IVI-RMA Seville, Avda. República Argentina 58, Seville, ES-41011, Spain; Departamento de Cirugía, Universidad de Sevilla, Avda. Sánchez Pizjuan S/N, Seville, ES-41009, Spain; Departamento de Biología Molecular e Ingeniería Bioquímica, Universidad Pablo de Olavide, Seville ES-41013, Spain.
IVF CUBE SE, Prague 160 00, Czech Republic.
Reprod Biomed Online. 2019 Apr;38(4):528-537. doi: 10.1016/j.rbmo.2018.12.032. Epub 2018 Dec 23.
Is individualization of dosing with follitropin delta in sequential ovarian stimulation cycles an effective preventive strategy for ovarian hyperstimulation syndrome risk? If so, for which patients does an individualized strategy provide the greatest OHSS risk reduction and/or the need for additional preventive interventions?
A secondary analysis of three ovarian stimulation cycles in IVF/intracytoplasmic sperm injection patients included in one randomized, assessor-blinded trial comparing two recombinant FSH preparations (ESTHER-1, NCT01956110), and a second trial in women undergoing up to two additional cycles (ESTHER-2, NCT01956123). Of 1326 women (aged 18-40 years) randomized and treated with follitropin delta or alfa in cycle 1, 513 continued to cycle 2 and 188 to cycle 3. Follitropin delta and alfa doses were maintained/adjusted according to ovarian response in the previous cycle.
Individualized dosing with follitropin delta significantly reduced moderate/severe OHSS and/or preventive interventions (P=0.018) versus conventional dosing with follitropin alfa in patients undergoing up to three ovarian stimulation cycles. The greatest benefit was observed in patients in the highest anti-Müllerian hormone (AMH) quartile (P=0.012). On evaluating separately, individualized dosing with follitropin delta significantly lowered the incidences of moderate/severe OHSS (P=0.036) and preventive interventions (P=0.044) versus follitropin alfa.
An individualized follitropin delta dosing regimen decreased the risk of moderate/severe OHSS as well as the incidence of preventive interventions versus a conventional follitropin alfa regimen. An analysis per AMH quartile indicated that these statistically significant differences are driven mainly by patients with the highest pretreatment AMH levels.
在连续卵巢刺激周期中，使用卵泡刺激素 delta 进行个体化给药是否是预防卵巢过度刺激综合征（OHSS）风险的有效策略？如果是，对于哪些患者，个体化策略能最大程度降低 OHSS 风险和/或需要额外的预防干预？
这是一项对纳入一项比较两种重组促卵泡激素制剂（ESTHER-1，NCT01956110）的随机、评估者设盲试验的三个 IVF/胞浆内精子注射周期中的二次分析，以及一项在接受最多两个额外周期的女性中进行的第二项试验（ESTHER-2，NCT01956123）。在接受卵泡刺激素 delta 或 alfa 治疗的 1326 名年龄在 18-40 岁的女性中，有 513 名继续进入第 2 周期，188 名进入第 3 周期。在前一个周期中根据卵巢反应调整维持/调整卵泡刺激素 delta 和 alfa 的剂量。
与常规剂量的卵泡刺激素 alfa 相比，在接受多达三个卵巢刺激周期的患者中，个体化剂量的卵泡刺激素 delta 显著降低了中重度 OHSS 和/或预防干预的发生（P=0.018）。在抗苗勒管激素（AMH）最高四分位数的患者中观察到最大的获益（P=0.012）。分别评估时，与卵泡刺激素 alfa 相比，个体化剂量的卵泡刺激素 delta 显著降低了中重度 OHSS 的发生率（P=0.036）和预防干预的发生率（P=0.044）。
与常规卵泡刺激素 alfa 方案相比，个体化卵泡刺激素 delta 给药方案降低了中重度 OHSS 的风险和预防干预的发生率。根据 AMH 四分位数的分析表明，这些具有统计学意义的差异主要是由预处理 AMH 水平最高的患者驱动的。
