Xie Yanqiu, Li Ping, Hao Guimin, Deng Weifen, Zhao Junli, Gao Shanshan, Deng Bingbing, Li Yanping, Deng Min, Yuan Yingying, Fan Qi, Zhang Ningzhen, Zhao Zhiming, Shi Yuhua
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, 510080, China.
Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, 510080, China.
Reprod Biol Endocrinol. 2025 Jul 17;23(1):103. doi: 10.1186/s12958-025-01432-w.
Polycystic ovary syndrome (PCOS) patients typically undergo either an ovulation induction regimen or a programmed regimen for endometrial preparation before frozen embryo transfer (FET). However, the superiority of one approach over the other remains controversial. While previous studies suggest that the letrozole regimen may improve pregnancy outcomes, prospective studies are insufficient. Therefore, we designed a multi-center randomized controlled trial to compare the pregnancy outcomes between these two regimens in PCOS patients undergoing FET.
This multicentre, randomised controlled, open-label trial included 155 PCOS patients from six hospitals in China between September 2022 and February 2024. Patients were randomised into either the letrozole ovulation regimen group (n = 81) or the programmed regimen group (n = 74) during FET cycles. Subgroup analysis was used among patients with single blastocyst transfer. The primary outcome was clinical pregnancy rate, with secondary outcomes including abortion rate, live birth rate, and other pregnancy and neonatal outcomes.
Analysis of 155 FET women showed no significant difference in clinical pregnancy rates between the letrozole group (62.96%) and the programmed group (60.81%, P > 0.05). Similarly, no differences were observed in abortion rate, live birth rate, hypertensive disorders of pregnancy, gestational diabetes mellitus, preterm birth, or neonatal birth weight. However, more patients in the letrozole group received single-drug luteal support (53.16% vs. 16.67%, P < 0.05). A subgroup analysis of 108 women involving patients who underwent single blastocyst transfer revealed no significant differences in clinical pregnancy rates (66.67% vs. 73.33%, P > 0.05) or live birth rates (58.73% vs. 55.56%, P > 0.05) between the two groups. A higher proportion of women in the letrozole ovulation regimen group received single-drug luteal support compared to those in the programmed regimen group (58.73% vs. 22.22%, P < 0.05). No statistically significant differences were observed between the groups in terms of fertilization method, abortion rate, or obstetric and neonatal outcomes.
The letrozole ovulation regimen demonstrated comparable clinical pregnancy rates to the programmed regimen in PCOS patients undergoing FET, while requiring only simple luteal support. These findings suggest that the letrozole regimen may be a favourable alternative for endometrial preparation in this population.
Chinese Clinical Trial Registry ChiCTR2200062244 ( https://www.chictr.org.cn ). Registered on 31 July 2022.
多囊卵巢综合征（PCOS）患者在冻融胚胎移植（FET）前，通常采用促排卵方案或程序化方案进行子宫内膜准备。然而，两种方法哪种更具优势仍存在争议。虽然先前的研究表明来曲唑方案可能会改善妊娠结局，但前瞻性研究并不充分。因此，我们设计了一项多中心随机对照试验，比较这两种方案在接受FET的PCOS患者中的妊娠结局。
这项多中心、随机对照、开放标签试验纳入了2022年9月至2024年2月期间来自中国6家医院的155例PCOS患者。在FET周期中，患者被随机分为来曲唑促排卵方案组（n = 81）或程序化方案组（n = 74）。对单囊胚移植患者进行亚组分析。主要结局是临床妊娠率，次要结局包括流产率、活产率以及其他妊娠和新生儿结局。
对155例接受FET的女性进行分析显示，来曲唑组（62.96%）和程序化组（60.81%）的临床妊娠率无显著差异（P>0.05）。同样地，在流产率、活产率、妊娠高血压疾病、妊娠期糖尿病、早产或新生儿出生体重方面也未观察到差异。然而，来曲唑组更多患者接受单药黄体支持（53.16%对16.67%，P<0.05）。对108例接受单囊胚移植患者的亚组分析显示，两组的临床妊娠率（66.67%对73.33%，P>0.05）或活产率（58.73%对55.5%，P>0.05）无显著差异。与程序化方案组相比，来曲唑促排卵方案组接受单药黄体支持的女性比例更高（58.73%对22.22%，P<0.05）。两组在受精方式、流产率或产科和新生儿结局方面未观察到统计学显著差异。
在接受FET的PCOS患者中，来曲唑促排卵方案的临床妊娠率与程序化方案相当，但仅需简单的黄体支持。这些结果表明，来曲唑方案可能是该人群子宫内膜准备的一个有利选择。
中国临床试验注册中心ChiCTR2200062244（https://www.chictr.org.cn）。于2022年7月31日注册。
