Introduction & Objective :
Clomiphene citrate (CC) is commonly used off-label for the treatment of male infertility. Response rates are variable and there is a paucity of data to guide patient selection. To aid in shared decision making with patients, this study aimed to define response rates among men receiving CC, specifically in regards to improvement in total motile count (TMC) in semen analysis.
Methods : A retrospective analysis was performed on a cohort of 151 men treated with at least 25 mg of CC daily for male infertility and/or hypogonadism at two institutions between 2004 and 2014. Inclusion criteria consisted of documented pretreatment hormone profiles and pre- and post-treatment semen analyses. Men previously on testosterone were excluded. The primary outcome was change in semen parameters. Based on values available in the literature, a patient with a TMC > 5 million was considered a candidate for intrauterine insemination (IUI), while a patient with a TMC > 20 million was considered a candidate for spontaneous pregnancy.
Results : A total of 77 men met criteria for analysis. Median duration of therapy was 2.8 months. There was a statistically significant increase in TMC from 13 million to 28 million (p = 0.04). Sixty-three men (82% of the cohort) had abnormal pretreatment TMC (< 20 million); 12 of these men (19%) became candidates for spontaneous pregnancy post-treatment. Forty-six men (60% of the cohort) were not IUI candidates pretreatment (TMC < 5); 16 of these men (35%) became candidates for IUI post-treatment.
Men receiving CC showed a statistically significant improvement in TMC post-treatment. Among men who were not initially candidates for IUI, over one third became candidates after less than three months of therapy. CC may help increase reproductive options for couples with male factory infertility, especially those considering IUI.