A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol.
A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol.
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DOI：
10.1093/humrep/dep291
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发表时间：
2009-12
期刊：
影响因子：
--
通讯作者：
ENGAGE Investigators
中科院分区：
文献类型：
--
作者：
Devroey P;Boostanfar R;Koper NP;Mannaerts BM;Ijzerman-Boon PC;Fauser BC;ENGAGE Investigators
Corifollitropin α是一种缺乏LH活性的融合蛋白，与重组FSH （rFSH）相比，其消除半衰期更长，达到峰值水平的时间更长。在卵巢刺激的第一周内，单次注射促性腺激素可代替每天7次的促性腺激素注射。在这项大型、双盲、随机、非劣效性试验中，在刺激的第一周注射一次150µg corifollitropin α后，评估持续妊娠率，并与使用标准GnRH拮抗剂方案每天注射200 IU rFSH进行比较。研究人群包括1506名接受治疗的患者，平均年龄31.5岁，体重68.6 kg。corifollitoppin α - fa组的持续妊娠率为38.9%，rFSH组为38.1%，估计无显著差异为0.9%[95%置信区间（CI）：−3.9；5.7]支持corifollitoppin。妊娠率的分层分析证实了这一主要结局的稳健性，无论IVF或ICSI，或移植的胚胎数量，结果都是相似的。与rFSH相比，corifollitropin α fa的卵泡反应略高，导致卵丘-卵母细胞复合物数量增加[估计差值1.2 (95% CI: 0.5; 1.9)]，而刺激的中位持续时间相同（9天），（中度/重度）卵巢过度刺激综合征的发生率相同（4.1和2.7%，分别P = 0.15）。对于接受GnRH拮抗剂联合卵巢刺激的潜在正常反应患者来说，corifollitoppin是一种新颖有效的治疗选择，可导致高持续妊娠率，与每日使用rFSH达到的妊娠率相等。该试验注册编号为ClinicalTrials.gov，注册编号为NTC00696800。
Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation. In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 µg corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol. The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9% for the corifollitropin alfa group and 38.1% for rFSH were achieved, with an estimated non-significant difference of 0.9% [95% confidence interval (CI): −3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulus–oocyte-complexes compared with rFSH [estimated difference 1.2 (95% CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7%, respectively P = 0.15). Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.
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影响因子：
4.8
作者：
LAPOLT, PS;NISHIMORI, K;HSUEH, AJW
通讯作者：
HSUEH, AJW
影响因子：
6.1
作者：
Heijnen, EMEW;Macklon, NS;Fauser, BCJM
通讯作者：
Fauser, BCJM
影响因子：
6.1
作者：
Cédrin-Durnerin, I;Grange-Dujardin, D;Hugues, JN
通讯作者：
Hugues, JN
影响因子：
6.7
作者：
Olivius, C;Friden, B;Bergh, C
通讯作者：
Bergh, C
影响因子：
6.1
作者：
Bouloux, PMG;Handelsman, DJ;Itskovitz-Eldor, J
通讯作者：
Itskovitz-Eldor, J