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

Andreas Obruca, Michael Schenk, Gernot Tews, Tonko Mardešić, Milan Mrázek, Helle Meinertz, Bernard Hedon, Paul Barrière, Chunghoon Kim, Mikyoung Koong, Taeki Yoon, Katarzyna Koziol, Waldemar Kuczynski, Rafael Bernabeu, Jose Antonio Ruiz Balda, Christina Bergh, Torbjörn Hillensjö, Hong Yuan Huang, Yu Shih Yang, Ellemiek Von MauwJolanda Elbers, Han Witjes, Anthe S. Zandvliet, Bernadette Mannaerts*

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

87 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)66-76
Number of pages11
JournalReproductive BioMedicine Online
Volume21
Issue number1
DOIs
StatePublished - 07 2010
Externally publishedYes

Keywords

  • IVF
  • body weight
  • corifollitropin alfa
  • follicle stimulant
  • ovarian stimulation
  • sustained

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