Open AccessRecombinant 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
Author(s) -
Taketani Yuji,
Kelly Eduardo,
Yoshimura Yasunori,
Hoshiai Hiroshi,
Irahara Minoru,
Mizunuma Hideki,
Saito Hidekazu,
Andoh Kazumichi,
Bebia Zourab,
Yanaihara Takumi
Publication year - 2010
Publication title -
reproductive medicine and biology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.005
H-Index - 22
eISSN - 1447-0578
pISSN - 1445-5781
DOI - 10.1007/s12522-009-0044-7
Subject(s) - medicine , ovulation induction , anovulation , ovulation , infertility , follicle stimulating hormone , regimen , pregnancy rate , unexplained infertility , ovarian hyperstimulation syndrome , gynecology , follicle , pregnancy , endocrinology , hormone , luteinizing hormone , polycystic ovary , in vitro fertilisation , biology , diabetes mellitus , insulin resistance , genetics
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.