A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)

Inclusion Criteria:

• History of infertility with current partner at randomisation must be 12-60 months ifcurrent partner is aged <35 years or 6-60 months if current partner is aged 35-38years.

• Men between the ages of 18 and 50 years.

• Total sperm count 5-39 million at screening; confirmed by two consecutive samplestaken ≥2 weeks apart before randomization.

• Total sperm motility of ≥10% at screening; confirmed by two samples taken ≥2 weeksapart before randomisation. If a semen sample has been taken within 3 months priorto screening and been analysed at an andrology laboratory, it can be included as thefirst of the two semen samples at screening.

• Semen volume ≥1.4 mL at screening; confirmed by two consecutive samples taken ≥2weeks apart before randomization.

• Serum follicle-stimulating hormone (FSH) levels of 2-12.0 IU/L (measured at centrallaboratory) at screening)

• Serum luteinising hormone (LH) levels of 1.2-7.5 IU/L (measured at centrallaboratory) at screening.

• Serum total testosterone levels of ≥300 ng/dL (equals ≥10.4 nmol/L; measured atcentral laboratory) at screening.

• Agree to have regular intercourse with current female partner with the intent ofspontaneous 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 38 years (both inclusive) at thetime of randomisation of male participant.

• Regular menstrual cycles of 21-35 days.

• No history or current condition of pelvic inflammatory disease, endometriosis stageII-IV by definite or empirical diagnosis, or tubal ligation.

• Agree not to obtain infertility treatment outside of this trial for 6 months fromrandomization of male subject.

Exclusion Criteria:

• 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) atscreening.

• Any known, clinically significant, systemic disease in addition to the trialindication that might negatively impact fertility.

• Known history or presence of clinical varicocele (subclinical and Grade 1 varicoceleare 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, pituitarydisorders).

• Administration of hormonal preparations, agents known to impair testicular functionor affect sex hormone secretion, and known or suspected teratogens within 3 monthsprior to screening. Administration of anabolic steroids within 12 months prior toscreening.