Unit of Gynecology, Department of Surgical and Medical Sciences and Translational Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
J Ovarian Res. 2024 Mar 14;17(1):60. doi: 10.1186/s13048-024-01372-w.
Follitropin delta is a novel recombinant follicle stimulating hormone preparation uniquely expressed in a human fetal retinal cell line by recombinant DNA technology. To date, no systematic review was available about the safety and the efficacy of the follitropin delta. The objective of this study was systematically reviewing the available literature and to provide updated evidence regarding the efficacy-safety profile of follitropin delta when compared to other gonadotropin formulations for ovarian stimulation in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles.
An extensive search was performed to identify phase 1, phase 2 and phase 3 RCTs in humans focused on follitropin delta use for ovarian stimulation in IVF/ICSI cycles. The risk of bias and the overall quality of the evidence was analyzed. All data were extracted and analyzed using the intention-to-treat principle and expressed per woman randomized.
A total of 7 RCTs (1 phase 1 RCT, 2 phase 2 RCTs and 4 phase 3 RCTs) were included in the qualitative analysis, whereas data of three phase 3 RCTs were meta-analyzed. All trials compared personalized recombinant follitropin delta treatment versus conventional recombinant follitropin alfa/beta administration in potentially normo-responder patients who receive ovarian stimulation in GnRH antagonist IVF/ICSI cycles. No difference between two regimens was detected for clinical pregnancy rate [odds ratio (OR) 1.06; 95% confidence intervals (CI): 0.90, 1.24; P = 0.49; I = 26%], ongoing pregnancy rate (OR 1.15; 95%CI: 0.90, 1.46; P = 0.27; I = 40%), and live birth rate (OR 1.18; 95%CI: 0.89, 1.55; P = 0.25; I = 55%). No data were available regarding cumulative success rates. The rate of adoption of strategies to prevent ovarian hyperstimulation syndrome (OHSS) development (OR 0.45; 95%CI: 0.30, 0.66; P < 0.0001; I = 0%), and the rate of both early OHSS (OR 0.62; 95%CI: 0.43, 0.88; P = 0.008; I = 0%) and all forms of OHSS (OR 0.61; 95%CI: 0.44, 0.84; P = 0.003; I = 0%) were significantly lower in the group of patients treated with personalized follitropin delta treatment compared to those treated with conventional follitropin alfa/beta administration.
Personalized follitropin delta treatment is associated with a lower risk of OHSS compared to conventional follitropin alfa/beta administration in potentially normo-responder patients who receive ovarian stimulation in GnRH antagonist IVF/ICSI cycles. The absence of cumulative data does not allow definitive conclusions to be drawn regarding the comparison of the effectiveness of the two treatments.
CRD42023470352 (available at http://www.crd.york.ac.uk/PROSPERO ).
Follitropin delta 是一种新型重组促卵泡激素制剂，通过重组 DNA 技术在人胎儿视网膜细胞系中独特表达。迄今为止，尚无关于 follitropin delta 的安全性和疗效的系统评价。本研究旨在系统评价现有文献，并提供更新的证据，比较 follitropin delta 与其他促性腺激素制剂在体外受精（IVF）和卵胞浆内单精子注射（ICSI）周期中的卵巢刺激的疗效-安全性概况。
对已发表的关于 follitropin delta 用于 IVF/ICSI 周期卵巢刺激的 1 期、2 期和 3 期 RCT 进行了广泛的搜索。分析了偏倚风险和证据的总体质量。所有数据均采用意向治疗原则提取和分析，并按随机分配的妇女进行表示。
共有 7 项 RCT（1 项 1 期 RCT、2 项 2 期 RCT 和 4 项 3 期 RCT）被纳入定性分析，而 3 项 3 期 RCT 的数据则进行了荟萃分析。所有试验均比较了潜在的正常反应者患者在 GnRH 拮抗剂 IVF/ICSI 周期中接受卵巢刺激时，个体化重组 follitropin delta 治疗与常规重组 follitropin alfa/beta 给药的情况。两种方案在临床妊娠率[优势比（OR）1.06；95%置信区间（CI）：0.90，1.24；P=0.49；I=26%]、持续妊娠率（OR 1.15；95%CI：0.90，1.46；P=0.27；I=40%）和活产率（OR 1.18；95%CI：0.89，1.55；P=0.25；I=55%）方面无差异。关于累积成功率的数据不可用。预防卵巢过度刺激综合征（OHSS）发展的策略的采用率（OR 0.45；95%CI：0.30，0.66；P<0.0001；I=0%）和早期 OHSS（OR 0.62；95%CI：0.43，0.88；P=0.008；I=0%）和所有形式的 OHSS（OR 0.61；95%CI：0.44，0.84；P=0.003；I=0%）的发生率均显著低于接受常规 follitropin alfa/beta 治疗的患者。
在接受 GnRH 拮抗剂 IVF/ICSI 周期卵巢刺激的潜在正常反应者患者中，个体化 follitropin delta 治疗与常规 follitropin alfa/beta 给药相比，OHSS 的风险较低。由于缺乏累积数据，因此无法对两种治疗方法的有效性进行比较得出明确结论。
CRD42023470352（可在 http://www.crd.york.ac.uk/PROSPERO 获得）。
