Recombinant follicle-stimulating hormone (follitropin alfa) versus purified urinary follicle-stimulating hormone in a lo
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ORIGINAL ARTICLE
Recombinant follicle-stimulating hormone (follitropin alfa) versus purified urinary follicle-stimulating hormone in a low-dose step-up regimen to induce ovulation in Japanese women with anti-estrogen-ineffective oligo- or anovulatory infertility: results of a single-blind Phase III study Yuji Taketani • Eduardo Kelly • Yasunori Yoshimura • Hiroshi Hoshiai • Minoru Irahara Hideki Mizunuma • Hidekazu Saito • Kazumichi Andoh • Takumi Yanaihara
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Received: 5 November 2009 / Accepted: 21 December 2009 / Published online: 23 February 2010 Ó Japan Society for Reproductive Medicine 2010
Abstract Purpose We aimed to compare the efficacy and safety of recombinant human follicle-stimulating hormone (follitropin alfa) and purified urinary human follicle-stimulating hormone (urofollitropin) for ovulation induction in Japanese women with anovulatory infertility;also to verify the noninferiority (in terms of ovulation rate) of follitropin alfa versus urofollitropin. Methods In a Phase III, multicenter, single-blind, parallel-group study, we enrolled 265 Japanese women aged 20–39 years. The patients were menstruating without On behalf of the Japanese r-hFSH Ovulation Induction study group. EMD Serono, Inc., Merck Serono Co., Ltd., Japan, and Merck Serono S.A.-Geneva, Switzerland are affiliates of Merck KGaA, Darmstadt, Germany. Y. Taketani Department of Obstetrics and Gynaecology, Graduate School of Medicine, Faculty of Medicine, University of Tokyo, Tokyo, Japan E. Kelly EMD Serono, Inc., Rockland, MA, USA Y. Yoshimura Department of Obstetrics and Gynaecology, School of Medicine, Keio University, Tokyo, Japan H. Hoshiai Department of Obstetrics and Gynaecology, School of Medicine, Kinki University, Osaka-Sayama, Japan M. Irahara Department of Obstetrics and Gynaecology, The University of Tokushima Faculty of Medicine, Tokushima, Japan
apparent ovulation or were amenorrheic (with a positive progestin challenge test), and had failed to conceive with anti-estrogen ovulation-induction therapy. The patients underwent a low-dose step-up regimen using follitropin alfa or urofollitropin with a starting dose of 75 IU. The primary endpoint was the proportion of patients who ovulated (mid-luteal serum progesterone C5 ng/mL and/or confirmed clinical pregnancy). Secondary endpoints included the proportion of patients with a dominant follicle (C18 mm) and the duration of stimulation. Results Ovulation occurred in 79.1% and 82.6% of the patients who received follitropin alfa and urofollitropin, respectively, in the full-analysis set (n = 261), and in 79.2% and 82.5% of the per-protocol set (n = 251). The predefined noninferiority criteria for the primary endpoint were achieved. No significant differences were observed in H. Mizunuma Department of Obstetrics and Gynaecology, School of Medicine, Hirosaki University, Hirosaki, Japan H. Saito (&) Division of Reproductive Medicine, Department of Perinatal Medicine and Maternal Care, National Center for Child Health and Development, Tokyo 157-8535, Japan e-mail: [email protected]
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