Merck Serono SA, Geneva, Switzerland.
Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6.
The CONSORT dosing algorithm individualizes recombinant human FSH (r-hFSH) doses for assisted reproduction technologies, assigning 37.5 IU increments according to patient characteristics: basal FSH, body mass index, age and antral follicle count. A prospective, uncontrolled, international, 18-centre, pilot study of normo-ovulatory women aged 18-34 years inclusive undergoing a long agonist treatment protocol was performed. Follitropin alfa filled-by-mass (GONAL-f®) dose was assigned by the algorithm and was intended to be altered only for risk of ovarian hyperstimulation syndrome (OHSS). Primary end-point was number of oocytes retrieved. Dose groups containing ≥5 patients were analysed: 75 IU (n = 48), 112.5 IU in = 45), 150 IU (n = 34), 187.5 IU (n = 24), 225 IU (n = 10). Cancellations due to inadequate response were higher than expected in the 75 IU group (12/48). Overall, a median of 9.0 oocytes were retrieved (8.5, 8.0, 10.0, 12.0 and 8.0 in the 75, 112.5, 150, 187.5 and 225 IU groups respectively). Clinical pregnancy rates/cycle started were 31.3, 31.1, 35.3, 50.0 and 20.0%, respectively (overall, 34.2%). Two patients had severe OHSS. Use of the CONSORT algorithm achieved an adequate oocyte yield and good pregnancy rates in this preliminary study. Adjustment of the algorithm could reduce cancellation rates.
CONSORT 给药算法根据患者特征个体化重组人促卵泡激素（r-hFSH）剂量，分配 37.5IU 增量：基础 FSH、体重指数、年龄和窦卵泡计数。对年龄在 18-34 岁（含）的接受长激动剂治疗方案的正常排卵妇女进行了一项前瞻性、非对照、国际性、18 中心、试点研究。采用按质量填充的卵泡刺激素阿尔法（GONAL-f®），根据算法分配剂量，仅因卵巢过度刺激综合征（OHSS）风险而改变。主要终点是取回的卵母细胞数量。包含≥5 名患者的剂量组进行了分析：75IU（n=48）、112.5IU（n=45）、150IU（n=34）、187.5IU（n=24）、225IU（n=10）。由于反应不足而取消的患者在 75IU 组中高于预期（12/48）。总体而言，中位数取回 9.0 个卵母细胞（75、112.5、150、187.5 和 225IU 组分别为 8.5、8.0、10.0、12.0 和 8.0）。临床妊娠率/开始周期分别为 31.3%、31.1%、35.3%、50.0%和 20.0%（总体为 34.2%）。有 2 名患者发生严重 OHSS。在这项初步研究中，CONSORT 算法的使用实现了足够的卵母细胞产量和良好的妊娠率。调整算法可以降低取消率。
