Novel approach for oligospermia (NAPO) - Protocol for a randomized controlled trial

Area of Science:

• Reproductive Endocrinology
• Male Infertility Research
• Clinical Trials

Background:

• Male infertility affects millions globally, often due to impaired semen quality.
• Current treatments for male infertility are limited, necessitating new therapeutic strategies.
• Denosumab, a RANKL inhibitor, shows potential for enhancing semen quality.

Purpose of the Study:

• To evaluate denosumab's efficacy in improving sperm concentration in men with severe male infertility.
• To assess the impact of denosumab on spermatogenesis using serum AMH levels as a predictive marker.
• To provide evidence for novel male infertility treatments.

Main Methods:

• A randomized controlled trial (RCT) involving denosumab versus placebo.
• Participants randomized in a 2:1 ratio to receive denosumab (60 mg subcutaneously) or placebo.
• Primary outcome: difference in sperm concentration after one spermatogenesis cycle (80 days).

Main Results:

• This section is for results, which are not yet available as the study is planned.
• The study aims to determine if denosumab significantly increases sperm concentration.
• Further analysis will focus on the impact on spermatogenesis.

Conclusions:

• This planned RCT will investigate a novel therapeutic approach for male infertility.
• Results are expected to inform future treatment strategies for men with severely impaired semen quality.
• The study addresses a critical unmet need for effective male infertility interventions.