Gynecology and Obstetrics 1, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, S. Anna Hospital, University of Torino, Via Ventimiglia 3, 10126, Turin, Italy.
Clinical Statistics, Department of Surgical Sciences, University of Torino, Corso Bramante 88, Turin, Italy.
J Assist Reprod Genet. 2020 May;37(5):1163-1170. doi: 10.1007/s10815-020-01742-5. Epub 2020 Mar 18.
To assess whether corifollitropin-α (CFα) late-start administration (day 4) and standard administration (day 2) can obtain similar oocyte yield and live birth rate.
A randomized controlled trial.
University Hospital IVF Unit.
One hundred thirteen women undergoing IVF.
Patients distributed in three subgroups (expected poor, normal, or high responders to FSH) were randomized into two treatment arms: (a) CFα late-start: CFα on day 4 + GnRH antagonist from day 8 + (when needed) recFSH from day 11; (b) CFα standard start: CFα on day 2 + GnRH antagonist from day 6 + (when needed) recFSH from day 9. IVF or ICSI was performed as indicated.
Considering the whole study group, the late-start regimen obtained comparable oocyte yield (8.9 ± 5.6 vs. 8.8 ± 6.2; p = n.s.), cPR/started cycle (25% vs. 31.6%, p = n.s.), and cumulative live birth rate (LBR)/ovum pickup (OPU) (29.2% vs. 37.7%, p = n.s.) than the standard regimen. The outcome of the two regimens was comparable in the two subgroups of high and normal responders. Differently, in poor responders, oocyte yield was similar, but LBR/OPU was significantly lower with late-start CFα administration that caused 40% cancellation rate due to monofollicular response. ROC curves showed that the threshold AMH levels associated with cycle cancellation were 0.6 ng/ml for late-start regimen and 0.2 ng/ml for standard regimen.
CFα may be administered on either day 2 or day 4 to patients with expected high or normal response to FSH without compromising oocyte yield and/or live birth rate. Differently, late-start administration is not advisable for expected poor responders with AMH ≤ 0.6 ng/ml.
NCT03816670.
评估促卵泡素-α（CFα）起始延迟（第 4 天）与标准起始（第 2 天）给药能否获得相似的卵母细胞产量和活产率。
随机对照试验。
大学医院 IVF 单位。
113 名接受 IVF 的女性。
患者分为三组（预期低、中、高 FSH 反应者），随机分为两组治疗组：（a）CFα 起始延迟：第 4 天给予 CFα+第 8 天给予 GnRH 拮抗剂+第 11 天（必要时）给予 recFSH；（b）CFα 标准起始：第 2 天给予 CFα+第 6 天给予 GnRH 拮抗剂+第 9 天（必要时）给予 recFSH。根据需要进行 IVF 或 ICSI。
考虑整个研究组，延迟起始方案获得了相似的卵母细胞产量（8.9±5.6 对 8.8±6.2；p=无显著性差异）、临床妊娠率/起始周期（25%对 31.6%；p=无显著性差异）和累积活产率/取卵（29.2%对 37.7%；p=无显著性差异），与标准方案相当。在高反应和正常反应的两个亚组中，两种方案的结果相当。不同的是，在低反应者中，卵母细胞产量相似，但使用延迟起始 CFα 治疗时，活产率显著降低，导致 40%的周期取消，原因是单卵泡反应。ROC 曲线显示，与周期取消相关的 AMH 水平的临界值为延迟起始方案的 0.6ng/ml 和标准方案的 0.2ng/ml。
对于预期高或中 FSH 反应的患者，CFα 可在第 2 天或第 4 天给予，而不会影响卵母细胞产量和/或活产率。不同的是，对于 AMH≤0.6ng/ml 的预期低反应者，不建议使用延迟起始给药。
NCT03816670。
