Recombinant follicle-stimulating hormone (follitropin alfa) for ovulation induction in Japanese patients with anti-estro
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ORIGINAL ARTICLE
Recombinant follicle-stimulating hormone (follitropin alfa) for ovulation induction in Japanese patients with anti-estrogen-ineffective oligo- or anovulatory infertility: results of a phase II dose–response study Yuji Taketani • Eduardo Kelly • Yasunori Yoshimura • Hiroshi Hoshiai • Minoru Irahara • Hideki Mizunuma • Hidekazu Saito • Kazumichi Andoh Zourab Bebia • Takumi Yanaihara
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Received: 6 November 2009 / Accepted: 27 November 2009 / Published online: 23 December 2009 Ó Japan Society for Reproductive Medicine 2009
EMD Serono, Inc., Merck Serono Co., Ltd., Japan, and Merck Serono S.A.-Geneva, Switzerland are affiliates of Merck KGaA, Darmstadt, Germany.
starting doses of r-hFSH of 37.5 IU (group L; n = 62), 75 IU (group M; n = 62) or 150 IU (group H; n = 60). Primary endpoint was time to achieve a dominant follicle with mean diameter C18 mm. Secondary endpoints included percentage of patients producing a dominant follicle C18 mm, achieving ovulation, and biochemical pregnancy. Results Median time to achieve a dominant follicle C18 mm was 14 days (group L; 87.7%), 10 days (group M; 98.4%), and 8 days (group H; 94.5%). In group M, ovulation occurred in 95.1% of patients, with pregnancy in 18.0%, compared with 86.0% and 15.8% in group L, and 50.9% and 9.1% in group H, respectively. Twelve patients developed ovarian hyperstimulation syndrome (nine in
Y. Taketani Department of Obstetrics and Gynecology, Graduate School of Medicine, Faculty of Medicine, University of Tokyo, Tokyo, Japan
H. Saito Division of Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan
E. Kelly EMD Serono, Inc., Rockland, MA, USA
K. Andoh Department of Gynecology, Japanese Red Cross Medical Center, Tokyo, Japan
Abstract Purpose To determine the optimal regimen of recombinant human follicle-stimulating hormone (r-hFSH) for ovulation induction (OI) in Japanese women with amenorrhea I or anovulatory infertility. Methods In this randomized, double-blind, dose-finding study, women aged 20–39 years were enrolled. Patients underwent a chronic low-dose step-up regimen with
On behalf of the Japanese r-hFSH Ovulation Induction study group.
Y. Yoshimura Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo, Japan H. Hoshiai Department of Obstetrics and Gynecology, School of Medicine, Kinki University, Osaka-Sayama, Japan M. Irahara Department of Obstetrics and Gynecology, The University of Tokushima Faculty of Medicine, Tokushima, Japan
Z. Bebia (&) Merck Serono S.A.-Geneva, 11 Chemin des Mines, 1202 Geneva, Switzerland e-mail: [email protected] T. Yanaihara Department of Obstetrics and Gynecology, Showa University School of Medicine, Tokyo, Japan Present Address: E. Kelly Steptoe Therapeutics, Inc., Hingham, MA, USA
H. Mizunuma Department of Obstetrics and Gynecology, School of Medicine, Hirosaki University, Hirosaki, Japan
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Reprod Med Biol (2010) 9:91–97
group H). Most adverse events in groups L and M were mild in severity. Conclusions A st
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