OBJECTIVE: To compare the efficacy and safety of the fixed-dose, the step-down, and the low-dose step-up regimens of hMG for women with polycystic ovary syndrome (PCOS). DESIGN: Prospective randomized study. SETTING:Gunma University School of Medicine, Maebashi, Japan. PATIENT(S): Thirty-seven women with PCOS. INTERVENTION(S): The fixed-dose, the step-down. and the low-dose step-up regimens were administered. MAIN OUTCOME MEASURE(S): The number of growing follicles and serum hormone levels. RESULT(S): Serum FSH levels on the day of hCG administration were significantly higher in the fixed-dose regimen group than in the step-down and the low-dose step-up regimen groups, and the number of growing follicles (> or =11 mm) in the low-dose step-up regimen group was significantly smaller than in the fixed-dose regimen group. On the 7th day after hCG administration, the maximal diameter of the ovaries in the low-dose step-up regimen group was significantly smaller than in the fixed-dose and the step-down regimen groups, and the risk of excessive ovarian enlargement (> or =70 mm) was significantly lower in the low-dose step-up regimen group than in the fixed-dose regimen group. CONCLUSION: The low-dose step-up regimen of hMG for patients with PCOS may be the safest protocol among the three stimulation regimens for reducing multiple follicular development.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of the fixed-dose, the step-down, and the low-dose step-up regimens of hMG for women with polycystic ovary syndrome (PCOS). DESIGN: Prospective randomized study. SETTING: Gunma University School of Medicine, Maebashi, Japan. PATIENT(S): Thirty-seven women with PCOS. INTERVENTION(S): The fixed-dose, the step-down. and the low-dose step-up regimens were administered. MAIN OUTCOME MEASURE(S): The number of growing follicles and serum hormone levels. RESULT(S): Serum FSH levels on the day of hCG administration were significantly higher in the fixed-dose regimen group than in the step-down and the low-dose step-up regimen groups, and the number of growing follicles (> or =11 mm) in the low-dose step-up regimen group was significantly smaller than in the fixed-dose regimen group. On the 7th day after hCG administration, the maximal diameter of the ovaries in the low-dose step-up regimen group was significantly smaller than in the fixed-dose and the step-down regimen groups, and the risk of excessive ovarian enlargement (> or =70 mm) was significantly lower in the low-dose step-up regimen group than in the fixed-dose regimen group. CONCLUSION: The low-dose step-up regimen of hMG for patients with PCOS may be the safest protocol among the three stimulation regimens for reducing multiple follicular development.