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

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
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引用次数: 0

Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

Clinical Trials: NCT06300229. Registered on March 12, 2024. Clinical Trials Information System (CTIS): 2023-508325-27-00. Approved on December 19, 2023.

治疗少精症的新方法(NAPO)--随机对照试验方案
背景全球有数百万对夫妇患有不育症,其中高达 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殊医疗干预措施,无论不育的原因是什么,授精或体外受精都被频繁使用。地诺单抗是一种阻断 RANKL 信号传导的抗体,可提高不育男性的精液质量。这项随机对照试验将评估地诺单抗是否能改善以血清AMH水平为预测指标的精液质量严重受损男性的生精功能。方法NAPO是一项由赞助商-调查员发起的单中心、安慰剂对照、双盲随机试验。受试者将按 2:1 的比例随机接受皮下注射 60 毫克地诺单抗或安慰剂。研究将在丹麦赫勒夫的哥本哈根大学医院转化内分泌科进行。研究的主要结果是纳入研究后一次精子生成(80 天)时精子浓度(百万/毫升)的差异。通过这项研究,我们描述了一项计划中的 RCT 方案,该方案旨在评估使用地诺单抗治疗是否能改善精液质量严重受损的男性的精子浓度。这项研究的结果将为这一患者群体未来的治疗提供至关重要的证据:NCT06300229。注册日期:2024 年 3 月 12 日。临床试验信息系统(CTIS):2023-508325-27-00。批准日期:2023 年 12 月 19 日。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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