Vaiarelli Alberto, Pittana Erika, Cimadomo Danilo, Ruffa Alessandro, Colamaria Silvia, Argento Cindy, Giuliani Maddalena, Petrone Pasquale, Fabozzi Gemma, Innocenti Federica, Taggi Marilena, Ata Baris, Rienzi Laura, Ubaldi Filippo Maria
IVIRMA Global Research Alliance, GENERA, Clinica Valle Giulia, Rome, Italy.
Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.
J Assist Reprod Genet. 2025 Jan;42(1):255-264. doi: 10.1007/s10815-024-03317-0. Epub 2024 Nov 13.
This study is to evaluate the effectiveness of a PPOS protocol in poor prognosis patients undergoing IVF with DuoStim and PGT-A versus the conventional protocol with GnRH antagonist.
Retrospective cohort study encompassing 444 couples obtained matching one PPOS-DuoStim with two antagonist-DuoStim cycles at a private IVF center between 2020 and 2023 (average maternal age: 40 years, average cumulus-oocyte complexes collected after the first stimulation: 5). The study was powered to exclude a two-sided different euploid blastocyst rate per MII oocytes (EBR per MII) in the two groups (alpha = 0.05, power = 0.9, effect size = 0.3). All cycles involved ICSI, blastocyst stage PGT-A, and single vitrified-warmed euploid transfers. We compared all embryological and clinical outcomes within each group (first vs. second stimulations), and among the two study arms (first stimulation vs. first stimulation; second stimulations vs. second stimulation; overall). The overall EBR per MII was the primary study outcome. The cumulative-live-birth-rate per concluded cycles (CLBR) was the main secondary outcome.
In the second stimulations, we obtained a greater number of COCs and MIIs in both antagonist- and PPOS-DuoStim groups. No difference was observed for all embryological and clinical outcomes when comparing the two stimulations within each group. All embryological and clinical outcomes were comparable also between the two groups, including the EBR per MII. To date, 285 and 121 antagonist- and PPOS-DuoStim cycles were concluded. The CLBR was comparable between the groups: 26% vs. 29%.
PPOS-DuoStim holds potential for being an efficient, patient-friendly, and possibly cost-effective approach that does not compromise treatment efficacy. Future investigations must explore PPOS effect on follicular recruitment, neonatal, and long-term outcomes.
本研究旨在评估在接受双刺激方案(DuoStim)和植入前基因检测非整倍体(PGT-A)的体外受精(IVF)预后不良患者中,改良卵泡期促性腺激素释放激素拮抗剂方案(PPOS)与传统促性腺激素释放激素拮抗剂方案的有效性。
回顾性队列研究,纳入了444对夫妇,这些夫妇在2020年至2023年期间于一家私立IVF中心进行了匹配,其中一个PPOS-DuoStim周期与两个拮抗剂-DuoStim周期(平均产妇年龄:40岁,首次刺激后收集的平均卵丘-卵母细胞复合体数量:5个)。该研究旨在排除两组中每个成熟卵母细胞(MII)的整倍体囊胚率(EBR per MII)的双侧差异(α = 0.05,检验效能 = 0.9,效应大小 = 0.3)。所有周期均涉及卵胞浆内单精子注射(ICSI)、囊胚期PGT-A以及单个玻璃化-解冻整倍体移植。我们比较了每组内(首次刺激与第二次刺激)以及两个研究组之间(首次刺激与首次刺激;第二次刺激与第二次刺激;总体)的所有胚胎学和临床结局。每个MII的总体EBR是主要研究结局。每个完成周期的累积活产率(CLBR)是主要次要结局。
在第二次刺激中,拮抗剂组和PPOS-DuoStim组均获得了更多的卵丘-卵母细胞复合体(COC)和MII。在比较每组内的两次刺激时,所有胚胎学和临床结局均未观察到差异。两组之间的所有胚胎学和临床结局也具有可比性,包括每个MII的EBR。迄今为止,分别有285个和121个拮抗剂组和PPOS-DuoStim组的周期完成。两组之间的CLBR具有可比性:分别为26%和29%。
PPOS-DuoStim有潜力成为一种高效、对患者友好且可能具有成本效益的方法,同时不影响治疗效果。未来的研究必须探索PPOS对卵泡募集、新生儿和长期结局的影响。