重组 LH 补充治疗对卵巢反应不良患者与单独使用 FSH 相比累积活产率的影响：一项大型真实世界研究。
Effect of recombinant LH supplementation on cumulative live birth rate compared with FSH alone in poor ovarian responders: a large, real-world study.
机构信息
Clinique La Sagesse, Rennes, France.
Centre Hospitalier Inter-communal, Créteil, France.
出版信息
Reprod Biomed Online. 2021 Mar;42(3):546-554. doi: 10.1016/j.rbmo.2020.08.035. Epub 2020 Aug 29.
RESEARCH QUESTION
The benefit of LH supplementation (LHS) over sole use of FSH during controlled ovarian stimulation (COS) remains controversial. Meta-analyses have provided some evidence that the benefit of LHS is limited to women with poor ovarian response (POR). This study aimed to assess the effectiveness of LHS on cumulative live birth rate (CLBR) in POR using a large controlled study in a real-world context.
DESIGN
This retrospective multicentre controlled study used data from registries at 12 French ART centres. All instances of POR undergoing ovarian stimulation and treated with follitrophin-alfa (FSH-α) with or without lutrophin-α were selected following an intention-to-treat principle. POR was defined according to the ESHRE Bologna criteria, and classified into three categories (Mild, Moderate and Severe) according to the Poor Responder Outcome Prediction (PROsPeR) score. The primary end-point was the CLBR associated with fresh and frozen embryos originating from the same ovarian stimulation.
RESULTS
A total of 9787 instances of ovarian stimulation (5218 LHS, 4569 FSH-α only) were analysed, 33.0%, 52.4% and 14.6% being allocated to the Mild, Moderate and Severe PROsPeR categories, respectively. Using a mixed logistic model and adjusting for matched subclasses and baseline POR severity, it was found that the benefit of LHS compared with use of FSH alone differed between baseline severity categories (interaction test, P = 0.007): a significant benefit of LHS for CLBR was found for patients in the Moderate (14.3% versus 11.3%, odds ratio [OR] = 1.37, 95% confidence interval [CI] 1.07-1.75, risk ratio [RR] = 1.29, P = 0.013) and Severe (9.8% versus 4.4%, OR = 2.40, 95% CI- 1.48-3.89, RR = 1.89, P < 0.001) categories, but not for the Mild category (18.8% versus 19.6%, OR = 0.95, 95% CI 0.78-1.15, RR = 0.95, P = 0.60).
CONCLUSION
LHS has a significant effect on increasing CLBR in moderately and severely poor ovarian responders.
研究问题
在控制性卵巢刺激（COS）期间，LH 补充（LHS）相对于单独使用 FSH 的益处仍存在争议。荟萃分析提供了一些证据表明，LHS 的益处仅限于卵巢反应不良（POR）的女性。本研究旨在使用真实世界背景下的大型对照研究评估 LHS 对 POR 累积活产率（CLBR）的有效性。
设计
这是一项回顾性多中心对照研究，使用了来自法国 12 个 ART 中心的注册数据。所有 POR 患者接受 follitrophin-alfa（FSH-α）治疗，无论是否使用 lutrophin-α，均按照意向治疗原则进行选择。POR 根据 ESHRE Bologna 标准定义，并根据 Poor Responder Outcome Prediction（PROsPeR）评分分为三类（轻度、中度和重度）。主要终点是与同一卵巢刺激产生的新鲜和冷冻胚胎相关的 CLBR。
结果
共分析了 9787 例卵巢刺激（5218 例 LHS，4569 例仅用 FSH-α），分别有 33.0%、52.4%和 14.6%分配到轻度、中度和重度 PROsPeR 类别。使用混合逻辑模型并调整匹配亚类和基线 POR 严重程度，发现 LHS 与单独使用 FSH 相比的益处因基线严重程度类别而异（交互检验，P=0.007）：在中度（14.3%比 11.3%，优势比[OR] = 1.37，95%置信区间[CI] 1.07-1.75，风险比[RR] = 1.29，P=0.013）和重度（9.8%比 4.4%，OR = 2.40，95%CI-1.48-3.89，RR = 1.89，P<0.001）类别中，LHS 对 CLBR 的益处显著，但在轻度类别中则不然（18.8%比 19.6%，OR = 0.95，95%CI 0.78-1.15，RR = 0.95，P=0.60）。
结论
LHS 对中度和重度 POR 患者的 CLBR 有显著的提高作用。
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