Merck Serono, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK.
Reprod Biol Endocrinol. 2010 Nov 8;8:137. doi: 10.1186/1477-7827-8-137.
Previous studies have reported conflicting results for the comparative doses of recombinant follicle stimulating hormone (rFSH) and highly purified human menopausal gonadotrophin (hMG-HP) required per cycle of in vitro fertilisation (IVF); the aim of this study was to determine the average total usage of rFSH versus hMG-HP in a 'real-world' setting using routine clinical practice.
This retrospective chart review of databases from four European countries investigated gonadotrophin usage, oocyte and embryo yield, and pregnancy outcomes in IVF cycles (± intra-cytoplasmic sperm injection) using rFSH or hMG-HP alone. Included patients met the National Institute for Health and Clinical Excellence (NICE) guideline criteria for IVF and received either rFSH or hMG-HP. Statistical tests were conducted at 5% significance using Chi-square or t-tests.
Of 30,630 IVF cycles included in this review, 74% used rFSH and 26% used hMG-HP. A significantly lower drug usage per cycle for rFSH than hMG-HP (2072.53 +/- 76.73 IU vs. 2540.14 +/- 883.08 IU, 22.6% higher for hMG-HP; p < 0.01) was demonstrated. The median starting dose was also significantly lower for rFSH than for hMG-HP (150 IU vs. 225 IU, 50% higher for hMG-HP, p < 0.01). The average oocyte yield per IVF cycle in patients treated with rFSH was significantly greater than with hMG-HP (10.80 +/- 6.02 vs. 9.77 +/- 5.53; p < 0.01), as was the average mature oocyte yield (8.58 +/- 5.27 vs. 7.72 +/- 4.59; p < 0.01). No significant differences were observed in pregnancy outcomes including spontaneous abortion between the two treatments. There was a significantly higher rate of OHSS (all grades) with rFSH (18.92% vs. 14.09%; p < 0.0001). The hospitalisation rate due to OHSS was low but significantly higher in the rFSH group (1.07% of cycles started vs. 0.67% of cycles started with rFSH and hMG-HP, respectively; p = 0.002).
Based on these results, IVF treatment cycles with rFSH yield statistically more oocytes (and more mature oocytes), using significantly less IU per cycle, versus hMG-HP. The incidence of all OHSS and hospitalisations due to OHSS was significantly higher in the rFSH cycles compared to the hMG-HP cycles. However, the absolute incidence of hospitalisations due to OHSS was similar to that reported previously. These results suggest that the perceived required dosage with rFSH is currently over-estimated, and the higher unit cost of rFSH may be offset by a lower required dosage compared with hMG-HP.
之前的研究对于体外受精（IVF）周期中所需的重组卵泡刺激素（rFSH）和高纯度人绝经期促性腺激素（hMG-HP）的比较剂量得出了相互矛盾的结果；本研究旨在使用常规临床实践确定 rFSH 与 hMG-HP 的平均总用量。
这项来自四个欧洲国家的数据库回顾性图表研究调查了使用 rFSH 或 hMG-HP 单独进行的 IVF 周期（±胞浆内精子注射）中的促性腺激素使用、卵母细胞和胚胎产量以及妊娠结局。符合国家卫生与临床优化研究所（NICE）IVF 指南标准的纳入患者接受了 rFSH 或 hMG-HP 治疗。使用卡方检验或 t 检验在 5%的显著性水平上进行了统计检验。
在本综述中，30630 个 IVF 周期中，74%使用 rFSH，26%使用 hMG-HP。与 hMG-HP 相比，rFSH 的每周期药物用量明显较低（2072.53 +/- 76.73 IU 与 2540.14 +/- 883.08 IU，hMG-HP 高 22.6%；p < 0.01）。rFSH 的起始剂量中位数也明显低于 hMG-HP（150 IU 与 225 IU，hMG-HP 高 50%，p < 0.01）。rFSH 治疗的患者每个 IVF 周期的平均卵母细胞产量明显大于 hMG-HP（10.80 +/- 6.02 与 9.77 +/- 5.53；p < 0.01），平均成熟卵母细胞产量也是如此（8.58 +/- 5.27 与 7.72 +/- 4.59；p < 0.01）。两种治疗方法之间的妊娠结局（包括自然流产）没有观察到显著差异。rFSH 组（18.92%）的卵巢过度刺激综合征（OHSS）（所有等级）发生率明显高于 hMG-HP 组（14.09%；p < 0.0001）。OHSS 的住院率较低，但 rFSH 组明显较高（开始的周期中分别为 1.07%和 0.67%；p = 0.002）。
根据这些结果，与 hMG-HP 相比，rFSH 治疗的 IVF 周期每周期使用的 IU 明显较少，但统计上产生的卵母细胞（和更多成熟卵母细胞）更多。rFSH 周期中所有 OHSS 和因 OHSS 导致的住院的发生率明显高于 hMG-HP 周期。然而，因 OHSS 导致的住院的绝对发生率与之前报道的相似。这些结果表明，目前 rFSH 的预期所需剂量被高估了，与 hMG-HP 相比，rFSH 的单位成本较高可能被较低的所需剂量所抵消。
