GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study

GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study
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DOI:
10.1093/humrep/deaa107
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发表时间:
2020-07-01
期刊:
影响因子:
6.1
通讯作者:
Casper, R. F.
Casper, R. F.
中科院分区:
医学1区
文献类型:
--
作者:
Haas, J.;Bassil, R.;Casper, R. F.

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研究问题:与单独使用hCG相比,IVF周期中联合使用GnRH激动剂和人绒毛膜促性腺激素(hCG;双触发剂)是否能改善成熟卵母细胞数量和妊娠结局?简要答复:与单独使用hCG相比,使用双触发器进行最终卵泡成熟可以增加卵母细胞数量、成熟卵母细胞数量和囊胚数量(总数量和最高质量)。已知:hCG在控制性超促排卵结束时用作替代LH峰,以诱导最终卵母细胞成熟。最近,基于回顾性研究,GnRH激动剂和hCG的联合给药用于最终卵母细胞成熟研究设计、规模、持续时间:2016年5月至2018年6月间的单中心、随机对照、双盲临床试验,按意向治疗(ITT)进行分析。参与者/材料、设置、方法:155例正常反应患者随机接受hCG或双触发剂进行最终卵母细胞成熟。对患者年龄、BMI、AMH、获卵数、中期2(MII)卵母细胞数、受精卵和囊胚数、临床妊娠率和活产率等数据进行评估,并在双触发组和hCG组之间进行比较。我们在招募50%的患者后进行了计划的中期分析。基于在中期分析的总体结果,我们决定停止进一步的recruitment.Main结果和机会的作用:一百五十五例患者被纳入本研究。两组的年龄(36岁vs 35.3岁,P = NS)、BMI(24 kg/m2 vs 23.7 kg/m2)和AMH(20.1 pmol/l vs 22.4 pmol/l)相当。根据ITT分析,取卵数量(11.1对13.4,P = 0.002),MII卵母细胞(8.6 vs 10.3,P = 0.009),囊胚总数与hCG组相比,双触发组的囊胚移植率(2.9对3.9,P = 0.01)和优质囊胚移植率(44.7%对64.9%; P = 0.003)显著更高。临床妊娠率(24.3%对46.1%,OR 2.65(1.43-1.93),P = 0.009)和每次转移的活产率(22%对36.2%,OR = 1.98(1.05-3.75),P = 0.03)在双触发组中显著高于hCG组。研究结果的更广泛意义:如果双触发器的应用更广泛,观察到的增强反应可能会导致更好的IVF结局。
STUDY QUESTION: Does co-administration of GnRH agonist and Human chorionic gonadotropin (hCG; dual trigger) in IVF cycles improve the number of mature oocytes and pregnancy outcome compared to hCG alone?SUMMARY ANSWER: Using the dual trigger for final follicular maturation increases the number of oocytes, mature oocytes and number of blastocysts (total and top-quality) compared to triggering with hCG alone.WHAT IS KNOWN ALREADY: hCG is used at the end of controlled ovarian hyperstimulation as a surrogate LH surge to induce final oocyte maturation. Recently, based on retrospective studies, the co-administration of GnRH agonist and hCG for final oocyte maturation (dual trigger) has been suggested to improve IVF outcome and pregnancy ratesSTUDY DESIGN, SIZE, DURATION: A single center, randomized controlled, double-blinded clinical trial between May 2016 and June 2018 analyzed by intention to treat (ITT).PARTICIPANTS/MATERIALS, SETTINGS, METHODS: One hundred and fifty-five normal responder patients were randomized either to receive hCG or dual trigger for final oocyte maturation. Data on patients age, BMI, AMH, number of oocytes retrieved, number of metaphase 2 (MII) oocytes, zygotes and blastocysts, clinical pregnancy rate and live birth rate were assessed and compared between the dual trigger group and the hCG group. We performed a planned interim analysis after the recruitment of 50% of the patients. Based on the totality of outcomes at the interim analysis we decided to discontinue further recruitment.MAIN RESULTS AND THE ROLE OF CHANCE: One hundred and fifty-five patients were included in the study. The age (36 years versus 35.3 years P = NS), BMI (24 kg/m(2) versus 23.7 kg/m(2)) and the AMH (20.1 pmol/l versus 22.4 pmol/l) were comparable between the two groups. Based on ITT analysis, the number of eggs retrieved (11.1 versus 13.4, P = 0.002), the MII oocytes (8.6 versus 10.3, P = 0.009), total number of blastocysts (2.9 versus 3.9, P = 0.01) and top-quality blastocysts transferred (44.7% versus 64.9%; P = 0.003) were significantly higher in the dual trigger group compared to the hCG group. The clinical pregnancy rate (24.3% versus 46.1%, OR 2.65 (1.43-1.93), P = 0.009) and the live birth rate per transfer (22% versus 36.2%, OR = 1.98 (1.05-3.75), P = 0.03) were significantly higher in the dual trigger group compared to the hCG group.LIMITATIONS, REASONS FOR CAUTION: None.WIDER IMPLICATIONS OF THE FINDINGS: The enhanced response observed with the dual trigger might lead to better IVF outcomes were it used more widely.