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)

This is an interventional treatment trial for Male Idiopathic Infertility Read More

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.
• 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.
• 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.

Exclusion Criteria:

• Previous FSH treatment 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.