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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

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单位: [1]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Obstet & Gynecol, Guangzhou, Guangdong, Peoples R China [2]Univ Hosp Schleswig Holstein, Dept Gynecol Endocrinol & Reprod Med, Lubeck, Germany [3]Nanjing Med Univ, Affiliated Hosp 1, Clin Ctr Reprod Med, State Key Lab Reprod Med, Nanjing, Jiangsu, Peoples R China [4]Reprod & Genet Hosp Cit Xiangya, Changsha, Hunan, Peoples R China [5]Sun Yat Sen Univ, Affiliated Hosp 6, Reprod Med Res Ctr, Guangzhou, Guangdong, Peoples R China [6]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Reprod Med Ctr, Wuhan, Hubei, Peoples R China [7]Zhengzhou Univ, Affiliated Hosp 1, Ctr Reprod Med, Zhengzhou, Henan, Peoples R China [8]Abbott Labs GmbH, Hannover, Germany [9]Abbott GmbH & Co KG, Max Planck Ring 2, D-65205 Wiesbaden, Germany [10]Abbott Prod Operat AG, Allschwil, Switzerland [11]Karolinska Inst, Dept Womens & Childrens Hlth, Div Obstet & Gynecol, Stockholm, Sweden [12]Brussels Free Univ, Univ Hosp, Ctr Reprod Med, Brussels, Belgium [13]Shandong Univ, Ctr Reprod Med, Jinan, Shandong, Peoples R China
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关键词: Chinese mainland dydrogesterone luteal phase support micronized vaginal progesterone gel IVF randomized clinical trial

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.

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出版当年[2019]版:
大类 | 4 区 医学
小类 | 4 区 内分泌学与代谢 4 区 妇产科学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 内分泌学与代谢 4 区 妇产科学
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出版当年[2018]版:
Q4 OBSTETRICS & GYNECOLOGY Q4 ENDOCRINOLOGY & METABOLISM
最新[2024]版:
Q3 OBSTETRICS & GYNECOLOGY Q4 ENDOCRINOLOGY & METABOLISM

影响因子: 最新[2024版] 最新五年平均 出版当年[2018版] 出版当年五年平均 出版前一年[2017版] 出版后一年[2019版]

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第一作者单位: [1]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Obstet & Gynecol, Guangzhou, Guangdong, Peoples R China
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