University of Luebeck, Luebeck, Germany.
Glycotope GmbH, Berlin, Germany.
Reprod Biomed Online. 2020 Feb;40(2):331-341. doi: 10.1016/j.rbmo.2019.09.003. Epub 2019 Sep 16.
The study aimed to determine the standard treatment dose of follitropin epsilon for ovarian stimulation in the context of IVF treatment.
A total of 247 women aged 18-37 years were treated with either 52.5, 75, 112.5 or 150 IU follitropin epsilon daily, or 150 IU every other day, or 150 IU follitropin alfa daily in a long gonadotrophin-releasing hormone agonist protocol. The study was performed as a randomized, assessor-blinded, comparator-controlled, six-armed phase II trial in eight fertility clinics in two European countries.
The primary results were as follow. First, none of the doses of follitropin epsilon showed superiority for the main outcome measure, i.e. number of follicles ≥12 mm in size. Follitropin epsilon 75 IU produced results most similar to those of follitropin alfa 150 IU. In terms of secondary results, stronger effects of follitropin epsilon 112.5 IU compared with follitropin alfa 150 IU were seen for secondary outcome measures such as hormone concentrations (oestradiol, inhibin B and progesterone) and oocyte number.
Follitropin epsilon 75 IU daily results in a similar ovarian response to a standard dose of 150 IU follitropin alfa. This dose could be tested in a phase III trial.
本研究旨在确定卵泡刺激素 ε 在体外受精治疗中卵巢刺激的标准治疗剂量。
共有 247 名年龄在 18-37 岁的妇女接受了 52.5、75、112.5 或 150 IU 卵泡刺激素 ε 每日治疗，或 150 IU 隔日治疗，或 150 IU 卵泡刺激素α 每日治疗，均采用长效促性腺激素释放激素激动剂方案。该研究在两个欧洲国家的 8 家生育诊所进行了一项随机、评估者盲法、对照对照、六臂 II 期试验。
主要结果如下。首先，卵泡刺激素 ε 的任何剂量均未显示出对主要结局指标（即大小≥12mm 的卵泡数量）的优越性。卵泡刺激素ε75 IU 的结果与卵泡刺激素α 150 IU 最为相似。在次要结果方面，卵泡刺激素ε 112.5 IU 比卵泡刺激素α 150 IU 的作用更强，表现在激素浓度（雌二醇、抑制素 B 和孕酮）和卵母细胞数量等次要结局指标上。
卵泡刺激素 ε 75 IU 每日治疗可产生与 150 IU 卵泡刺激素α 标准剂量相似的卵巢反应。该剂量可在 III 期试验中进行测试。
