کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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3933852 | 1253363 | 2009 | 12 صفحه PDF | دانلود رایگان |

ObjectiveTo demonstrate the efficacy and safety of follitropin alfa administered with hCG on spermatogenesis in adult male hypogonadotropic hypogonadism (HH) patients.DesignPhase III, multicenter, open-label, noncomparative.SettingSeven US medical centers.Patient(s)A total of 36 adult males with severe HH.Intervention(s)A total of 1,000 U hCG on alternate days for 3 to 6 months, with dose adjustments after 2 months, if necessary, to normalize T levels, followed by follitropin alfa 150 U and hCG on the same alternate days for 18 months, with dose adjustments as necessary.Main Outcome Measure(s)Proportion of patients with sperm density ≥1.5 × 106/mL. Pubertal advancement and long-term safety and tolerability were also evaluated.Result(s)In total, 22 of 29 patients (75.9%) who received ≥1 dose of follitropin alfa and 20 of 25 patients (80%) who completed 18 months of hCG + follitropin alfa treatments achieved a sperm concentration ≥1.5 × 106/mL. A sperm concentration >20 × 106/mL was achieved by 8 of 29 men (27.5%). Median sperm concentration at 18 months was 5.2 × 106/mL. Pubertal development continued during the study, and testis volumes increased. Five clinical pregnancies were achieved. Acne (52% of patients) was the most common side effect, and gynecomastia was reported in 10% of patients.Conclusion(s)Long-term treatment of azoospermic HH men using follitropin alfa and hCG is effective for stimulating spermatogenesis and is well-tolerated.
Journal: Fertility and Sterility - Volume 92, Issue 3, September 2009, Pages 979–990