The First Affiliated Hospital of Zhengzhou University, Reproductive Medicine, Zhengzhou, China.
Sir Run Run Shaw Hospital of Zhejiang University, Reproductive Medicine, Hangzhou, China.
Aging (Albany NY). 2020 Mar 25;12(6):4918-4930. doi: 10.18632/aging.102919.
To compare the ovarian responses after administration of two recombinant follicle-stimulating hormone (r-FSH) preparations under gonadotropin-releasing hormone (GnRH) analogue downregulation, we conducted a phase 3, randomized, multicenter, assessor-blind, active-controlled, parallel group study. The primary outcome was the number of oocytes retrieved. The secondary outcomes included total dose and duration of r-FSH administered, oocyte quality, blood estradiol levels, follicular development, fertilization rates, implantation rates, and pregnancy rates (biochemical, clinical, and ongoing). A total of 451 patients with infertility were randomized to receive either Follitrope™ Prefilled Syringe or Gonal-F Pen for ovarian stimulation. The mean number of oocytes retrieved was 14.9 in the Follitrope Prefilled Syringe group, and 12.8 in the Gonal-F Pen group. The 95% confidence interval in the oocyte number difference between the groups was [-0.1, 4.2], demonstrating that Follitrope Prefilled Syringe was not inferior to Gonal-F Pen. The clinical pregnancy rates (Follitrope Prefilled Syringe vs. Gonal-F Pen: 55.4% vs. 51.9%) and ongoing pregnancy rates (44.1% vs. 43.0%) were similar between the groups. No clinically significant adverse events were observed in either group. In summary, our study indicates that Follitrope Prefilled Syringe is safe and efficacious for ovarian stimulation.
为了比较在 GnRH 类似物下调后两种重组卵泡刺激素（r-FSH）制剂给药后的卵巢反应，我们进行了一项 3 期、随机、多中心、评估者盲、活性对照、平行组研究。主要结局指标是取回的卵母细胞数量。次要结局指标包括 r-FSH 的总剂量和使用时间、卵母细胞质量、血液雌二醇水平、卵泡发育、受精率、着床率和妊娠率（生化、临床和持续）。共有 451 名不孕患者被随机分配接受 Follitrope™预充注射器或 Gonal-F Pen 进行卵巢刺激。Follitrope 预充注射器组的平均取卵数为 14.9 个，Gonal-F Pen 组为 12.8 个。两组之间的卵母细胞数量差异的 95%置信区间为[-0.1, 4.2]，表明 Follitrope 预充注射器并不劣于 Gonal-F Pen。临床妊娠率（Follitrope 预充注射器与 Gonal-F Pen：55.4% vs. 51.9%）和持续妊娠率（44.1% vs. 43.0%）在两组之间相似。两组均未观察到临床意义上的不良事件。总之，我们的研究表明，Follitrope 预充注射器用于卵巢刺激是安全有效的。
