Research question

The objective of this investigation was to determine the daily follitropin delta dose (µg) providing a similar ovarian response to 150 IU/day follitropin alfa.

Design

The study was a post-hoc analysis of ovarian response in 1591 IVF/intracytoplasmic sperm injection (ICSI) patients undergoing ovarian stimulation in a gonadotrophin-releasing hormone antagonist protocol in two recent randomized, assessor-blind, controlled trials in the development programme for follitropin delta: a phase II dose–response trial with a reference arm of a fixed daily dose of 150 IU follitropin alfa throughout stimulation, and a phase III efficacy trial with a comparator arm of 150 IU/day follitropin alfa as a starting dose.

Results

Daily follitropin delta doses of 10.0 µg (95% confidence interval [CI] 7.9–12.8) and 10.3 µg (95% CI 9.7–10.8) yielded the same number of oocytes as 150 IU/day follitropin alfa for all patients participating in the phase II and III trials, respectively. When analysing patients with either normal or high ovarian reserve (based on serum anti-Mullerian hormone ≥15 pmol/l) and no dose changes, the same number of oocytes was obtained with 150 IU/day follitropin alfa and daily doses of follitropin delta of 9.7 µg (95% CI 7.5–12.4) and 9.3 µg (95% CI 8.6–10.1) in the two trials. Daily follitropin delta doses in the range 9.5–10.4 µg were consistently estimated to correspond to 150 IU/day follitropin alfa for serum oestradiol concentration and number of follicles ≥12 mm at the end of stimulation across analysis populations in the phase III trial.

Conclusions

A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.

中文翻译：

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确定可提供与 150 IU/天促卵泡素 α 相当的卵巢反应的促卵泡素 delta 剂量。

研究问题

本次调查的目的是确定每日促卵泡素 delta 剂量 (μg) 提供与 150 IU/天促卵泡素 alfa 相似的卵巢反应。

设计

该研究是对 1591 名接受促性腺激素释放激素拮抗剂方案中的卵巢刺激的 IVF/卵胞浆内单精子注射 (ICSI) 患者的卵巢反应的事后分析，这些患者在卵泡激素开发计划的两项随机、评估者盲法、对照试验中进行delta：一项 II 期剂量反应试验，参考组在整个刺激期间的固定日剂量为 150 IU 促卵泡激素 α，以及一项 III 期疗效试验，对照组为 150 IU/天的促卵泡激素 α 作为起始剂量。

结果

10.0 µg（95% 置信区间 [CI] 7.9-12.8）和 10.3 µg（95% CI 9.7-10.8）的每日促卵泡素 delta 剂量为所有参与该阶段的患者产生与 150 IU/天促卵泡素 α 相同数量的卵母细胞II 和 III 试验，分别。当分析卵巢储备正常或高（基于血清抗苗勒管激素≥15 pmol/l）且没有剂量变化的患者时，使用 150 IU/天的促卵泡激素 α 和每日剂量的促卵泡激素 delta 获得相同数量的卵母细胞两项试验中分别为 9.7 µg (95% CI 7.5–12.4) 和 9.3 µg (95% CI 8.6–10.1)。在 III 期试验的分析人群中，在刺激结束时，9.5-10.4 µg 范围内的每日促卵泡素 delta 剂量一致估计对应于 150 IU/天的促卵泡素α，用于血清雌二醇浓度和≥12 mm 的卵泡数量。

结论

在 IVF/ICSI 患者中，每日 10 µg 的促卵泡激素 delta 剂量提供与 150 IU/天的促卵泡激素 alfa 相似的卵巢反应。