Yuji Taketani1, Eduardo Kelly2,3, Yasunori Yoshimura4, Hiroshi Hoshiai5, Minoru Irahara6, Hideki Mizunuma7, Hidekazu Saito8, Kazumichi Andoh9, Zourab Bebia10, Takumi Yanaihara11. 1. Department of Obstetrics and Gynecology, Graduate School of Medicine, Faculty of Medicine University of Tokyo Tokyo Japan. 2. EMD Serono, Inc. Rockland MA USA. 3. Steptoe Therapeutics, Inc. Hingham MA USA. 4. Department of Obstetrics and Gynecology, School of Medicine Keio University Tokyo Japan. 5. Department of Obstetrics and Gynecology, School of Medicine Kinki University Osaka-Sayama Japan. 6. Department of Obstetrics and Gynecology The University of Tokushima Faculty of Medicine Tokushima Japan. 7. Department of Obstetrics and Gynecology, School of Medicine Hirosaki University Hirosaki Japan. 8. Division of Reproductive Medicine National Center for Child Health and Development Tokyo Japan. 9. Department of Gynecology Japanese Red Cross Medical Center Tokyo Japan. 10. Merck Serono S.A.-Geneva 11 Chemin des Mines 1202 Geneva Switzerland. 11. Department of Obstetrics and Gynecology Showa University School of Medicine 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 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 ≥18 mm. Secondary endpoints included percentage of patients producing a dominant follicle ≥18 mm, achieving ovulation, and biochemical pregnancy. Results:Median time to achieve a dominant follicle ≥18 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 group H). Most adverse events in groups L and M were mild in severity. Conclusions: A starting dose of 75 IU r-hFSH was associated with a favorable efficacy and safety profile for OI in Japanese women.
RCT Entities:
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 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 ≥18 mm. Secondary endpoints included percentage of patients producing a dominant follicle ≥18 mm, achieving ovulation, and biochemical pregnancy. Results: Median time to achieve a dominant follicle ≥18 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. Twelvepatients developed ovarian hyperstimulation syndrome (nine in group H). Most adverse events in groups L and M were mild in severity. Conclusions: A starting dose of 75 IU r-hFSH was associated with a favorable efficacy and safety profile for OI in Japanese women.
Authors: J N Hugues; I Cédrin-Durnerin; C M Howles; M Amram; A Angelini; A Balen; D Barbereau; M Birkhauser; A Boujenah; V De Leo; G De Placido; S Dessole; S Favrin; E Ferrazi; C Gay; M Germond; B Hedon; C Hocke; C Jolly; E Lamarca-Roth; A Lanzone; F Marchand; G Marcolin; G Mascaretti; L Moreau; M Massobrio; C Nappi; G Pardi; G Pennehouat; E Porcu; M Seibert; L Selvaggi; D Thiers; P Venturini Journal: Hum Reprod Date: 2006-07-27 Impact factor: 6.918