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目的评价质量标称重组人促卵泡激素α(filled-by-mass recombinant human follitropinα,FbM-rhFSHα)预装注射笔在中国人群辅助生殖技术的常规控制性卵巢刺激中应用的有效性和安全性。方法此试验是前瞻性、多中心、观察性研究。从2008年12月至2010年1月在11家生殖中心中共1549名患者应用FbM-rhFSHα注射笔进行控制性卵巢刺激,并对取卵数、胚胎数、妊娠率以及妊娠率与基线数据的关系进行分析,同时评价多胎妊娠、卵巢过度刺激综合征(OHSS)发生等方面的安全性。结果 1548名患者完成研究,1526名患者取得卵子,平均取卵数是12.95±6.38;1508名患者获得胚胎,平均获得胚胎数是8.39±4.92;临床妊娠率是41.2%(638/1548)。在妊娠相关因素的分析中,年龄>40岁分别与年龄≤35岁和35<年龄≤40岁的患者比较,临床妊娠率明显降低(18.2%,42.1%,39.1%;P=0.0146)。BMI≥27的患者与BMI<18.5,18.5≤BMI<24,24≤BMI<27的患者比较临床妊娠率明显降低(26.4%,42.6%,42.3%,40.7%;P=0.0322)。单因素不孕患者的临床妊娠率高于多因素不孕的患者(44.7%vs37.7%,P=0.0062)。首次接受促排卵治疗的患者的临床妊娠率显著高于既往有促排卵治疗史患者(42.8%vs32.9%,P=0.0047)。在获得妊娠患者中多胎妊娠率为1.25%(8/638)。OHSS发生率0.45%(7/1549),重度OHSS发生率0.06%(1/1549)。结论应用FbM-rhFSHα注射笔进行控制性卵巢刺激具有良好的有效性和安全性。
Objective To evaluate the effectiveness and safety of filled-by-mass recombinant human follitropin α (FbM-rhFSHα) prefilled with pen in the routine controlled ovarian stimulation of Chinese assisted reproductive technology. Methods This trial is a prospective, multicenter, observational study. From December 2008 to January 2010, a total of 1549 patients in 11 centers of gynecology were enrolled in this study. Controlled ovarian stimulation with FbM-rhFSHα injection pen was performed. The relationship between number of fetuses, number of embryos, pregnancy rate and pregnancy rate and baseline data Analysis, at the same time evaluation of multiple pregnancy, ovarian hyperstimulation syndrome (OHSS) and other aspects of safety. RESULTS: A total of 1548 patients completed the study. 1526 patients achieved the egg with an average of 12.95 ± 6.38 eggs. In 1508 patients, the number of embryos obtained was 8.39 ± 4.92. The clinical pregnancy rate was 41.2% (638/1548). In the analysis of pregnancy-related factors, clinical pregnancy rates were significantly lower in patients> 40 years of age and 35 and <35 years respectively (18.2%, 42.1%, 39.1%; P = 0.0146). Clinical pregnancy rates were significantly lower in patients with BMI ≥ 27 compared with those with BMI <18.5, 18.5 ≤ BMI <24, 24 ≤ BMI <27 (26.4%, 42.6%, 42.3%, 40.7%; P = 0.0322). The clinical pregnancy rates of single-infertility patients were higher than those of multi-infertility patients (44.7% vs37.7%, P = 0.0062). The first pregnancy on ovulation was associated with significantly higher clinical pregnancy rates than those with prior ovulation induction therapy (42.8% vs 32.9%, P = 0.0047). The multiple pregnancy rate was 1.25% (8/638) in those who got the pregnancy. The incidence of OHSS was 0.45% (7/1549), and the incidence of severe OHSS was 0.06% (1/1549). Conclusion The FbM-rhFSHα injection pen has good efficacy and safety in controlling ovarian stimulation.