Medical Center for Human Reproduction, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Trials. 2022 Aug 13;23(1):654. doi: 10.1186/s13063-022-06586-1.
The gonadotropin-releasing hormone (GnRH) antagonist protocol is advantageous given that it can avoid severe ovarian hyperstimulation syndrome (OHSS), especially for patients with polycystic ovary syndrome (PCOS). Basic and clinical evidence has shown that a threshold of luteinizing hormone (LH) stimulation is required for adequate follicular development and oocyte maturation. Ultra-low or high levels of LH are detrimental to pregnancy outcomes. We previously demonstrated that LH could be an indicator for the timing and dosage of antagonist administration in a retrospective study.
METHODS/DESIGN: In this randomized, single-center, non-inferiority trial, we aim to test the hypothesis that there is no significant difference in cumulative ongoing pregnancy rates between PCOS patients stimulated with LH-based flexible protocol versus traditional flexible GnRH antagonist protocol. The primary efficacy endpoint will be the cumulative ongoing pregnancy rate per cycle. The secondary outcomes will be clinical pregnancy rate, cancelation rate, serious OHSS rate, and cost-efficiency. The cumulative ongoing pregnancy rate per cycle in PCOS women was 80%. Considering that a non-inferiority threshold should retain 80% of the clinical effect of a control treatment, a minimal clinical difference of 16% (two-sided: α, 2.5%; β, 20%) and a total of 196 patients were needed. Anticipating a 10% dropout rate, the total number of patients required was 216.
The results of this study will provide evidence for the efficacy and safety of the LH-based flexible GnRH antagonist protocol in PCOS patients. Moreover, it evaluates the cost-efficiency of both protocols.
Chinese Clinical Trial Registry ChiCTR1800018129. Date assigned: 31 August 2018.
1.0 (18 July 2017).
促性腺激素释放激素（GnRH）拮抗剂方案具有优势，因为它可以避免严重的卵巢过度刺激综合征（OHSS），特别是对于多囊卵巢综合征（PCOS）患者。基础和临床证据表明，促黄体生成素（LH）刺激的阈值是卵泡发育和卵母细胞成熟所必需的。LH 的超低或超高水平不利于妊娠结局。我们之前的研究表明，在回顾性研究中，LH 可以作为拮抗剂给药时间和剂量的指标。
方法/设计：在这项随机、单中心、非劣效性试验中，我们旨在检验以下假设：在基于 LH 的灵活方案与传统灵活 GnRH 拮抗剂方案刺激的 PCOS 患者中，累积持续妊娠率没有显著差异。主要疗效终点将是每个周期的累积持续妊娠率。次要结局将是临床妊娠率、取消率、严重 OHSS 率和成本效益。PCOS 女性每个周期的累积持续妊娠率为 80%。考虑到非劣效性阈值应保留对照治疗 80%的临床效果，最小临床差异为 16%（双侧：α，2.5%；β，20%），总共需要 196 名患者。预计 10%的脱落率，总共需要 216 名患者。
该研究的结果将为基于 LH 的灵活 GnRH 拮抗剂方案在 PCOS 患者中的疗效和安全性提供证据。此外，它评估了两种方案的成本效益。
中国临床试验注册中心 ChiCTR1800018129。分配日期：2018 年 8 月 31 日。
1.0（2017 年 7 月 18 日）。
