Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women

被引:63
|
作者
Obruca, Andreas [1 ]
Tews, Gernot [3 ]
Mardesic, Tonko [4 ]
Mrazek, Milan [5 ]
Meinertz, Helle [6 ]
Hedon, Bernard [7 ]
Barriere, Paul [8 ]
Kim, ChungHoon [9 ]
Koong, Mikyoung [10 ]
Yoon, TaeKi [11 ]
Koziol, Katarzyna [12 ]
Kuczynski, Waldemar [13 ]
Bernabeu, Rafael [14 ]
Ruiz Balda, Jose Antonio [15 ]
Bergh, Christina [16 ]
Hillensjo, Torbjorn [17 ]
Huang, Hong-Yuan [18 ]
Yang, Yu-Shih [19 ]
von Mauw, Ellemiek [20 ]
Elbers, Jolanda [20 ]
Witjes, Han [20 ]
Zandvliet, Anthe S. [20 ]
Mannaerts, Bernadette [20 ]
Schenk, Michael [2 ]
机构
[1] Kinderwunschzentrum Privatspital Goldenes Kreuz, Vienna, Austria
[2] Kinderwunsch Inst Schenk GmbH, Dobl, Austria
[3] Landes Frauen Und Kinderklin Linz, Linz, Austria
[4] Sanatorium PRONATAL, Prague, Czech Republic
[5] ISCARE IVF AS, Prague, Czech Republic
[6] Hvidovre Univ Hosp, Fertil Clin, Hvidovre, Denmark
[7] Hop Arnaud De Villeneuve, Montpellier, France
[8] Hop De La Mere & De Lenfant, Nantes, France
[9] Asan Med Ctr, Seoul, South Korea
[10] Kwandong Univ, Cheil Gen Hosp, Seoul, South Korea
[11] CHA Gen Hosp, Seoul, South Korea
[12] Przychodnia Lekarska Novum, Warsaw, Poland
[13] Centrum Leczenia Nieplodnosci Malzenskiej Kr, Bialystok, Poland
[14] Inst Bernabeu, Alicante, Spain
[15] Hosp Univ 12 Octubre, Madrid, Spain
[16] Sahlgrenska Universitetssjukhuset, Kvinnoklin, Gothenburg, Sweden
[17] Fertilitetscentrum Carlanderska Sjukhuset, Gothenburg, Sweden
[18] Chang Gung Mem Hosp Linkou, Tao Yuan, Taiwan
[19] Natl Taiwan Univ Hosp, Taipei, Taiwan
[20] Womens Hlth & Endocrine, MSD, Global Clin Res, NL-5340 BH Oss, Netherlands
关键词
body weight; corifollitropin alfa; follicle stimulant; IVF; ovarian stimulation; sustained; IN-VITRO FERTILIZATION; FSH-CTP; RECOMBINANT FSH; LIVE BIRTH; HORMONE; AGONIST; ANTAGONISTS;
D O I
10.1016/j.rbmo.2010.03.019
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
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 mu g 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 mu g corifollitropin alfa offers a simplified treatment option for potential normal responder patients with a lower body weight. (C) 2010, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.
引用
收藏
页码:66 / 76
页数:11
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