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)

• Status: Not yet recruiting
• Trial end date: 2024-12-24
• Target enrollment: 0
• Participant gender: Male

Summary

The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female partners in comparison to placebo (inactive treatment).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Follicle Stimulating Hormone

Criteria

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.