Abstract |
In this double-blind, double-dummy, randomized, equivalence trial (Ensure), 396 women weighing 60kg 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 100mug corifollitropin alfa or daily 150IU recombinant FSH (rFSH) for the first 7days 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 100mug corifollitropin alfa offers a simplified treatment option for potential normal responder patients with a lower body weight.
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Authors | Corifollitropin alfa Ensure Study Group |
Journal | Reproductive biomedicine online
(Reprod Biomed Online)
Vol. 21
Issue 1
Pg. 66-76
(Jul 2010)
ISSN: 1472-6491 [Electronic] Netherlands |
PMID | 20483664
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | 2010 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved. |
Chemical References |
- Follicle Stimulating Hormone, Human
- Recombinant Proteins
- follicle stimulating hormone, human, with HCG C-terminal peptide
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Topics |
- Adolescent
- Adult
- Body Weight
- Female
- Fertilization in Vitro
(methods)
- Follicle Stimulating Hormone, Human
(therapeutic use)
- Humans
- Ovulation Induction
(methods)
- Pregnancy
- Pregnancy Rate
- Recombinant Proteins
(therapeutic use)
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