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使用重组人卵泡刺激素:重组人黄体生成素(r-hFSH:r-hLH)2:1 组合进行辅助生殖技术治疗中的控制性卵巢刺激:俄罗斯联邦常规实践的真实世界研究。

Use of a recombinant human follicle-stimulating hormone:recombinant human luteinizing hormone (r-hFSH:r-hLH) 2:1 combination for controlled ovarian stimulation during assisted reproductive technology treatment: A real-world study of routine practice in the Russian Federation.

机构信息

Department of Obstetrics and Gynecology, Russian Medical Academy of Continuous Professional Education, Centre of Reproduction "Life Line," 121471 Moscow, Russian Federation.

International Centre for Reproductive Medicine (ICRM), Komendantskij prospect, 197350 St Petersburg, Russian Federation.

出版信息

Best Pract Res Clin Obstet Gynaecol. 2022 Dec;85(Pt B):134-148. doi: 10.1016/j.bpobgyn.2022.01.009. Epub 2022 Feb 2.

DOI:10.1016/j.bpobgyn.2022.01.009
PMID:35216907
Abstract

Two observational studies in the Russian Federation described patient demographics/clinical decision for treatment with recombinant human follicle-stimulating hormone:recombinant human luteinizing hormone (r-hFSH:r-hLH) 2:1 combination for ovarian stimulation (OS) during assisted reproductive technology (ART) and outcomes, respectively. The first (prospective) study enrolled 500 patients. After post-hoc regrouping to assign patients to discrete groups, 378 (75.6%) met the local Russian label for an r-hFSH:r-hLH 2:1 combination, 105 (21%) were treated according to other physician preference, and 17 (3.4%) met only the ESHRE Bologna criteria for a poor ovarian response. The clinical pregnancy rate per cycle was 30.4%. A total of 158/175 (90.3%) women achieving clinical pregnancy in the prospective study participated in the second (retrospective) study. The live birth rate per cycle was 25.8%. No new safety concerns were reported. These results support the use of the r-hFSH:r-hLH 2:1 combination in patients with a poor/suboptimal response to OS for ART treatment in the Russian Federation.

摘要

两项在俄罗斯联邦开展的观察性研究分别描述了在辅助生殖技术(ART)中使用重组人卵泡刺激素:重组人黄体生成素(r-hFSH:r-hLH)2:1 组合进行卵巢刺激(OS)的患者特征/治疗决策和结局。第一项(前瞻性)研究纳入了 500 名患者。在进行事后分组以将患者分配到离散组后,378 名(75.6%)符合当地俄罗斯 r-hFSH:r-hLH 2:1 组合的标签,105 名(21%)根据其他医生的偏好进行治疗,17 名(3.4%)仅符合 ESHRE 博洛尼亚的卵巢反应不良标准。每个周期的临床妊娠率为 30.4%。在前瞻性研究中,共有 175 名(90.3%)实现临床妊娠的女性参与了第二项(回顾性)研究。每个周期的活产率为 25.8%。未报告新的安全性问题。这些结果支持在俄罗斯联邦,对 ART 治疗中 OS 反应不良/不佳的患者使用 r-hFSH:r-hLH 2:1 组合。

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