T-NOA - Novel Treatment of some men with Non-Obstructive AzoospermiaA clinical interventional trial

Phase 1

• Conditions: Male infertility; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

• Registration Number: CTIS2024-512996-11-00
• Lead Sponsor: Region Hovedstaden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Infertile men > 18 years and < 60 years with azoospermia with normal semen volume verified with a minimum of 2 semen samples, Testicle size (Prader orchidometer) = 15 ml on both sides, No identified causes of obstruction, Serum AMH = 28 pmol/

Exclusion Criteria

Men with chronic diseases (diabetes mellitus, thyroid disease, endocrine diseases requirering treatment such as sarcoidosis, tuberculosis, wegeners, vasculitis as well as inflammatory bowel diseases e.g. chron's disease or ulcerative colitis etc)., Poor dental status og dental implants, Latex allergy, Serum Inhibin B < 15 pg/mL, Androgen replacement therapy, Hypogonadotropic hypogonadism, BMI = 35 kg/m2, Chromosome abnormalities eg. Klinefelter Syndrome, XX male, AZFa/b/c microdeletions except b2/b3 og gr/gr, Verified/identified CFTR mutation, Men with active or previous malignant disease, Men in treatment for osteoporosis, Total calcium < 2.14 mmol/L or Albumin corrected calcium <2.17 mmol/L, Serum 25OHD < 25 nmol/L, eGFR <60 mL/min/1.73m^2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified