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The effect of body mass index on clomiphene citrate therapy outcomes for hypogonadal men
Alexander Plochocki, MD, MPH1, Alexander Erbella, MD2, Erin Burns, RN3, Susan Parks, CMA3, Nicole Rossetti, RN3, Matthew Wosnitzer, MD3.
1University of Vermont Medical Center, Burlington, VT, 2Florida State University College of Medicine / Tallahassee Memorial Healthcare, Tallahassee, FL, 3Yale New Haven Health, Northeast Medical Group, Fairfield, CT.

BACKGROUND: Standard exogenous testosterone replacement therapy may lead to fertility decline or azoospermia, as they suppress the natural hypothalamus-pituitary-gonadal (HPG) axis necessary for endogenous testosterone production and spermatogenesis. For men with future fertility interest or male factor infertility, clomiphene citrate (CC) provides a fertility-sparing treatment option, by increasing endogenous testosterone production.
METHODS: In a single male infertility clinic, our study retrospectively compared 100 consecutive men who were diagnosed with hypogonadism and treated by a single urologist with clomiphene citrate (CC) starting at 25mg every other day and titrated to eugonadal total testosterone (TT) up to a maximal dose of 50mg daily. Increase in TT from baseline after three months of treatment measured treatment effectiveness. Additional outcomes were measured with change in prostate specific antigen (PSA), estradiol, and hematocrit (HCT) from baseline after three months of treatment.
RESULTS: All BMI groups experienced an increase in TT (Figure 1), but patients with a normal BMI exhibited a greater increase in TT (p < 0.01). There was a minimal and non-significant change in PSA (p=0.37), estradiol (p=0.59), and HCT (p=0.13). Results are summarized in Table 1.
CONCLUSIONS: CC increases TT less in overweight, obese, and morbidly obese men, while exhibiting minimal change in PSA, estradiol, or HCT in all BMI groups. Our study's findings suggest that CC may be a more effective treatment for hypogonadism in normal-weighted men compared to overweight and obese men.

Table 1. BMI-Stratified demographics and results of hypogonadal men on clomiphene citrate
ParameterNormalOverweightObeseMorbidly Obesep value
Age (years)*3652974410423-
BMI (kg/m)*241271343486-
Δ Total Testosterone (ng/dL) 307 [221, 392]149 [100, 197]142 [100, 183]96 [2, 191]<0.005
Δ Estradiol (pg/mL) 6.2 [-1.9, 14]5.6 [0.90, 10.0]9.5 [5.58, 13.4]8.2 [-1.2, 17.6]0.59
Δ PSA (ng/mL) 0.23 [0.01, 0.45]0.04 [-0.06, 0.14]0.12 [0.03, 0.12]0.09 [-0.11, 0.29]0.37
Δ Hematocrit (%)1.2 [-0.3, 2.6]-0.1 [-0.8, 0.6]-0.1 [0.7, 0.5]1.4 [-0.1, 2.9]0.13

Notes: * means standard deviation; means and 95% confidence interval; N=100

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