NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia
NCT ID: NCT06706414
Last Updated: 2025-12-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
16 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-03-01
Study Completion Date
2026-08-31
Brief Summary
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This clinical interventional study aims to assess whether treatment with denosumab in combination with letrozole can improve sperm production in infertile men with non-obstructive azoospermia selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker.
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Detailed Description
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Infertility is a health issue worldwide with more than 15% of couples experiencing infertility. Male factors contribute in 50% of all cases and is the sole cause in 30% of all infertile couples . Treatment options for the male infertility are limited and only specific conditions like varicocele and hypogonadotropic hypogonadism can be effectively treated with surgery and hormonal stimulation, respectively. However, for the remaining 90% of infertile men, no treatment options exist. Instead, their female partners must undergo fertility treatment.
Men with the most pronounced impairment of semen quality, men with azoospermia, have no sperm in the ejaculate and are classically divided into obstructive azoospermia (OA) and non-obstructive azoospermia (NOA), with the ladder being the most common. These men needs to have surgery performed for sperm retrieval with either testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or micro testicular sperm extraction (microTESE) in order to have a chance of becoming biological fathers. The chance of successful sperm retrieval in men with OA is close to 100%, whereas men with NOA have a significantly lower chance with only around 10-40% being successful. This is due to the vast difference in etiology between men with OA and NOA. Even with a successful surgical intervention only half of the cases will result in a live birth, leaving the majority of men with NOA no chance of becoming biological fathers. Therefore, novel treatment options for even a minor sub-group of these men are warranted.
RANKL is a ligand for the receptor activator of nuclear factor kappa beta (RANK), and their pathway plays a prominent role in the regulation of bone metabolism. The binding of RANKL to RANK on osteoclast precursors induces osteoclast maturation and activation, thereby stimulating bone resorption, and regulates cell cycle i.e., proliferation, differentiation, and apoptosis. Osteoprotegerin (OPG) is a secreted decoy receptor that controls RANKL-RANK interaction by binding RANKL and inhibits activation of RANK and preventing osteoclast differentiation and activation.
Denosumab, a drug used in millions of patients worldwide under trade names Prolia® and Xgeva®, inhibits the RANKL pathway and is used to treat osteoporosis and bone metastases. The drug's mechanism of action inhibits RANKL and thus inhibits bone resorption through reduced osteoclast activation. This reduces the loss of bone mineral density (BMD), which reduces the risk of bone loss and thereby the risk of fracture and osteoporosis. Denosumab has been shown in several clinical studies to be a safe and effective drug in both women and men and has been in clinical use in both sexes for many years. As Denosumab has a teratogenic effect, pharmacokinetic studies in both monkeys and healthy men were performed before approval of the drug as a treatment for osteoporosis in men. These studies showed that Denosumab concentration in semen does not pose a risk to the fetus during sexual intercourse with the pregnant woman and therefore is safe to use for the suggested infertility indication as there is no risk of fetal transmission.
The investigators have also shown that RANKL also influences germ cell apoptosis, differentiation, and proliferation in mice and humans. This indicates that the RANKL system could be a potential direct regulator of spermatogenesis, and thus highlighting that the drug Denosumab, a RANKL inhibitor, commonly used to treat osteoporosis, may be used for medical treatment of men with decreased sperm production. The effects of denosumab in vitro were supported by a pilot intervention study in 12 infertile men, which showed that denosumab either had a highly beneficial or detrimental effect on sperm production. This implies that only a sub-group of infertile men should be offered this treatment and these men should be identified by, preferably, a simple and accessible biomarker.
Therefore, the investigators are currently conducting two randomized clinical trials "First In Treating Infertility (FITMI)" and "Novel Approach for Oligospermia (NAPO) to explore whether denosumab can improve semen quality in infertile men selected by serum AMH, but already have sperm concentration between 2 mio/mL - 20 mio/mL (FITMI) and 0.01 mio/mL - 2 mio/mL (NAPO). These are both important studies, but still leaves out men with no sperm in the ejaculate, azoospermic patients. Therefore, there is a need for a trial adressing these patients for a potential novel treatment option.
NT-NOA is a single-center, sponsor-investigator-initiated, interventional trial, Following successful completion of screening procedures, subjects will all receive denosumab 60 mg s.c. and Letrozole oral tablet 2.5 mg once daily. Participants will all initiate letrozole treatment 14 days prior to the denosumab injection and will continue until the TESE procedure. The study will be carried out at the Division of Translational Endocrinology, Copenhagen University Hospital, Herlev, Copenhagen, Denmark.
