NCT05212337 is a Phase 2 clinical trial of Denosumab in Infertility, Male, sponsored by Martin Blomberg Jensen.

Who is sponsoring NCT05212337?

NCT05212337 is sponsored by Martin Blomberg Jensen.

What drugs are being tested in NCT05212337?

Interventions in NCT05212337: Denosumab, Sodium chloride.

What condition does NCT05212337 study?

NCT05212337 studies Infertility, Male.

Is NCT05212337 still recruiting?

NCT05212337 is currently active, enrolled. Last updated 15 November 2024.

Last reviewed 2024-11-15 · How we verify

NCT05212337

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FITMI - First In Treating Male Infertility

Active, enrolled Phase 2 Last updated 15 November 2024

What this trial tests

Phase 2 trial testing Denosumab in Infertility, Male in 180 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2022

Primary endpoint
22 October 2024

30 September 2025

Quick facts

Lead sponsor	Martin Blomberg Jensen
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	180
Start date	1 January 2022
Primary completion	22 October 2024
Estimated completion	30 September 2025
Sites	1 location across Denmark

Drugs / interventions tested

Denosumab (DENOSUMAB) — full drug profile →
Sodium chloride (Sodium Chloride) — full drug profile →

Conditions studied

Infertility, Male — all drugs for Infertility, Male →

Sponsor

Martin Blomberg Jensen — full company profile →

Who can join

Adults 18 to 60, male only, with Infertility, Male. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This RCT aims to assess whether treatment with Denosumab can improve semen quality in infertile men selected by serum AMH as a positive predictive biomarker.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Effect of a single-dose denosumab on semen quality in infertile men (the FITMI study): study protocol for a randomized controlled trial.
Yahyavi SK, Holt R, Juel Mortensen L, Petersen JH, et al · · 2022 · cited 7× · PMID 35733213 · DOI 10.1186/s13063-022-06478-4
Low-serum antimüllerian hormone is linked with poor semen quality in infertile men screened for participation in a randomized controlled trial.
Holt R, Yahyavi SK, Wall-Gremstrup G, Jorsal MJ, et al · · 2024 · cited 3× · PMID 38522503 · DOI 10.1016/j.fertnstert.2024.03.018
Effect of denosumab on semen quality in infertile men selected by serum level of antimüllerian hormone: a randomized controlled trial.
Yahyavi SK, Holt R, Jorsal MJ, Wall-Gremstrup G, et al · · 2025 · PMID 40403914 · DOI 10.1016/j.fertnstert.2025.05.151

Verify or expand the search:

Other trials of Denosumab

Trials testing the same drug.

NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
NCT07283887 — Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis · Phase 4 · recruiting
NCT06374459 — Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Br · Phase 1, PHASE2 · recruiting
NCT06749886 — An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1- · Phase 2 · recruiting
NCT06524960 — Denosumab for Type 1 Diabetes · Phase 1, PHASE2 · recruiting

Other recruiting trials for Infertility, Male

Currently open trials in the same condition.

NCT06950203 — The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality · NA · recruiting
NCT06539585 — Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality · NA · active not recruiting
NCT05514223 — Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors · recruiting
NCT06841861 — Spermatogonial Differentiation Via Testicular Organoid · Phase 1, PHASE2 · recruiting
NCT05903859 — Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI) · Phase 3 · recruiting

Other Martin Blomberg Jensen trials

Trials by the same sponsor.

NCT06300229 — NAPO - Novel Approach for Oligospermia · Phase 1, PHASE2 · completed
NCT04292288 — Hypercalcemia After Paraffin Oil Injection · recruiting
NCT03418896 — Extragonadal Effects of hCG on Calcium Homeostasis · Phase 1 · completed
NCT03254641 — Calciotropic Effects After HCG Stimulation Test · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05212337 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Martin Blomberg Jensen
Last refreshed: 15 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05212337.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing