚胎移植(ET)后活产率和新鲜 ET 与冻融 ET 后累积持续妊娠率,并比较使用戈那瑞林或重组 FSH 进行一次治疗周期后的全球活产率。

设计

双盲、多中心、随机对照试验。

地点

北美 14 个中心(NA);欧洲 20 个中心(EU)。

患者

804 名 NA 患者和 702 名 EU 患者。

干预

体重 >60kg 的患者接受戈那瑞林或重组 FSH 单次剂量,用于控制性卵巢刺激的前 7 天。

主要观察指标

活产率。

结果

在每个大陆内,两组治疗之间没有差异;然而,在大陆之间,NA 的累积持续妊娠率和活产率明显高于 EU。在戈那瑞林和重组 FSH 治疗组中,NA 的活产率分别为 39.2%和 31.5%、28.8%。考虑到移植胚胎的数量,NA 的每个 ET 活产率仍高于 EU(戈那瑞林组为 42.7%,重组 FSH 组为 41.6%)。新鲜 ET 后活产率分别为 35.6%和 34.4%(估计差值为 1.1%[-3.7 至 5.8]),戈那瑞林和重组 FSH 的累积活产率分别为 43.4%和 41.3%。

结论

在使用戈那瑞林或重组 FSH 治疗后,NA 的活产率和累积妊娠率高于 EU;两种治疗方案均具有相同的成功率。

临床试验注册号

NCT00703014 和 NCT00702273。

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