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Vaginal progesterone gel is non-inferior to intramuscular progesterone in efficacy with acceptable tolerability for luteal phase support: A prospective, randomized, multicenter study in China

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机构: [a]Peking University Third Hospital, IVF Center, No. 49, North Garden Rd., Haidian District, Beijing, 100191, PR China [b]The Affiliated Hospital of Inner Mongolia Medical University, No. 1, North Road, Hohhot, Inner Mongolia, PR China [c]The Third Affiliated Hospital of Zhengzhou University, No. 7, Heping Qianjie, Erqi District, Zhengzhou, Henan Province, PR China [d]The Second Affiliated Hospital of Hebei Medical University, No. 215, Heping West Road, Shijiazhuang, Hebei Province, PR China [e]Jiangxi Maternal and Child Hospital, No. 318, Bayi Avenue, Nanchang, Jiangxi Province, PR China [f]The First Affiliated Hospital of Anhui Medical University, No. 218, Jixi Road, Hefei, Anhui Province, PR China [g]Wuxi Maternal and Child Health Hospital, No. 48, Yushu Lane, Wuxi, Jiangsu Province, PR China [h]Chongqing Health Center for Women and Children, No. 64, Jingtang Street, Qixinggang, Yuzhong District, Chongqing, PR China [i]Women’s Hospital School of Medicine, Zhejiang University, No. 1, Xueshi Road, Hangzhou City, Zhejiang Province, PR China [j]Beijing Obstetrics and Gynecology Hospital, No. 251, Yaojiayuan Road, Chaoyang District, Beijing, PR China [k]The First Affiliated Hospital of Lanzhou University, No. 1, Donggang West Road, Chengguan District, Lanzhou, Gansu Province, PR China [l]Henan Provincial People’s Hospital, No. 7, Weiwu, Zhengzhou, Henan Province, PR China [m]Tianjin Central Hospital of Gynecology Obstetrics, No. 156, Nankai Sanma Road, Tianjin, PR China [n]Sichuan Provincial People’s Hospital, No. 32, West Second Section First Ring Road, Chengdu, Sichuan, PR China [o]The First Affiliated Hospital of Zhengzhou University, No. 1, Jianshe East Road, Zhengzhou, Henan Province, PR China [p]Suzhou Municipal Hospital, No. 26, Daoqian Street, Suzhou, Jiangsu Province, PR China [q]The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang, Ouhai District, Wenzhou, Zhejiang Province, PR China [r]Chengdu Women’s & Children’s Central Hospital, No. 1617, Riyue Avenue, Qingyang District, Chengdu, Sichuan Province, PR China
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关键词: In vitro fertilization Luteal phase support Ongoing pregnancy rate Safety Vaginal progesterone gel

摘要:
Objectives: Research suggests the efficacy of progesterone for luteal phase support in assisted reproduction cycles using gonadotropin-releasing hormone analogues. Our study objective was to compare the efficacy of two available preparations of progesterone, vaginal gel and intramuscular injection, for luteal phase support in assisted reproduction cycles. Study design: This study included data gathered from 18 reproductive centers in China. Subjects were randomly allocated to receive progesterone gel or intramuscular progesterone (IMP). The progesterone gel group received micronized progesterone in gel (8%, 90 mg)once daily; the IMP group received IMP (progesterone oil)once daily. The ongoing pregnancy rate was calculated (number of women with a viable pregnancy at 12 weeks divided by the number of women who had undergone an oocyte pickup cycle). Results: A total of 1313 patients were enrolled in the study, 1248 of whom began treatment. The intention-to-treat set included 527 and 531 patients in the gel and IMP groups, respectively. The ongoing pregnancy rate in the progesterone gel group was non-inferior to that in the IMP group (48.4% [95% confidence interval (CI): 44.0, 52.8]vs. 46.3% [95% CI: 42.0, 50.7]); the between-group rate difference was 2.1% (−4.0, 8.1). There was no difference between the gel group and IMP group on most secondary endpoints, including implantation rate, biochemical pregnancy rate, clinical pregnancy rate, multiple pregnancy rate, early abortion rate, and vaginal bleeding rate, but there was a between-group difference in luteal phase bleeding rate. The safety analysis showed no difference in the incidence of total adverse events. Conclusions: Progesterone gel showed good efficacy and safety outcomes and therefore provides an alternative method of luteal support in Chinese in vitro fertilization patients. © 2019 Elsevier B.V.

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出版当年[2018]版:
大类 | 4 区 医学
小类 | 4 区 妇产科学 4 区 生殖生物学
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 妇产科学 4 区 生殖生物学
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出版当年[2017]版:
Q3 OBSTETRICS & GYNECOLOGY Q3 REPRODUCTIVE BIOLOGY
最新[2023]版:
Q2 OBSTETRICS & GYNECOLOGY Q3 REPRODUCTIVE BIOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

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第一作者机构: [a]Peking University Third Hospital, IVF Center, No. 49, North Garden Rd., Haidian District, Beijing, 100191, PR China
通讯作者:
通讯机构: [a]Peking University Third Hospital, IVF Center, No. 49, North Garden Rd., Haidian District, Beijing, 100191, PR China [*1]Department of Obstetrics and Gynecology, Center for Reproductive Medicine, Peking University Third Hospital, IVF Center, No. 49, North Garden Rd., Haidian District, Beijing, 100191, PR China.
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