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Introduction: It is well established that exogenous testosterone replacement therapy (TRT) may be detrimental to a man’s fertility. However, clomiphene citrate (CC) is commonly used, off-label, to treat hypogonadal men in a fertility preserving manner. Polycythemia is a concerning side effect of direct TRT but there is no data regarding CC and polycythemia risk.
Methods: The incidence of polycythemia was retrospectively assessed in men diagnosed with hypogonadism and treated with CC at the University of Virginia and Austin Fertility & Reproductive Medicine between 3/2011 - 1/2015. The primary and secondary outcomes were development of polycythemia (defined as a hematocrit > 52%) after CC treatment and absolute changes in testosterone (T) and hematocrit (Hct), respectively.
Results: A total of 157 men were included, with a median age of 37 years (range 20-84 years; IQR 12.75 years), and mean duration of CC treatment of 6.6 months. There were three cases of polycythemia (mean Hct 52.9%, mean T 775.7 ng/dL), with an incidence of 1.9%. Following initiation of CC, the mean increase in T was 371.7 ng/dL (95% CI: 339.3 ng/dL, 404.1 ng/dL), and the mean increase in Hct was 0.57% (95% CI: 0.17%, 0.97%).
Conclusions: The incidence of polycythemia in this population of men treated with CC is markedly lower than reported rates for TRT treated men and is not associated with supra-therapeutic testosterone levels. The improvement in absolute T levels was similar to TRT treated men. There is not a significant risk of polycythemia in men treated with CC for hypogonadism.