Effectiveness of ClOmifeNe CitRate for the management of mEn wiTh infErtility (CONCRETE): A randomised double-blind placebo-controlled trial.
Male infertility
Patients will be randomised using the Sealed envelope platform on the computer to receive either 25mg Clomifene Citrate or a matching placebo, to be taken orally once a day for 9 months. • Experimental Arm: 25mg Clomifene Citrate • Control Arm: Placebo
1. Men assigned as biological male at birth 2. Aged ≥18-<45 years inclusive at baseline and randomisation. 3. Diagnosis of primary or secondary infertility at the time of screening, having been trying to conceive for ≥12 months with abnormal semen parameters due to: (i) reduced sperm concentration of ≤16 million spermatozoa per ml on as per the WHO criteria, or (ii) secondary functional hypogonadism (defined as early rise total testosterone ≤12pmol/l) after excluding other causes 4. Capacity to give informed consent
1. Primary testicular failure (confirmed with an FSH level of ≥15 IU/L) at time of screening 2. History of primary or secondary hypogonadotropic hypogonadism due to other congenital or acquired condition disturbing the hypothalamic-pituitary gonadal axis. 3. History of taking prescribed or non-prescribed hormonal treatment therapy including but not limited to clomifene, gonadotrophins, anabolic steroids and exogenous testosterone. 4. Other causes of male infertility including but not limited to; known obstructive azoospermia, untreated clinical varicocele, history of mumps orchitis, history of chemotherapy/radiotherapy treatment. 5. Abnormal karyotype, evidence of Y chromosome AZF microdeletion, cystic fibrosis gene abnormality, history of cryptorchidism