https://scholars.lib.ntu.edu.tw/handle/123456789/460292
標題: | Corifollitropin alfa for ovarian stimulation in IVF: A randomized trial in lower-body-weight women | 作者: | Obruca, Andreas Schenk, Michael Tews, Gernot Mardešić, Tonko Mrázek, Milan Meinertz, Helle Hedon, Bernard Barrière, Paul Kim, Chunghoon Koong, Mikyoung Yoon, Taeki Koziol, Katarzyna Kuczynski, Waldemar Bernabeu, Rafael Ruiz Balda, Jose Antonio Bergh, Christina Hillensjö, Torbjörn Huang, Hong-Yuan YU-SHIH YANG Mauw, Ellemiek Von Elbers, Jolanda Witjes, Han Zandvliet, Anthe S Mannaerts, Bernadette |
公開日期: | 2010 | 卷: | 21 | 期: | 1 | 起(迄)頁: | 66-76 | 來源出版物: | Reproductive BioMedicine Online | 摘要: | In this double-blind, double-dummy, randomized, equivalence trial (Ensure), 396 women weighing 60 kg or less who underwent controlled ovarian stimulation prior to IVF or intracytoplasmic sperm injection were randomized in a 2:1 ratio to a single dose of 100 μg corifollitropin alfa or daily 150 IU recombinant FSH (rFSH) for the first 7 days of stimulation in a gonadotrophin-releasing hormone antagonist protocol. The mean ± SD number of oocytes retrieved per started cycle was 13.3 ± 7.3 for corifollitropin alfa versus 10.6 ± 5.9 for rFSH. The estimated treatment difference of +2.5 oocytes (95% CI 1.2-3.9) in favour of corifollitropin alfa (P < 0.001) was well within the predefined equivalence margin. The median (range) duration of stimulation was 9 (6-15) days in both groups. In 32.8% of the patients, one injection of corifollitropin alfa was sufficient to reach the human chorionic gonadotrophin criterion. The incidence of moderate and severe ovarian hyperstimulation syndrome was 3.4% for corifollitropin alfa and 1.6% for rFSH. A dose of 100 μg corifollitropin alfa offers a simplified treatment option for potential normal responder patients with a lower body weight. ? 2010, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved. |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/460292 | ISSN: | 1472-6483 | DOI: | 10.1016/j.rbmo.2010.03.019 | SDG/關鍵字: | chorionic gonadotropin; corifollitropin alfa; fertility promoting agent; follistim pen; ganirelix; gonadorelin antagonist; placebo; progesterone; recombinant follitropin; recombinant hormone; unclassified drug; adult; antepartum hemorrhage; article; body weight; clinical protocol; clinical trial; controlled clinical trial; controlled study; double blind procedure; drug blood level; drug dose increase; drug dose reduction; drug efficacy; drug elimination; drug half life; drug hypersensitivity; drug induced headache; drug safety; ectopic pregnancy; embryo transfer; female; female infertility; fertilization in vitro; hormonal regulation; hormonal therapy; human; injection; injection site reaction; intracytoplasmic sperm injection; major clinical study; menstrual cycle; multicenter study; oocyte; oocyte retrieval; ovarian stimulation; ovary hyperstimulation; pelvic discomfort; pelvis pain syndrome; randomized controlled trial; single drug dose; time to maximum plasma concentration; treatment duration; treatment outcome |
顯示於: | 醫學系 |
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