The investigators believe it is of clinical relevance to treat 10 patients with denosumab in combination with letrozole for 1 of them to achieve sperm production, however, it is difficult to estimate. Ideally 50% of the treated participants will have sperm suitable for ART post intervention. By including 16 patients, there will be sufficient power to determine if combination therapy with denosumab and letrozole induces a clinically relevant effect on spermatogenesis.
Men with the most pronounced impairment of semen quality, men with azoospermia, have no sperm in the ejaculate and are classically divided into obstructive azoospermia (OA) and non-obstructive azoospermia (NOA), with the ladder being the most common. These men needs to have surgery performed for sperm retrieval with either testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or micro testicular sperm extraction (microTESE) in order to have a chance of becoming biological fathers. The chance of successful sperm retrieval in men with OA is close to 100%, whereas men with NOA have a significantly lower chance with only around 10-40% being successful. This is due to the vast difference in etiology between men with OA and NOA. Even with a successful surgical intervention only half of the cases will result in a live birth, leaving the majority of men with NOA no chance of becoming biological fathers. Therefore, novel treatment options for even a minor sub-group of these men are warranted.
RANKL is a ligand for the receptor activator of nuclear factor kappa beta (RANK), and their pathway plays a prominent role in the regulation of bone metabolism. The binding of RANKL to RANK on osteoclast precursors induces osteoclast maturation and activation, thereby stimulating bone resorption, and regulates cell cycle i.e., proliferation, differentiation, and apoptosis. Osteoprotegerin (OPG) is a secreted decoy receptor that controls RANKL-RANK interaction by binding RANKL and inhibits activation of RANK and preventing osteoclast differentiation and activation.
Denosumab, a drug used in millions of patients worldwide under trade names Prolia® and Xgeva®, inhibits the RANKL pathway and is used to treat osteoporosis and bone metastases. The drug's mechanism of action inhibits RANKL and thus inhibits bone resorption through reduced osteoclast activation. This reduces the loss of bone mineral density (BMD), which reduces the risk of bone loss and thereby the risk of fracture and osteoporosis. Denosumab has been shown in several clinical studies to be a safe and effective drug in both women and men and has been in clinical use in both sexes for many years. As Denosumab has a teratogenic effect, pharmacokinetic studies in both monkeys and healthy men were performed before approval of the drug as a treatment for osteoporosis in men. These studies showed that Denosumab concentration in semen does not pose a risk to the fetus during sexual intercourse with the pregnant woman and therefore is safe to use for the suggested infertility indication as there is no risk of fetal transmission.
The investigators have also shown that RANKL also influences germ cell apoptosis, differentiation, and proliferation in mice and humans. This indicates that the RANKL system could be a potential direct regulator of spermatogenesis, and thus highlighting that the drug Denosumab, a RANKL inhibitor, commonly used to treat osteoporosis, may be used for medical treatment of men with decreased sperm production. The effects of denosumab in vitro were supported by a pilot intervention study in 12 infertile men, which showed that denosumab either had a highly beneficial or detrimental effect on sperm production. This implies that only a sub-group of infertile men should be offered this treatment and these men should be identified by, preferably, a simple and accessible biomarker.
Therefore, the investigators are currently conducting two randomized clinical trials "First In Treating Infertility (FITMI)" and "Novel Approach for Oligospermia (NAPO) to explore whether denosumab can improve semen quality in infertile men selected by serum AMH, but already have sperm concentration between 2 mio/mL - 20 mio/mL (FITMI) and 0.01 mio/mL - 2 mio/mL (NAPO). These are both important studies, but still leaves out men with no sperm in the ejaculate, azoospermic patients. Therefore, there is a need for a trial adressing these patients for a potential novel treatment option.
NT-NOA is a single-center, sponsor-investigator-initiated, interventional trial, Following successful completion of screening procedures, subjects will all receive denosumab 60 mg s.c. and Letrozole oral tablet 2.5 mg once daily. Participants will all initiate letrozole treatment 14 days prior to the denosumab injection and will continue until the TESE procedure. The study will be carried out at the Division of Translational Endocrinology, Copenhagen University Hospital, Herlev, Copenhagen, Denmark.
The investigators believe it is of clinical relevance to treat 10 patients with denosumab in combination with letrozole for 1 of them to achieve sperm production, however, it is difficult to estimate. Ideally 50% of the treated participants will have sperm suitable for ART post intervention. By including 16 patients, there will be sufficient power to determine if combination therapy with denosumab and letrozole induces a clinically relevant effect on spermatogenesis.
