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目的前瞻性随机比较黄体期GnRHa降调节方案中基因重组HCG(r-HCG)与尿源性HCG(u-HCG)在我国妇女中诱导卵子成熟的IVF/ICSI结局及安全性。方法收集接受IVF/ICSI助孕的不孕患者568例,随机分成2组:A组用r-HCG皮下注射诱导排卵,B组用u-HCG肌肉注射诱导排卵,比较两组间诱导卵子成熟效应和临床结局。结果 (1)两组间除2PN率A组明显高于B组外,其余超排卵参数、获卵数、MⅡ卵数、受精率、临床妊娠率等均无统计学差异;(2)两组的早发OHSS率无统计学差异,而晚发OHSS率B组明显高于A组,两组均无患者发生注射后过敏反应等情况;(3)随着血清β-HCG浓度增高BMI逐渐减小,获卵数、MⅡ卵数、MⅡ卵率、受精率、可移植胚胎数均有增加趋势,但着床率和妊娠率并未受到影响;(4)A组中有1例注射r-HCG后血清β-HCG<1.2mU/ml,补注射u-HCG后34-36h取卵获得临床妊娠。结论 r-HCG与u-HCG在黄体期GnRHa降调节方案中能获得基本相同的诱导卵子成熟效应和临床结局;对BMI高的患者可考虑适当加大HCG量以保证足够的HCG浓度;建议HCG注射后12-14h检测血清β-HCG浓度,一旦发现浓度过低,应该更换药物或选择不同批次进行补注射后取卵,尽可能挽救该周期,保证患者利益。
Objective To prospectively and randomly compare the IVF / ICSI outcomes and safety of recombinant human HCG (r-HCG) and uro-HCG (u-HCG) inducing ovulation maturation in Chinese women in the regimen of luteal phase GnRHa. Methods 568 infertile women receiving IVF / ICSI assisted pregnancy were randomly divided into 2 groups: group A received ovarian stimulation with r-HCG subcutaneously; group B received u-HCG intramuscular injection to induce ovulation; induced egg maturation effect between the two groups And clinical outcome. Results (1) There was no significant difference between the two groups except that the 2PN rate in group A was significantly higher than that in group B, and the other parameters of superovulation, number of oocytes retrieved, number of MII oocytes, fertilization rate and clinical pregnancy rate were no significant difference. (2) The incidence of OHSS was not statistically different from that of late OHSS, while the incidence of late-onset OHSS in group B was significantly higher than that in group A, and no allergic reaction occurred after injection in both groups. (3) With the increase of serum β-HCG concentration, The number of oocytes retrieved, the number of MⅡ oocytes, the number of MⅡ oocytes, the fertilization rate and the number of transferable embryos all increased, but the implantation rate and pregnancy rate were not affected. (4) In group A, 1 r- After HCG serum β-HCG <1.2mU / ml, injection of u-HCG 34-36h after ovulation to obtain clinical pregnancy. Conclusions Both r-HCG and u-HCG can achieve the same induction effect and clinical outcome in the luteal phase GnRHa downregulation program. For patients with high BMI, HCG concentration may be appropriately increased to ensure adequate HCG concentration. HCG Serum concentrations of β-HCG were measured at 12-14 h after injection. Once the concentration was found to be too low, drugs should be replaced or different batches were selected for injection and ovulation, and the cycle should be rescued as far as possible to ensure patient’s benefit.