NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia

Launched by MARTIN BLOMBERG JENSEN · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial, called NT-NOA, is investigating a new treatment to help some men who have trouble producing sperm, a condition known as non-obstructive azoospermia, which means there is no sperm in the semen due to non-blocked pathways. The researchers want to see if a combination of two medications, denosumab and letrozole, can improve sperm production in these men. To participate, men must be between 18 and 60 years old, have normal semen volume, and meet specific health criteria, such as having certain hormone levels and no identifiable causes of obstruction.

If eligible and enrolled in the trial, participants can expect to receive the study medication and be monitored closely for changes in sperm production. This trial is currently recruiting participants, and it’s important to note that men with certain health issues, like chronic diseases or specific genetic conditions, will not be able to join. Overall, this study aims to explore a potential new option for men facing infertility due to low sperm production.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Infertile men ≥ 18 years and \< 60 years of age with azoospermia with normal semen volume (\> 0.9 mL) verified by minimum 2 semen samples.
• • Testis size (Prader Orchidometer) ≤ 15 mL on both sides.
• • No identifiable cause of obstruction.
• • Serum AMH levels ≥5 pmol/L.
• Exclusion Criteria:
• • Chronic diseases, defined as diagnosis where signs, symptoms, and treatment imply an expected long duration and lack of a cure, such as diabetes mellitus, metabolism disorders, osteoporosis, colitis, etc.
• • Chromosome anomalies e.g. Klinefelter Syndrome, XX male
• • AZFa/b/c microdeletions besides b2/b3 og gr/gr
• • Detected CFTR mutation
• • Men with current or previous malignancies, or at potential risk of testicular cancer after baseline examination and ultrasound will be excluded
• • Men with hypocalcemia at baseline, defined as albumin corrected calcium \< 2.17 mmol/L or total calcium \< 2.14 mmol/L
• • Serum vitamin D (25OHD) levels \< 25 nmol/L
• • estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1,73 m2
• • Insufficient dental status
• • Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded.
• • Serum Inhibin B \< 5 pg/mL
• • Androgen replacement therapy
• • Hypogonadotropic hypogonadism
• • BMI ≥ 35 kg/m2