Conditions
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Infertility, Male
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Denosumab
Subcutaneous injection with 60 mg Denosumab once
Group Type
EXPERIMENTAL
Denosumab (Prolia)
Intervention Type
DRUG
Subcutaneous injection with 60 mg Denosumab once
Letrozole (Aromatase Inhibitors)
Intervention Type
DRUG
Letrozole oral tablet 2.5 mg once daily
Interventions
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Denosumab (Prolia)
Subcutaneous injection with 60 mg Denosumab once
Intervention Type
DRUG
Letrozole (Aromatase Inhibitors)
Letrozole oral tablet 2.5 mg once daily
Intervention Type
DRUG
Eligibility Criteria
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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.
* No identifiable cause of obstruction.
* Testis size (Prader Orchidometer) ≤ 15 mL on both sides in patients where no prior TESE is available
* Serum AMH levels ≥5 pmol/L.
* No identifiable cause of obstruction.
* Testis size (Prader Orchidometer) ≤ 15 mL on both sides in patients where no prior TESE is available
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
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Martin Blomberg Jensen
OTHER
Sponsor Role
lead
Responsible Party
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Martin Blomberg Jensen
Head of Research Department Endocrinology
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Christian F.S. Jensen, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Herlev and Gentofte Hospital
Locations
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Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Herlev and Gentofte Hospital
Herlev, , Denmark
Site Status
Countries
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Denmark
References
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Anastasilakis AD, Toulis KA, Polyzos SA, Terpos E. RANKL inhibition for the management of patients with benign metabolic bone disorders. Expert Opin Investig Drugs. 2009 Aug;18(8):1085-102. doi: 10.1517/13543780903048929.
Reference Type
BACKGROUND
Huynh AL, Baker ST, Stewardson AJ, Johnson DF. Denosumab-associated hypocalcaemia: incidence, severity and patient characteristics in a tertiary hospital setting. Pharmacoepidemiol Drug Saf. 2016 Nov;25(11):1274-1278. doi: 10.1002/pds.4045. Epub 2016 Jun 3.
Reference Type
BACKGROUND
Skakkebaek NE, Rajpert-De Meyts E, Main KM. Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects. Hum Reprod. 2001 May;16(5):972-8. doi: 10.1093/humrep/16.5.972.
Reference Type
BACKGROUND
Toulis KA, Anastasilakis AD. Increased risk of serious infections in women with osteopenia or osteoporosis treated with denosumab. Osteoporos Int. 2010 Nov;21(11):1963-4. doi: 10.1007/s00198-009-1145-1. Epub 2009 Dec 15. No abstract available.
Reference Type
BACKGROUND
Anastasilakis AD, Toulis KA, Goulis DG, Polyzos SA, Delaroudis S, Giomisi A, Terpos E. Efficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysis. Horm Metab Res. 2009 Oct;41(10):721-9. doi: 10.1055/s-0029-1224109. Epub 2009 Jun 17.
Reference Type
BACKGROUND
Bone HG, Chapurlat R, Brandi ML, Brown JP, Czerwinski E, Krieg MA, Mellstrom D, Radominski SC, Reginster JY, Resch H, Ivorra JA, Roux C, Vittinghoff E, Daizadeh NS, Wang A, Bradley MN, Franchimont N, Geller ML, Wagman RB, Cummings SR, Papapoulos S. The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension. J Clin Endocrinol Metab. 2013 Nov;98(11):4483-92. doi: 10.1210/jc.2013-1597. Epub 2013 Aug 26.
Reference Type
BACKGROUND
Lamy O, Stoll D, Aubry-Rozier B, Rodriguez EG. Stopping Denosumab. Curr Osteoporos Rep. 2019 Feb;17(1):8-15. doi: 10.1007/s11914-019-00502-4.
Reference Type
BACKGROUND
Uebelhart B, Rizzoli R, Ferrari SL. Retrospective evaluation of serum CTX levels after denosumab discontinuation in patients with or without prior exposure to bisphosphonates. Osteoporos Int. 2017 Sep;28(9):2701-2705. doi: 10.1007/s00198-017-4080-6. Epub 2017 May 24.
Reference Type
BACKGROUND
Bekker PJ, Holloway DL, Rasmussen AS, Murphy R, Martin SW, Leese PT, Holmes GB, Dunstan CR, DePaoli AM. A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Miner Res. 2004 Jul;19(7):1059-66. doi: 10.1359/JBMR.040305. Epub 2004 Mar 1.
Reference Type
BACKGROUND
Blomberg Jensen M, Andreassen CH, Jorgensen A, Nielsen JE, Juel Mortensen L, Boisen IM, Schwarz P, Toppari J, Baron R, Lanske B, Juul A. RANKL regulates male reproductive function. Nat Commun. 2021 Apr 23;12(1):2450. doi: 10.1038/s41467-021-22734-8.
