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Fertil Steril. 2009 Sep;92(3):979-90. doi: 10.1016/j.fertnstert.2008.07.1742. Epub 2008 Oct 18.

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

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1
Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA.

Abstract

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 > or =1.5 x 10(6)/mL. Pubertal advancement and long-term safety and tolerability were also evaluated.

RESULT(S):

In total, 22 of 29 patients (75.9%) who received > or =1 dose of follitropin alfa and 20 of 25 patients (80%) who completed 18 months of hCG + follitropin alfa treatments achieved a sperm concentration > or =1.5 x 10(6)/mL. A sperm concentration >20 x 10(6)/mL was achieved by 8 of 29 men (27.5%). Median sperm concentration at 18 months was 5.2 x 10(6)/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.

[Indexed for MEDLINE]

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