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NT-NOA - Novel Treatment of some men with Non-Obstructive Azoospermia A clinical interventional trial
EU CTIS ID: 2024-512996-11-00
What this study is testing
The aim of this intervention is to investigate whether Denosumab can improve semen quality in a subgroup of infertile men.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 ≥ 18 pmol/L
You likely can't join if
- 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).
- 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
See the full eligibility 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 ≥ 18 pmol/L
- 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).
- 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
- Prior thromboembolic event
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.