{"title":"在接受卵巢刺激体外受精/卵浆内单精子注射的中国妇女个体化给药卵泡素δ的比较临床结果","authors":"Rui Yang, Yunshan Zhang, Xiaoyan Liang, Xueru Song, Zhaolian Wei, Jianqiao Liu, Yezhou Yang, Jichun Tan, Qingxue Zhang, Yingpu Sun, Wei Wang, Weiping Qian, Lei Jin, Shuyu Wang, Yang Xu, Jing Yang, Marie Goethberg, Bernadette Mannaerts, Wen Wu, Zugeng Zheng, Jie Qiao","doi":"10.1186/s12958-022-01016-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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-Müllerian 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%).</p><p><strong>Results: </strong>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 µg (95% CI: 9.3-11.2 µg) was estimated to provide the same number of oocytes retrieved as a starting dose of 150 IU/d of follitropin alfa.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration number: </strong>NCT03296527.</p>","PeriodicalId":520764,"journal":{"name":"Reproductive biology and endocrinology : RB&E","volume":" ","pages":"147"},"PeriodicalIF":0.0000,"publicationDate":"2022-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9531501/pdf/","citationCount":"2","resultStr":"{\"title\":\"Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection.\",\"authors\":\"Rui Yang, Yunshan Zhang, Xiaoyan Liang, Xueru Song, Zhaolian Wei, Jianqiao Liu, Yezhou Yang, Jichun Tan, Qingxue Zhang, Yingpu Sun, Wei Wang, Weiping Qian, Lei Jin, Shuyu Wang, Yang Xu, Jing Yang, Marie Goethberg, Bernadette Mannaerts, Wen Wu, Zugeng Zheng, Jie Qiao\",\"doi\":\"10.1186/s12958-022-01016-y\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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-Müllerian 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%).</p><p><strong>Results: </strong>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 µg (95% CI: 9.3-11.2 µg) was estimated to provide the same number of oocytes retrieved as a starting dose of 150 IU/d of follitropin alfa.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinical trial registration number: </strong>NCT03296527.</p>\",\"PeriodicalId\":520764,\"journal\":{\"name\":\"Reproductive biology and endocrinology : RB&E\",\"volume\":\" \",\"pages\":\"147\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-10-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9531501/pdf/\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Reproductive biology and endocrinology : RB&E\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12958-022-01016-y\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Reproductive biology and endocrinology : RB&E","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12958-022-01016-y","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 2
摘要
背景:比较在中国女性个体化固定剂量方案中使用的促卵泡素δ和常规可调剂量方案中使用的促卵泡素α的疗效和安全性。方法:这是一项随机、多中心、评估盲、非劣效性试验(GRAPE)的亚组分析，包括在中国16家生殖医学诊所招募的759名中国女性(年龄在20-40岁)。妇女按1:1的比例随机分配，根据抗勒氏激素(AMH)和体重接受促卵泡素δ剂量治疗，或根据促性腺激素释放激素(GnRH)拮抗剂方案接受促卵泡素α常规剂量治疗。主要结局是胚胎移植后10-11周的持续妊娠率(非劣效边际-10.0%)。结果:叶酸素δ组378例，α组381例随机暴露。对于正在进行的妊娠，证实了非劣效性，与卵泡素α相比，卵泡素δ的比率为31.0%和25.7%，估计平均差异为5.1%(95%置信区间(CI) -1.3%至11.5%)。两组临床妊娠率(35.4% vs. 31.5%， P = 0.239)和活产率(31.0% vs. 25.5%， P = 0.101)具有可比性。总体而言，个体化的follitropin delta治疗比follitropin alpha治疗获得的卵母细胞更少(10.3±6.2 vs 12.5±7.5)。结论:在中国女性中，与传统的可调剂量方案相比，follitropin delta个体化固定剂量方案具有相似的疗效和更高的安全性。临床试验注册号:NCT03296527。
Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection.
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-Müllerian 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 µg (95% CI: 9.3-11.2 µg) 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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