在接受辅助生殖技术 (ART) 的不孕妇女中,复合人卵泡刺激激素 (rhFSH) 的现实有效性和安全性:一项韩国全国性队列研究
Joong Yeup Lee1, Eun-Young Choi2,3, Jung Ryeol Lee4,5
1Hamchoon Women's Clinic, Seoul, South Korea.
Clinical pharmacology and therapeutics
|December 2, 2025
概括
这项研究发现,复合性人类卵泡刺激激素 (rhFSH) 的一种类型 - - 叶芽素导致在体外受精-胚胎转移 (IVF-ET) 的女性中获得更多卵细胞和减少卵巢过度刺激综合征 (OHSS). 现实世界的数据支持在ART. rhFSH的有效性和安全性.
科学领域:
- 生殖内分泌学 生殖内分泌学
- 辅助生殖技术 (ART) 是一种辅助生殖技术.
- 药物监督 药物监督 药物监督
背景情况:
- 重组人卵泡刺激激素 (rhFSH) 在辅助生殖技术 (ART) 中广泛用于不孕症治疗.
- 关于不同rhFSH制剂的有效性和安全性的现实世界比较数据有限.
- 了解这些差异对于优化体外受精-胚胎移植 (IVF-ET) 周期中的患者结果至关重要.
研究的目的:
- 为了比较不同类型的rhFSH在现实世界IVF-ET周期中的有效性和安全性.
- 评估结果,如卵细胞检索,怀孕率,活产率和不良事件,包括卵巢过度刺激综合征 (OHSS).
- 为关于rhFSH选择的临床决策提供基于证据的见解.
主要方法:
- 一项使用HIRA索赔数据库 (2016-2021) 的回顾性队列研究.
- 包括10,684名年龄在20-39岁的女性,她们的第一个IVF-ET周期仅使用rhFSH.
- 使用通用线性模型,根据共变量进行调整,对follitropin和其他rhFSH组的有效性和安全性结果进行了比较.
主要成果:
- 接受follitropin的女性更有可能获得≥11个卵细胞 (调整后RR,1.09;95%CI:1.02-1.16)
- 草甘使用与卵巢过度刺激综合征 (OHSS) 的风险较低有关 (调整后RR,0.73;95%CI:0.60-0.90).
- 在该队列中,总体活产率为38.8%,OHSS率为5.9%.
结论:
- 现实世界的证据支持rhFSH在新鲜的试管婴儿周期中的有效性和安全性.
- 与其他rhFSH制剂相比,follitropin可能在增加卵细胞检索和降低OHSS风险方面提供优势.
- 这些发现有助于优化rhFSH选择以改善ART结果.
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