Yahyavi Sam Kafai, Jorsal Mads Joon, Holt Rune, Nøhr Bugge, Blomberg Jensen Martin
Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital - Herlev and Gentofte, Herlev, Denmark.
Group of Skeletal, Mineral and Gonadal Endocrinology, Department of Growth and Reproduction, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Contemp Clin Trials Commun. 2024 Aug 22;41:101352. doi: 10.1016/j.conctc.2024.101352. eCollection 2024 Oct.
Infertility affects millions of couples globally, with up to 40-50 % of cases linked to impaired semen quality. Insemination or in vitro fertilization are used frequently, regardless of the cause of infertility due to the lack of specific medical interventions for male infertility. Denosumab, an antibody blocking RANKL signaling, may enhance semen quality in infertile men. This randomized controlled trial evaluates if denosumab improves spermatogenesis in men with severely impaired semen quality identified by serum AMH levels as a predictive marker.
NAPO is a single-center, sponsor-investigator-initiated, placebo-controlled, double-blinded randomized trial. Subjects will be randomized in a 2:1 fashion to receive either denosumab 60 mg subcutaneously or a placebo. The study will be carried out at the Division of Translational Endocrinology, Copenhagen University Hospital, Herlev, Denmark. The primary outcome of the study is defined as the difference in sperm concentration (millions/mL) at one spermatogenesis (80 days) after inclusion.
An important step in addressing infertility is establishing a viable treatment option for male infertility. With this study, we describe the protocol for a planned RCT aimed at evaluating whether treatment with denosumab can improve sperm concentration in men with severely impaired semen quality. The results of this study will provide evidence crucial for future treatment in a patient group where treatment options are minimal at best.
Clinical Trials: NCT06300229. Registered on March 12, 2024. Clinical Trials Information System (CTIS): 2023-508325-27-00. Approved on December 19, 2023.
不孕症影响着全球数百万对夫妇，高达40%-50%的病例与精液质量受损有关。由于缺乏针对男性不育症的特定医学干预措施，人工授精或体外受精被频繁使用。地诺单抗是一种阻断RANKL信号传导的抗体，可能会提高不育男性的精液质量。这项随机对照试验评估地诺单抗是否能改善以血清AMH水平作为预测标志物、精液质量严重受损的男性的精子发生。
NAPO是一项单中心、由申办者-研究者发起、安慰剂对照、双盲随机试验。受试者将以2:1的方式随机分组，分别接受皮下注射60mg地诺单抗或安慰剂。该研究将在丹麦赫勒夫哥本哈根大学医院转化内分泌科进行。该研究的主要结局定义为纳入后一个精子发生周期（80天）时精子浓度（百万/mL）的差异。
解决不孕症的一个重要步骤是为男性不育症建立可行的治疗方案。通过这项研究，我们描述了一项计划中的随机对照试验方案，旨在评估地诺单抗治疗是否能改善精液质量严重受损男性的精子浓度。这项研究的结果将为未来治疗选择极少的患者群体提供至关重要的证据。
临床试验：NCT06300229。于2024年3月12日注册。临床试验信息系统（CTIS）：2023-508325-27-00。于2023年12月19日获批。
