Pregnancy outcome and cost-effectiveness comparisons of artificial cycle-prepared frozen embryo transfer with or without GnRH agonist pretreatment for polycystic ovary syndrome: a randomised controlled trial
Pregnancy outcome and cost-effectiveness comparisons of artificial cycle-prepared frozen embryo transfer with or without GnRH agonist pretreatment for polycystic ovary syndrome: a randomised controlled trial
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人工周期准备冷冻胚胎移植（有或没有 GnRH 激动剂预处理）治疗多囊卵巢综合征的妊娠结局和成本效果比较：一项随机对照试验
DOI：
10.1111/1471-0528.16461
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发表时间：
2020-09-06
影响因子：
5.8
通讯作者：
Wang, Q.
中科院分区：
文献类型：
--
作者：
Luo, L.;Chen, M.;Wang, Q.
目的 比较多囊卵巢综合征（PCOS）女性接受或不接受 GnRH 激动剂（GnRH-a）预处理的人工周期冷冻胚胎移植（AC-FET）的活产率和成本效益。设计开放标签、随机、对照试验。设置大学附属医院生殖中心。样本 总共 343 名患有 PCOS 的女性，年龄 24-40 岁，计划接受 AC-FET 并且接受不超过两个囊胚。方法预处理组（n = 172）接受GnRH-a预处理，对照组（n = 171）不接受GnRH-a预处理。分析遵循意向治疗（ITT）原则。主要结局指标 主要结局指标是活产率。次要结局指标包括临床妊娠率、着床率、早期妊娠流产率和每个 FET 周期的直接治疗费用。结果 在随机分组的 343 名女性中，330 名 (96.2%) 接受了胚胎移植，328 名 (95.6%) 完成了方案。根据 ITT 的活产率在治疗前组和对照组之间没有差异 [85/172 (49.4%) 与 92/171 (53.8%)，绝对率差异 -4.4%，95% CI -10.8% 至 2.0% (P = 0.45)。植入率、临床妊娠率和早期妊娠流产率在各组之间也没有差异，但每个 FET 周期的中位直接费用在预处理组中显着较高（7799.2 元 vs 4438.9 元，OR = 1.9，95%CI 1.2-3.4，P < 0.001）。预处理组每活产的中位直接成本也显着较高（15663.1 元 vs 8189.9 元，比值比 [OR] = 1.9，95% CI 1.2-3.8，P < 0.001）。结论 GnRH-a 预处理并不能改善接受 AC-FET 的 PCOS 女性的妊娠结局，但会显着增加患者费用。对于患有 PCOS 的女性，采用 GnRH 激动剂预处理的人工周期制备的 FET 不会提供妊娠结局益处，但会产生更高的成本。
Objective To compare the live birth rate and cost effectiveness of artificial cycle-prepared frozen embryo transfer (AC-FET) with or without GnRH agonist (GnRH-a) pretreatment for women with polycystic ovary syndrome (PCOS). Design Open-label, randomised, controlled trial. Setting Reproductive centre of a university-affiliated hospital. Sample A total of 343 women with PCOS, aged 24-40 years, scheduled for AC-FET and receiving no more than two blastocysts. Methods The pretreatment group (n = 172) received GnRH-a pretreatment and the control group (n = 171) did not. Analysis followed the intention-to-treat (ITT) principle. Main outcome measures The primary outcome measure was live birth rate. Secondary outcome measures included clinical pregnancy rate, implantation rate, early pregnancy loss rate and direct treatment costs per FET cycle. Results Among the 343 women randomised, 330 (96.2%) underwent embryo transfer and 328 (95.6%) completed the protocols. Live birth rate according to ITT did not differ between the pretreatment and control groups [85/172 (49.4%) versus 92/171 (53.8%), absolute rate difference -4.4%, 95% CI -10.8% to 2.0% (P = 0.45). Implantation rate, clinical pregnancy rate and early pregnancy loss rate also did not differ between groups, but median direct cost per FET cycle was significantly higher in the pretreatment group (7799.2 versus 4438.9 RMB, OR = 1.9, 95%CI 1.2-3.4,P < 0.001). Median direct cost per live birth was also significantly higher in the pretreatment group (15663.1 versus 8189.9 RMB, odds ratio [OR] = 1.9, 95% CI 1.2-3.8,P < 0.001). Conclusions Pretreatment with GnRH-a does not improve pregnancy outcomes for women with PCOS receiving AC-FET, but significantly increases patient cost. Tweetable abstract For women with PCOS, artificial cycle-prepared FET with GnRH agonist pretreatment provides no pregnancy outcome benefit but incurs higher cost.