Stimulation of spermatogenesis with recombinant human follicle-stimulating hormone (follitropin alfa; GONAL-f®): long-term treatment in azoospermic men with hypogonadotropic hypogonadism  

Oleh:

Matsumoto, Alvin M. ; Snyder, Peter J. ; Bhasin, Shalender ; Martin, Kathryn ; Weber, Thomas

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Fertility and Sterility (keterangan: ada di ClinicalKey) vol. 92 no. 03 (Sep. 2009), page 979-990 .
Topik: Hypogonadotropic hypogonadism; gonadotropin deficiency; Kallmann's syndrome; follicle-stimulating hormone; chorionic gonadotropin; spermatogenesis; follitropin alfa

Ketersediaan

Perpustakaan FK Nomor Panggil: F02.K.2009.03 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Objective To demonstrate the efficacy and safety of follitropin alfa administered with hCG on spermatogenesis in adult male hypogonadotropic hypogonadism (HH) patients. Design Phase III, multicenter, open-label, noncomparative. Setting Seven 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.

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