| Autor: |
Adam Balen, Peter Platteau, Anders Nyboe Andersen, Paul Devroey, Lisbeth Helmgaard, Joan-Carles Arce, for the Bravelle Ovulation Induction (BOI) Study Group |
| Předmět: |
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| Zdroj: |
Human Reproduction; Jul2007, Vol. 22 Issue 7, p1816-1816, 1p |
| Abstrakt: |
: BACKGROUND The objective of this study was to demonstrate non-inferiority of a highly purified urinary follicle stimulating hormone (HP-FSH) preparation compared with a recombinant (rFSH) preparation with respect to ovulation rate (primary end-point). : METHODS This was a randomized, open-label, assessor-blind, multinational study. Women with anovulatory infertility WHO Group II and resistant to clomiphene citrate were randomized (computer-generated list) to stimulation with HP-FSH (n = 73) or rFSH (n = 78) using a low-dose step-up protocol. The non-inferiority limit was prespecified at −20%. : RESULTS The ovulation rate was 85.2% (51/62) with HP-FSH and 90.9% (60/66) with rFSH (per-protocol population), and non-inferiority was demonstrated [95% confidence interval: −16.9; 5.6]. No differences were noted between groups in number of follicles ≥12 mm, ≥15 mm or ≥ 18 mm, mono-follicular development, pregnancy rates, endometrial thickness, number of ovarian stimulation syndrome cases or frequency of injection site reactions/pain. The singleton live birth rate was 15% in both groups (11/73 with HP-FSH and 12/78 with rFSH). : CONCLUSIONS This urinary HP-FSH preparation is non-inferior compared with a rFSH preparation with respect to ovulation rate in anovulatory WHO Group II women failing to ovulate or conceive on clomiphene citrate. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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