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Crinone Gel for Luteal Phase Support in Frozen-Thawed Embryo Transfer Cycles: A Prospective Randomized Clinical Trial in the Chinese Population

机译：知乎的凝胶用于冷冻解冻的胚胎移植周期中的黄体期支持：在中国人口中的前瞻性随机临床试验。

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To compare Crinone vaginal progesterone gel with intramuscularly injected progesterone for luteal phase support in progesterone-supplemented frozen-thawed embryo transfer (FET) cycles, a randomized prospective study of patients qualified for FET was conducted between September 2010 and January 2013 at a hospital in Shanghai, China. From the day of transformation into secretory phase endometrium (day 0), Crinone vaginal gel (90 mg/d) was administered to patients in the Gel Group, while progesterone (40 mg/d) was injected intramuscularly in patients in the Inj Group (n = 750 per group). All patients received oral dydrogesterone (20 mg/d) and estradiol valerate (4–8 mg/d). Day 3 embryos with the highest pre-frozen scores were transferred to patients in the two groups and the clinical outcomes compared. This study comprised 1,500 cycles (750 in each group). Twenty-nine cycles in the Gel Group and 24 in the Inj Group were withdrawn. There were no significant differences between groups in age, endometrial thickness, endometrial preparation time or number of embryos transferred. No significant differences were observed between the Gel Group and Inj Group in the rates of live birth (32.6% vs. 31.7%, P = 0.71), clinical pregnancy (40.1% vs. 40.6%, P = 0.831), implantation (25.8% vs. 25.3%, P = 0.772), abortion (16.3% vs. 18.3%, P = 0.514) or ectopic pregnancy (2.8% vs. 4.4%, P = 0.288). Multivariate logistic regression analysis revealed that the odds ratios (95% confidence intervals) for the rates of live birth, clinical pregnancy, abortion and ectopic pregnancy (Gel Group relative to Inj Group) were 1.036 (0.829–1.295), 0.971 (0.785–1.200), 0.919 (0.595–1.420) and 0.649 (0.261–1.614), respectively. Our study revealed that using Crinone vaginal gel in FET cycles achieved similar pregnancy outcomes to intramuscular progesterone, indicating that vaginal gel is a viable alternative to intramuscular injection.Trial RegistrationChinese Clinical Trial Registry
机译：为了比较可丽酮阴道孕酮凝胶剂与肌注黄体酮在黄体酮补充的冻融胚胎移植（FET）周期中对黄体期支持的作用，于2010年9月至2013年1月在上海一家医院进行了符合FET资格的患者的随机前瞻性研究。 ，中国。从转化为分泌期子宫内膜的那一天（第0天）开始，对Gel组的患者施用Crinone阴道凝胶（90 mg / d），而对Inj组的患者进行肌注黄体酮（40 mg / d）（每组n = 750）。所有患者均口服口服屈屈孕酮（20 mg / d）和戊酸雌二醇（4-8 mg / d）。将冷冻前得分最高的第3天胚胎转移到两组患者中，并比较临床结果。这项研究包括1,500个周期（每组750个）。撤回了凝胶组的29个周期和注射组的24个周期。两组之间的年龄，子宫内膜厚度，子宫内膜制备时间或转移的胚胎数量均无显着差异。 Gel组和Inj组之间在活产率（32.6％对31.7％，P = 0.71），临床妊娠（40.1％对40.6％，P = 0.831），植入（25.8％）方面无显着差异。 vs. 25.3％，P = 0.772），流产（16.3％vs. 18.3％，P = 0.514）或异位妊娠（2.8％vs. 4.4％，P = 0.288）。多元逻辑回归分析显示，活产，临床妊娠，流产和异位妊娠（Gel组相对于Inj组）发生率的比值比（95％置信区间）为1.036（0.829–1.295），0.971（0.785–1.200） ），0.919（0.595–1.420）和0.649（0.261–1.614）。我们的研究表明，在FET周期中使用Crinone阴道凝胶可达到与肌内孕酮相似的妊娠结局，这表明阴道凝胶可替代肌肉内注射。

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