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首页> 外文期刊>Gynecological endocrinology: the official journal of the International Society of Gynecological Endocrinology >A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation
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A Phase III randomized controlled trial of oral dydrogesterone versus intravaginal progesterone gel for luteal phase support in in vitro fertilization (Lotus II): results from the Chinese mainland subpopulation

机译:III期随机对照试验的口服莫迪辛酮对体外施肥中患有患者嗜酸性磷酸盐术(Lotus II)的嗜肺磷酸盐凝胶:中国大陆亚贫民的结果

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摘要

Lotus II, a randomized, open-label, multicenter, international study compared the efficacy and safety of oral dydrogesterone versus micronized vaginal progesterone (MVP) gel for luteal support in IVF. A prespecified subgroup analysis was performed on 239 Chinese mainland subjects from the overall study population (n = 1034), who were randomized to oral dydrogesterone 30 mg or 8% MVP gel 90 mg daily from the day of oocyte retrieval until 12 weeks of gestation. The aim was to demonstrate non-inferiority of oral dydrogesterone to MVP gel, assessed by the presence of a fetal heartbeat at 12 weeks of gestation. In the Chinese mainland subpopulation, there was a numerical difference of 9.4% in favor of oral dydrogesterone, with ongoing pregnancy rates at 12 weeks of gestation of 61.4% and 51.9% in the oral dydrogesterone and MVP gel groups, respectively (adjusted difference, 9.4%; 95% CI: -3.4 to 22.1); in the overall population, these were 38.7% and 35%, respectively (adjusted difference, 3.7%; 95% CI: -2.3 to 9.7). In both the Chinese mainland subpopulation and the overall population, dydrogesterone had similar efficacy and safety to MVP gel. With convenient oral administration, dydrogesterone has potential to transform luteal support treatment.
机译:莲花II,随机开放标签,多中心,国际研究比较了口服莫迪辛酮与微粉化阴道孕酮(MVP)凝胶在IVF中的疗效和安全性。从整个研究人群(N = 1034)的239名中国大陆受试者进行预先确定的亚组分析,他从卵母细胞检索的日期到12周的妊娠期从卵母细胞检索的日期中随机化到口服Dydergerone 30mg或8%MVP凝胶90mg。目的是向MVP凝胶的口服莫迪辛酮的非自卑,通过妊娠12周的胎儿心跳的存在评估。在中国大陆亚贫民中,数值差异为10.4%,有利于口服莫迪辛酮,在口服染料酮和MVP凝胶基团的妊娠12周内持续妊娠率和51.9%(调整差异,9.4 %; 95%CI:-3.4至22.1);在整个人口中,这些分别为38.7%和35%(调整差异,3.7%; 95%CI:-2.3至9.7)。在中国大陆亚贫民和整体人群中,莫德替政酮对MVP凝胶具有相似的疗效和安全性。随着口服施用的方便,莫德英酮有潜力转化产褥支撑治疗。

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