Clomiphene in male infertility (CIMI) trial: A double-blind randomised placebo-controlled trial of clomiphene in normogonadotrophic idiopathic male infertility

INTERVENTION: Prospective double‐blind randomised control trial comparing clomiphene versus placebo in men with unexplained infertility and normal levels of serum gonadotrophins. Eligible men will be randomised to one of two study groups in a 1:1 ratio (clomiphene or placebo). Both groups will receive menevit, which is a commercially available men's fertility multivitamin. Intervention group ‐ Clomiphene 25 mg once daily, oral tablet, duration 6 months (180 days) ‐ Menevit 1 tablet daily, oral tablet, duration 6 months (180 days) Adherence will be assessed by research team by inspecting a medication diary kept by participants. CONDITION: Male infertility; ; Male infertility Reproductive Health and Childbirth ‐ Fertility including in vitro fertilisation PRIMARY OUTCOME: Total sperm count, measured on a standard semen analysis.[4 weeks after commencement of intervention; 12 weeks after commencement of intervention; 24 weeks after commencement of intervention (primary timepoint) ] SECONDARY OUTCOME: Live births, as reported by participants via telephone report[24 weeks after commencement of intervention ; 36 weeks after commencement of intervention] Normal sperm morphology, measured by standard semen analysis[4 weeks after commencement of intervention ; 12 weeks after commencement of intervention ; 24 weeks after commencement of intervention] Pregnancies, reported by participants via an online study‐specific survey[4 weeks after commencement of intervention ; 12 weeks after commencement of intervention ; 24 weeks after commencement of intervention ; 36 weeks after commencement of intervention] Progressive sperm motility, measured by standard semen analysis[4 weeks after commencement of intervention ; 12 weeks after commencement of intervention ; 24 weeks after commencement of intervention] Serum FSH, measured by blood test[4 weeks after commencement of intervention ; 12 weeks after commencement of intervention ; 24 weeks after commencement of intervention] Serum LH, measured on a blood test[4 weeks after commencement of intervention ; 12 weeks after commencement of intervention ; 24 weeks after commencement of intervention] Serum total testosterone, measured on a blood test[4 weeks after commencement of intervention ; 12 weeks after commencement of intervention ; 24 weeks after commencement of intervention] Sperm concentration, measured on standard semen analysis[4 weeks after commencement of intervention ; 12 weeks after commencement of intervention ; 24 weeks after commencement of intervention ] Total motile sperm count, measured by standard semen analysis[4 weeks after commencement of intervention ; 12 weeks after commencement of intervention ; 24 weeks after commencement of intervention ] INCLUSION CRITERIA: 1) Men of heterosexual couples with at least 12 months of infertility 2) Aged 18‐50 years at enrolment 3) Able to provide informed consent in English 4) Have at least two semen analysis in the preceding 6 months showing oligozoospermia (<10 million/ml or total count <26 million)