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.

中文翻译：

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与单用 FSH 相比，重组 LH 补充剂对卵巢反应不佳者累积活产率的影响：一项大型真实世界研究

研究问题

在受控卵巢刺激 (COS) 期间，LH 补充剂 (LHS) 比单独使用 FSH 的好处仍然存在争议。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佳 (POR) 的女性。本研究旨在在现实世界中使用大型对照研究来评估 LHS 对 POR 中累积活产率 (CLBR) 的有效性。

设计

这项回顾性多中心对照研究使用了来自 12 个法国 ART 中心注册处的数据。所有接受卵巢刺激并用促卵泡激素-α (FSH-α) 治疗的 POR 实例均按照意向治疗原则进行选择。POR 根据 ESHRE Bologna 标准定义，并根据不良反应者结果预测 (PROsPeR) 评分分为三类（轻度、中度和重度）。主要终点是与源自相同卵巢刺激的新鲜和冷冻胚胎相关的 CLBR。

结果

共分析了 9787 次卵巢刺激（5218 次 LHS，仅 4569 次 FSH-α），分别有 33.0%、52.4% 和 14.6% 被分配到轻度、中度和重度 PROsPeR 类别。使用混合逻辑模型并调整匹配的亚类和基线 POR 严重程度，发现与单独使用 FSH 相比，LHS 的益处在基线严重程度类别之间存在差异（交互测试，P  = 0.007）：LHS 对 CLBR 的显着益处发现中度（14.3% 对 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%）患者对比 4.4%，OR = 2.40，95% CI–1.48–3.89，RR = 1.89，P < 0.001) 类别，但不适用于轻度类别（18.8% 对 19.6%，OR = 0.95，95% CI 0.78–1.15，RR = 0.95，P  = 0.60）。

结论

LHS 对增加中度和严重不良卵巢反应者的 CLBR 有显着影响。