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新鲜周期与冷冻周期后 521 例妊娠结局:比较 GnRH 拮抗剂与 GnRH 激动剂方案的随机对照试验的次要结局。

Perinatal outcomes in 521 gestations after fresh and frozen cycles: a secondary outcome of a randomized controlled trial comparing GnRH antagonist versus GnRH agonist protocols.

机构信息

The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Centre of Infertility and Medically Assisted Reproduction, Hospital Garcia de Orta, Almada, Portugal.

The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

出版信息

Reprod Biomed Online. 2019 Oct;39(4):659-664. doi: 10.1016/j.rbmo.2019.05.010. Epub 2019 May 17.

Abstract

RESEARCH QUESTION

Are perinatal outcomes different after treatment with the gonadotrophin-releasing hormone (GnRH) antagonist versus the long GnRH agonist protocol for IVF?

DESIGN

Perinatal outcomes were secondary outcomes in a large Phase IV, dual-centre, open-label, randomized controlled trial to compare GnRH antagonist and long GnRH agonist protocols in women <40 years undergoing their first assisted reproductive technology treatment. Women (n = 1050) were randomized in a ratio 1:1 from January 2009 to December 2013 and followed until December 2016. All fresh and frozen embryo transfer (FET) cycles from a single oocyte aspiration, resulting in a gestation (human chorionic gonadotrophin >10 IU/l) were included (n = 521). Data were analysed to compare preterm birth [PTB] (<37 weeks), very PTB (<32 weeks), low birthweight [LBW] (<2500 g) and very LBW (<1500 g) rates among singleton live births in GnRH antagonist versus agonist protocol.

RESULTS

Similar perinatal outcomes were found after both protocols. In singletons after fresh embryo transfer, mean gestational age at delivery was 39.1 ± 2.49 versus 39.3 ± 1.90 (P = 0.67) and very PTB rates 1.9% versus 0% (P = 0.17). Mean birthweight was 3264 ± 662 g in the antagonist and 3341 ± 562 g in the agonist group (P = 0.37). LBW was found in 12.4% versus 7% (P = 0.19) and very LBW in 2.9% versus 1% (P = 0.34). In FET cycles, the perinatal outcomes were similar. Small for gestational age and large for gestational age rates were similar in both protocols for singleton live births after fresh and FET.

CONCLUSIONS

Perinatal outcomes are similar after the GnRH antagonist versus GnRH agonist protocols for IVF. The choice of the GnRH analogue in ovarian stimulation should be based solely on optimizing the chance of pregnancy and not on risks in perinatal outcomes.

摘要

研究问题

在接受促性腺激素释放激素(GnRH)拮抗剂与长 GnRH 激动剂方案治疗体外受精(IVF)后,围产期结局是否不同?

设计

围产期结局是一项大型四期、双中心、开放标签、随机对照试验的次要结局,该试验旨在比较 GnRH 拮抗剂和长 GnRH 激动剂方案在接受首次辅助生殖技术治疗的<40 岁女性中的应用。2009 年 1 月至 2013 年 12 月,按 1:1 的比例随机分配女性(n=1050),并随访至 2016 年 12 月。所有新鲜和冷冻胚胎移植(FET)周期均来自单次卵母细胞抽吸,妊娠(人绒毛膜促性腺激素>10 IU/l)(n=521)。分析数据以比较 GnRH 拮抗剂与激动剂方案中单胎活产儿的早产(PTB)(<37 周)、极早产(<32 周)、低出生体重(LBW)(<2500 g)和极低出生体重(VLBW)(<1500 g)率。

结果

两种方案的围产期结局相似。新鲜胚胎移植后,单胎的中位分娩孕周分别为 39.1±2.49 周和 39.3±1.90 周(P=0.67),极早产率分别为 1.9%和 0%(P=0.17)。拮抗剂组的平均出生体重为 3264±662 g,激动剂组为 3341±562 g(P=0.37)。LBW 分别为 12.4%和 7%(P=0.19),VLBW 分别为 2.9%和 1%(P=0.34)。FET 周期中,围产期结局相似。新鲜和 FET 后,单胎活产儿的生长受限和大于胎龄儿率在两种方案中相似。

结论

在接受 GnRH 拮抗剂与 GnRH 激动剂方案治疗 IVF 后,围产期结局相似。在卵巢刺激中选择 GnRH 类似物应仅基于优化妊娠机会,而不是围产期结局的风险。

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