Department of Reproductive Medicine, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
Reproductive Medicine Centre, Shenzhen Hengsheng Hospital, Shenzhen, China.
Trials. 2024 Jun 6;25(1):364. doi: 10.1186/s13063-024-08164-z.
Women with polycystic ovary syndrome (PCOS) are usually selected to undergo an ovulation induction regimen or a programmed regimen for endometrial preparation in the frozen-thawed embryo transfer (FET) during their IVF/ICSI treatment. The programmed regimen permits flexible scheduling of embryo transfer but requires long-term usage of exogenous estrogen and higher dosages of luteal support while the letrozole ovulation regimen needs lower dosages of luteal support only. Recently, multiple studies have shown that the letrozole ovulation regimen can improve pregnancy outcomes of FET in women with PCOS compared with the programmed regimen. However, most of these studies are retrospective, and prospective studies are urgently needed the evidence from the perspective study is insufficient.
METHODS/DESIGN: We are undertaking a multicentre, randomized, controlled clinical trial of an endometrial preparation regimen for FET in women with PCOS. The eligible women are randomly assigned to either the letrozole ovulation regimen or the programmed regimen for endometrial preparation. The primary outcome is the clinical pregnancy rate.
The results of this study will provide evidence for whether the letrozole ovulation regimen for endometrial preparation could improve pregnancy outcomes in PCOS women undergoing FET.
Chinese Clinical Trial Registry ChiCTR2200062244. Registered on 31 July 2022.
多囊卵巢综合征（PCOS）患者在接受体外受精/卵胞浆内单精子注射（IVF/ICSI）治疗时，通常会选择进行排卵诱导方案或程序化方案以准备子宫内膜，用于冻融胚胎移植（FET）。程序化方案允许灵活安排胚胎移植，但需要长期使用外源性雌激素和更高剂量的黄体支持，而来曲唑排卵方案仅需要较低剂量的黄体支持。最近，多项研究表明，与程序化方案相比，来曲唑排卵方案可以提高 PCOS 患者 FET 的妊娠结局。然而，这些研究大多是回顾性的，迫切需要前瞻性研究提供证据，目前从观察性研究中获得的证据还不足。
方法/设计：我们正在进行一项多中心、随机、对照临床试验，以评估 PCOS 患者 FET 中子宫内膜准备方案。合格的患者被随机分配到来曲唑排卵方案或程序化方案进行子宫内膜准备。主要结局是临床妊娠率。
该研究的结果将为来曲唑排卵方案是否可以改善 PCOS 患者 FET 的妊娠结局提供证据。
中国临床试验注册中心 ChiCTR2200062244. 于 2022 年 7 月 31 日注册。
