Abstract
Abstract Introduction Clomiphene citrate (CC), a selective estrogen receptor modulator, and anastrozole, a selective aromatase inhibitor, are common empiric medical therapies for men with idiopathic infertility. The effects of jointly administering these agents are not well understood. Objective The objective of this study is to compare semen parameters in men treated with clomiphene citrate and anastrozole (CC-A) combination therapy to those in men taking anastrozole alone. Methods We performed a multi-center, retrospective cohort study of men with idiopathic infertility prescribed anastrozole at two tertiary referral institutions. Demographic, laboratory, and prescription data were captured. The subset of patients taking CC at the time of anastrozole initiation were identified. Patients with pre-treatment normozoospermia, recent or current exogenous testosterone or human chorionic gonadotropin use, previous orchiectomy, and scrotal surgery during the treatment period were excluded. Outcome measures included changes in World Health Organization sperm concentration category (WHO-SCC) following initiation of anastrozole therapy. Linear and logistic regression models were constructed to evaluate the association of combination therapy with these outcomes. Results 72 men were included in the analysis cohort, including 54 men taking anastrozole alone and 18 men on CC therapy who subsequently started taking anastrozole (CC-A). Men on CC-A relative to anastrozole monotherapy were older (40 vs. 35 years, p=0.03) and had a lower BMI (30 vs. 34 kg/m^2, p=0.05), respectively. Pre-treatment LH levels (5.6 vs. 7.6 IU/L, p=0.25) and testosterone (336 vs 263 ng/dL, p=0.32) were similar. Baseline semen parameters including sperm concentration (3.7 vs. 2.3 M/mL, p=0.26) and motility (41 vs. 36%, p= 0.17) were also comparable. However, post-treatment median sperm concentration (6.9 vs. 3.4M/mL, p=0.02) and the change in mean sperm concentration (17.5 vs. 6.2 M/mL, p=0.03) were significantly higher in the CC-A combination group. Univariate linear regression also revealed an association between the use of CCA combination therapy and increase in sperm concentration (p=0.05). Despite these differences, WHO-SCC upgrade rates between groups were comparable (56 vs. 39%, p=0.22) in the setting of similar post-treatment levels of LH (7.4 vs. 8.6 IU/L, p=0.5), FSH (8.6 vs. 9.4 IU/mL, p=0.19), and testosterone (537 vs. 415 ng/dL, p=0.09). Conclusions Combination therapy with clomiphene citrate and anastrozole was associated with modest benefits in post-treatment sperm concentration when compared to anastrozole monotherapy. Combination empiric medical therapy using clomiphene citrate and anastrozole offers a small, but significant, clinical benefit over anastrozole alone for infertile men Disclosure No
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