Effect of Denosumab on Sperm Concentration in Men With Severe Oligospermia: A Randomized Controlled Trial
Authors' conclusion
This RCT showed that denosumab did not improve sperm concentration or alter reproductive hormones compared to placebo. Denosumab is not superior to the vitamin D- and calcium-supplemented men in the placebo group.
Study context
- Population
- Men with severe oligospermia prospectively selected by serum anti-Müllerian hormone (AMH) and testicular size39 completed
- Participants
- 42 men
- Comparison
- Single SC injection of denosumab 60 mg vs placebo
- Denosumabn = 28
- Placebon = 14reference
- Primary endpoint
- Improvement in sperm concentration
- Follow-up
- Day 80
Methodological detailsdouble-blinded, placebo-controlled, single-center, randomized 2:1
- Double-blinded
- Placebo-controlled
- Single-center
- Randomized 2:1
Primary result
As reported in the abstract
Sperm concentration and total sperm count
- No differences in sperm concentration or total sperm count between denosumab and placebo
Further findings
Serum testosterone, LH, FSH, inhibin B, AMH
- No differences in serum testosterone, LH, FSH, inhibin B or AMH
Change from baseline · baseline to day 80
- Increase in sperm concentration and total sperm count, but not serum inhibin B, with both denosumab and placebo
Original publication
Effect of Denosumab on Sperm Concentration in Men With Severe Oligospermia: A Randomized Controlled Trial. J Clin Endocrinol Metab. Published 27 August 2025. doi:10. 1210/ clinem/ dgaf481
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