Reference Type
BACKGROUND
Bussiere JL, Pyrah I, Boyce R, Branstetter D, Loomis M, Andrews-Cleavenger D, Farman C, Elliott G, Chellman G. Reproductive toxicity of denosumab in cynomolgus monkeys. Reprod Toxicol. 2013 Dec;42:27-40. doi: 10.1016/j.reprotox.2013.07.018. Epub 2013 Jul 22.
Reference Type
BACKGROUND
Sohn W, Lee E, Kankam MK, Egbuna O, Moffat G, Bussiere J, Padhi D, Ng E, Kumar S, Slatter JG. An open-label study in healthy men to evaluate the risk of seminal fluid transmission of denosumab to pregnant partners. Br J Clin Pharmacol. 2016 Feb;81(2):362-9. doi: 10.1111/bcp.12798. Epub 2015 Dec 5.
Reference Type
BACKGROUND
Boonen S, Adachi JD, Man Z, Cummings SR, Lippuner K, Torring O, Gallagher JC, Farrerons J, Wang A, Franchimont N, San Martin J, Grauer A, McClung M. Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk. J Clin Endocrinol Metab. 2011 Jun;96(6):1727-36. doi: 10.1210/jc.2010-2784. Epub 2011 Mar 16.
Reference Type
BACKGROUND
Papapoulos S, Chapurlat R, Libanati C, Brandi ML, Brown JP, Czerwinski E, Krieg MA, Man Z, Mellstrom D, Radominski SC, Reginster JY, Resch H, Roman Ivorra JA, Roux C, Vittinghoff E, Austin M, Daizadeh N, Bradley MN, Grauer A, Cummings SR, Bone HG. Five years of denosumab exposure in women with postmenopausal osteoporosis: results from the first two years of the FREEDOM extension. J Bone Miner Res. 2012 Mar;27(3):694-701. doi: 10.1002/jbmr.1479.
Reference Type
BACKGROUND
Polyzos SA, Singhellakis PN, Naot D, Adamidou F, Malandrinou FC, Anastasilakis AD, Polymerou V, Kita M. Denosumab treatment for juvenile Paget's disease: results from two adult patients with osteoprotegerin deficiency ("Balkan" mutation in the TNFRSF11B gene). J Clin Endocrinol Metab. 2014 Mar;99(3):703-7. doi: 10.1210/jc.2013-3762. Epub 2014 Jan 16.
Reference Type
BACKGROUND
Schwarz P, Rasmussen AQ, Kvist TM, Andersen UB, Jorgensen NR. Paget's disease of the bone after treatment with Denosumab: a case report. Bone. 2012 May;50(5):1023-5. doi: 10.1016/j.bone.2012.01.020.
Reference Type
BACKGROUND
Makras P, Polyzos SA, Papatheodorou A, Kokkoris P, Chatzifotiadis D, Anastasilakis AD. Parathyroid hormone changes following denosumab treatment in postmenopausal osteoporosis. Clin Endocrinol (Oxf). 2013 Oct;79(4):499-503. doi: 10.1111/cen.12188. Epub 2013 Apr 1.
Reference Type
BACKGROUND
Anastasilakis AD, Toulis KA, Polyzos SA, Anastasilakis CD, Makras P. Long-term treatment of osteoporosis: safety and efficacy appraisal of denosumab. Ther Clin Risk Manag. 2012;8:295-306. doi: 10.2147/TCRM.S24239. Epub 2012 Jun 19.
Reference Type
BACKGROUND
Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756-65. doi: 10.1056/NEJMoa0809493. Epub 2009 Aug 11.
Reference Type
BACKGROUND
Kwiecinski GG, Petrie GI, DeLuca HF. Vitamin D is necessary for reproductive functions of the male rat. J Nutr. 1989 May;119(5):741-4. doi: 10.1093/jn/119.5.741.
Reference Type
BACKGROUND
Uhland AM, Kwiecinski GG, DeLuca HF. Normalization of serum calcium restores fertility in vitamin D-deficient male rats. J Nutr. 1992 Jun;122(6):1338-44. doi: 10.1093/jn/122.6.1338.
Reference Type
BACKGROUND
Blomberg Jensen M. Vitamin D and male reproduction. Nat Rev Endocrinol. 2014 Mar;10(3):175-86. doi: 10.1038/nrendo.2013.262. Epub 2014 Jan 14.
Reference Type
BACKGROUND
Other Identifiers
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2024-512996-11-00
Identifier Type: CTIS
Identifier Source: secondary_id
2024-512996-11-00
Identifier Type: -
Identifier Source: org_study_id
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