促性腺激素释放激素激动剂维持拮抗剂 IVF 周期黄体期：一项随机前瞻性试验。
GnRH agonists to sustain the luteal phase in antagonist IVF cycles: a randomized prospective trial.
机构信息
ASST Papa Giovanni XXIII, Piazza OMS 1, 24127, Bergamo, Italy.
Università degli Studi Bicocca, Milan, Italy.
出版信息
Reprod Biol Endocrinol. 2019 Nov 29;17(1):103. doi: 10.1186/s12958-019-0543-2.
BACKGROUND
The addition of a GnRH analogue to the luteal phase in in vitro fertilization programs has been seldom proposed due to the presence of GnRH receptors in the endometrium. The aim of the study was to evaluate the effect of triptorelin addition in short antagonist cycles, compared to cycles where the only supplementation was progesterone.
METHODS
The primary objective of this study was the study of the effect of Triptorelin addiction during the luteal phase on the live birth rate. Secondary objectives of efficacy were pregnancy rates and implantation rates, as well as safety in terms of OHSS risks. The study was a prospective, randomized, open study, performed in two independent Centers from July 2013 to October 2015. Patients were divided into three groups: a) Regular antagonist protocol, with only luteal progesterone; b) Antagonist protocol with luteal triptorelin as multiple injections, c) Antagonist protocol with luteal triptorelin as single bolus. Descriptive statistics were obtained for all the parameters. Mean and standard deviation were used for all quantitative parameters. Differences between percentages were studied using Chi-square test generalized to the comparison of several proportions.
RESULTS
A total number of 1344 patients completed the study, 786 under the age of 35 years, and 558 over 35 years. It was observed an increase of positive HCG results, Clinical pregnancy rates and Delivery rates when triptorelin was added in the luteal phase, irrespective whether as a single bolus or five injections. This increase was statistically significant both for pregnancy rates and delivery rates. The statistic difference between pregnancies and deliveries obtained with or without luteal triptorelin reached p < 0,01. No increase of OHSS risk was observed.
CONCLUSIONS
From this large study it appears that the concept of luteal phase supplementation should be revisited. From our study it appears that triptorelin addition to the luteal phase of antagonist cycles, either as a single bolus or using multiple injections, is a good tool to optimize ART results.
TRIAL REGISTRATION
The study was approved by the Ethics Committee of Provincia di Bergamo (n 1203/2013).
背景
由于 GnRH 受体存在于子宫内膜中，因此很少有在体外受精方案的黄体期添加 GnRH 类似物的提议。本研究的目的是评估在短拮抗剂周期中添加曲普瑞林的效果，与仅补充孕激素的周期相比。
方法
本研究的主要目的是研究黄体期添加曲普瑞林对活产率的影响。疗效的次要目标是妊娠率和着床率，以及在 OHSS 风险方面的安全性。该研究是一项前瞻性、随机、开放研究，于 2013 年 7 月至 2015 年 10 月在两个独立的中心进行。患者分为三组：a）常规拮抗剂方案，仅黄体期补充孕激素；b）黄体期多次注射曲普瑞林的拮抗剂方案；c）黄体期单次注射曲普瑞林的拮抗剂方案。所有参数均进行描述性统计。所有定量参数均采用平均值和标准差表示。使用卡方检验（广义用于比较多个比例）研究百分比之间的差异。
结果
共有 1344 名患者完成了这项研究，其中 786 名年龄在 35 岁以下，558 名年龄在 35 岁以上。观察到在黄体期添加曲普瑞林后，无论是单次注射还是五次注射，均可增加阳性 HCG 结果、临床妊娠率和分娩率。这一增加在妊娠率和分娩率方面均具有统计学意义。使用或不使用黄体期曲普瑞林获得的妊娠率和分娩率之间的统计学差异达到 p<0.01。未观察到 OHSS 风险增加。
结论
从这项大型研究中可以看出，黄体期补充的概念应该重新审视。从我们的研究中可以看出，在拮抗剂周期的黄体期添加曲普瑞林，无论是单次注射还是多次注射，都是优化 ART 结果的有效工具。
试验注册
该研究得到了 Bergamo 省伦理委员会的批准（n 1203/2013）。
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