Bachground and purpose: The purpose of this study was to determine whether the changes of sex hormone-binding globulin (SHBG) affect the pregnancy outcome in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproductive technology (ART). Methods: Forty-seven infertile women who were undergoing pituitary desensitization and COH for in vitro fertilization (IVF) with or without intracytoplasmic sperm injection (ICSI) and 21 women with normal menstrual (NM) cycles participated in the study. Fasting blood samples of the follicular and luteal phases, including follicular fluid during oocyte retrieval, were obtained for determination of estradiol (E2), progesterone (P), testosterone (T), and SHBG concentrations. Results: The SHBG levels increased progressively through the course of COH, but remained constant throughout NM cycles. A positive correlation existed between E2 and SHBG levels in both the follicular and luteal phases. The mean plasma SHBG concentration and E2IT ratio were significantly higher, while the level of T and the free androgen index (FAT) were significantly lower, in the luteal phase of women who conceived than in those who did not conceive following COH. The changes of follicular fluid SHBG level and E2/T ratio were similar to those in plasma. Conclusion: Increases of SHBG in the follicular and luteal phases may be a reflection of the functional state of ovarian stimulation and further that such elevations may influence the pregnancy outcome through the modulation of circulating estrogen and androgen balance during down-regulated COH cycles for IVF/ICSI.