Corifollitropin alfa 用于反应不良患者的前瞻性随机研究。
Corifollitropin alfa for poor responders patients, a prospective randomized study.
机构信息
Division of Reproductive Endocrinology, ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.
出版信息
Reprod Biol Endocrinol. 2020 Jul 9;18(1):67. doi: 10.1186/s12958-020-00628-6.
BACKGROUND
Poor ovarian response remains one of the biggest challenges for reproductive endocrinologists. The introduction of corifollitropin alpha (CFA) offered an alternative option to other gonadotropins for its longer half-life, its more rapid achievement of the threshold and higher FSH levels. We compared two different protocols with CFA, a long agonist and a short antagonist, and a no-CFA protocol.
METHODS
Patients enrolled fulfilled at least two of the followings: AFC < 5, AMH < 1,1 ng/ml, less than three oocytes in a previous cycle, age > 40 years. Ovarian stimulation with an antagonist protocol was performed either with 300 UI rFSH and 150 UI rLH or 300UI HMG. In the long agonist group, after pituitary suppression with triptorelin, CFA was given the 1-2th day of cycle and 300 UI rFSH and 150 UI rLH the 5th day. In the short antagonist group CFA was given the 1-2th day of cycle and 300 UI rFSH and 150 UI rLH the 5th day. The primary objective was the effect on the number of oocytes and MII oocytes. Secondary objective were pregnancy rates, ongoing pregnancies and ongoing pregnancies per intention to treat.
RESULTS
The use of CFA resulted in a shorter lenght of stimulation and a lower number of suspended treatments. Both the CFA protocols were significantly different from the no-CFA group in the number of retrieved oocytes (p < 0,05), with a non-significant difference in favour of the long agonist protocol. Both CFA groups yielded higher pregnancy rates, especially the long protocol, due to the higher number of oocytes retrieved (p < 0,05), as implantation rates did not differ. The cumulative pregnancy rate was also different, due to the higher number of cryopreserved blastocysts (p < 0,02).
CONCLUSIONS
The long agonist protocol with the addition of rFSH and rLH showed the best results in all the parameters. A short antagonist protocol with CFA was less effective, but not significantly, although provided better results compared to the no-CFA group. We suggest that a long agonist protocol with CFA and recombinant gonadotropins might be a valuable option for poor responders.
TRIAL REGISTRATION
The study was approved by the local Ethics Committee (EudraCT2015-002817-31).
背景
卵巢反应不良仍然是生殖内分泌学家面临的最大挑战之一。由于其更长的半衰期、更快达到阈值和更高的 FSH 水平，促卵泡激素-α（CFA）的应用为其他促性腺激素提供了另一种选择。我们比较了两种不同的 CFA 方案，一种是长激动剂方案，一种是短拮抗剂方案，还有一种是无 CFA 方案。
方法
入组的患者至少满足以下两项标准：AFC<5、AMH<1.1ng/ml、前一周期取卵数<3、年龄>40 岁。采用拮抗剂方案进行卵巢刺激，使用 300UI rFSH 和 150UI rLH 或 300UI HMG。在长激动剂组中，使用曲普瑞林抑制垂体后，于周期第 1-2 天给予 CFA，第 5 天给予 300UI rFSH 和 150UI rLH。在短拮抗剂组中，于周期第 1-2 天给予 CFA，第 5 天给予 300UI rFSH 和 150UI rLH。主要目的是观察 CFA 对卵母细胞和 MII 卵母细胞数量的影响。次要目的是妊娠率、持续妊娠率和意向治疗持续妊娠率。
结果
使用 CFA 可缩短刺激时间并减少治疗暂停。与无 CFA 组相比，两种 CFA 方案的获卵数均有显著差异（p<0.05），但长激动剂方案无显著差异。由于获卵数增加（p<0.05），两种 CFA 组的妊娠率均较高，尤其是长方案，由于着床率无差异。由于冷冻胚胎数量增加（p<0.02），累积妊娠率也不同。
结论
添加 rFSH 和 rLH 的长激动剂方案在所有参数中表现最佳。含 CFA 的短拮抗剂方案效果较差，但与无 CFA 组相比差异无统计学意义。我们建议，对于卵巢反应不良的患者，CFA 联合重组促性腺激素的长激动剂方案可能是一种有价值的选择。
试验注册
该研究得到了当地伦理委员会的批准（EudraCT2015-002817-31）。
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