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Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection

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单位: [1]Peking Univ Third Hosp, Ctr Reprod Med, Dept Obstet & Gynecol, Beijing, Peoples R China [2]Tianjin Cent Hosp Gynaecol & Obstet, Tianjin, Peoples R China [3]Sun Yat Sen Univ, Affiliated Hosp 6, Guangzhou, Peoples R China [4]Tianjin Med Univ, Gen Hosp, Tianjin, Peoples R China [5]Anhui Med Univ, Affiliated Hosp 1, Hefei, Peoples R China [6]Guangzhou Med Univ, Affiliated Hosp 3, Guangzhou, Peoples R China [7]Sichuan Univ, West China Univ Hosp 2, Chengdu, Sichuan, Peoples R China [8]China Med Univ, ShengJing Hosp, Shenyang, Peoples R China [9]Sun Yat Sen Univ, SunYat Sen Mem Hosp, Guangzhou, Peoples R China [10]Zhengzhou Univ, Affiliated Hosp 1, Zhengzhou, Peoples R China [11]Nanjing Med Univ, Jiangsu Prov Hosp, Affiliated Hosp 1, Nanjing, Peoples R China [12]Peking Univ, Shenzhen Hosp, Shenzhen, Peoples R China [13]HUST, Tongji Hosp, Tongji Med Coll, Wuhan, Peoples R China [14]Capital Med Univ, Beijing Obstet & Gynecol Hosp, Beijing, Peoples R China [15]Peking Univ First Hosp, Beijing, Peoples R China [16]Wuhan Univ, Hubei Gen Hosp, Renmin Hosp, Wuhan, Peoples R China [17]Ferring Pharmaceut, Global Biometr, Copenhagen, Denmark [18]Ferring Pharmaceut, Reprod Med & Maternal Hlth, Copenhagen, Denmark [19]Ferring Pharmaceut, Shanghai, Peoples R China
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关键词: Follitropin delta Algorithm Individualized dosing Ongoing pregnancy Ovarian hyperstimulation syndrome Dose equivalence

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Background To compare the efficacy and safety of follitropin delta in its individualized fixed-dose regimen with follitropin alfa in a conventional adjustable dosing regimen in Chinese women. Methods This was a subgroup analysis of the randomized, multi-center, assessor-blind, non-inferiority trial (GRAPE) including 759 Chinese women (aged 20-40 years) recruited in 16 reproductive medicine clinics in China. Women were randomized in a 1:1 ratio to be treated with either follitropin delta dose based on anti-Mullerian hormone (AMH) and body weight or conventional dosing with follitropin alfa following a gonadotropin-releasing hormone (GnRH) antagonist protocol. The primary outcome was ongoing pregnancy rate assessed 10-11 weeks after embryo transfer in the fresh cycle (non-inferiority margin -10.0%). Results 378 in the follitropin delta group and 381 in the follitropin alfa group were randomized and exposed. Non-inferiority was confirmed with respect to ongoing pregnancy with rates of 31.0% vs. 25.7% for follitropin delta compared to follitropin alfa, estimated mean difference of 5.1% (95% confidence interval (CI) -1.3% to 11.5%). The clinical pregnancy rate (35.4% vs. 31.5%, P = 0.239) and live birth rate (31.0% vs. 25.5%, P = 0.101) were comparable between the follitropin delta group and the follitropin alfa group. Overall, the individualized follitropin delta treatment resulted in fewer oocytes retrieved compared to follitropin alfa treatment (10.3 +/- 6.2 vs. 12.5 +/- 7.5, P < 0.001), which was mainly due to fewer oocytes (10.5 +/- 6.4 vs. 13.9 +/- 7.8) in women with AMH >= 15 pmol/L. Accordingly there was a lower incidence of early ovarian hyper-stimulation syndrome (OHSS) and/or preventive interventions (6.1% vs. 11.0%, P = 0.013). A daily follitropin delta dose of 10.2 mu g (95% CI: 9.3-11.2 mu g) was estimated to provide the same number of oocytes retrieved as a starting dose of 150 IU/d of follitropin alfa. Conclusion Follitropin delta in its individualized fixed-dose regimen showed similar efficacy and improved safety compared with follitropin alfa in a conventional adjustable dosing regimen in Chinese women.

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出版当年[2021]版:
大类 | 2 区 医学
小类 | 2 区 内分泌学与代谢 2 区 生殖生物学
最新[2025]版:
大类 | 2 区 医学
小类 | 1 区 生殖生物学 2 区 内分泌学与代谢
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出版当年[2020]版:
Q1 REPRODUCTIVE BIOLOGY Q1 ENDOCRINOLOGY & METABOLISM
最新[2023]版:
Q1 ENDOCRINOLOGY & METABOLISM Q1 REPRODUCTIVE BIOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

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第一作者单位: [1]Peking Univ Third Hosp, Ctr Reprod Med, Dept Obstet & Gynecol, Beijing, Peoples R China
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