Inclusion Criteria:

• * History of infertility for 12-60 months with current partner at randomization.
• * Men between the ages of 18 and 50 years.
• * Total sperm count 5-39 million at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomization.
• * Total motile sperm count of 5-16 million at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomization.
• * Semen volume ≥1.4 mL at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomization.
• * Serum follicle-stimulating hormone (FSH) levels of 1.5-8.0 IU/L (measured at central laboratory) at screening. (Approved in US: FSH levels of 2-12.0 IU/L (measured at central laboratory) at screening)
• * Serum luteinising hormone (LH) levels of 1.2-7.5 IU/L (measured at central laboratory) at screening.
• * Serum total testosterone levels of ≥300 ng/dL (equals ≥10.4 nmol/L; measured at central laboratory) at screening.
• * Agree to have regular intercourse with current female partner with the intent of spontaneous conception within 9 months from randomization.
• * Agree to provide information on female partner's positive urine pregnancy test(s) and documentation of ultrasound(s), delivery, and neonatal/infant health.
• Current partner fulfilling the criteria below:
• * Pre-menopausal woman between the ages of 18 and 35 years. (Approved in US: Pre-menopausal woman between the ages of 18 and 38 years.)
• * Regular menstrual cycles of 21-35 days.
• * No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation.
• * Agree not to obtain infertility treatment outside of this trial for 9 months from randomization of male subject. (Approved in US: However, after 6 months from randomisation, the subject's semen can be used in infertility treatment procedures of his partner.)

Exclusion Criteria:

• * Previous FSH treatment not leading to conception. (Approved in US: Previous FSH treatment for ≥4 months not leading to conception.)
• * Past or current use of finasteride within 3 months prior to screening.
• * Any history of anatomical disorder of the pituitary gland or testes.
• * Any structural abnormalities of the vas deferens (unilateral or bilateral) at screening.
• * Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact fertility.
• * Known history or presence of clinical varicocele (subclinical and Grade 1 varicocele are acceptable).
• * Known history of cryptorchidism, testicular torsion, or orchitis.
• * Known abnormal karyotype (including Y-chromosome microdeletion).
• * Current or past treatment of urogenital (kidney, bladder, testicular, or prostate) cancer as well as history of chemo- or radiotherapy that can have impact on testes.
• * Any known uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders).
• * Administration of hormonal preparations, agents known to impair testicular function or affect sex hormone secretion, and known or suspected teratogens within 3 months prior to screening. Administration of anabolic steroids within 12 months prior to screening.