Prospective Two-arm Study of Fertility in Men With COVID-19
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Semen quality analysis - motility
研究概览
简要总结
COVID-19 infection is hypothesized to have a potentially negative effect on male fertility through direct damage to the testes. The current trial is aimed at investigating the effect of SARS-CoV-2 on fertility and determining if viral bodies are capable of directly damaging testicular cells
详细描述
In late December 2019, the Chinese city of Wuhan witnessed the emergence of a form of pneumonia of unknown etiology. By the middle of January 2020, the disease had managed to spread beyond the country of origin and is now classified by the WHO as the largest pandemic in modern history.
Rapidly spreading and highly contagious, the infection prompted medical professionals all over the world to begin research into the virus with the goal of developing early diagnostic techniques and treatment strategies.
The new pathogen named SARS-Cov-2 belongs to the Coronaviridae family. These viruses cause severe acute respiratory syndrome (SARS-CoV-1, 2002-2003) and Middle East respiratory syndrome (MERS, 2012-2013).
The effects of SARS-CoV-2 on the human body stem from its structure. The spike proteins on the surface of the virus, which are responsible for the name "Coronaviridae," means that it is able to bind to the host receptor protein, angiotensin-converting enzyme 2 (ACE2). This makes cells with high quantities of these receptors on the surface susceptible to the virus.
The genome of SARS-Cov-2 responsible for the COVID-19 pandemic contains both human coronavirus fragments and bat coronavirus fragments (HKU9-1). It is the genetic material of HKU9-1 that makes SARS-CoV-2 unknown to the immune system of the human body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Clinical or imaging signs of COVID-19 infection
- •Nasopharyngeal swab positive for SARS-CoV2 mRNA
排除标准
- •Inability to collect semen for analysis
- •Congenital anomalies of the testes
- •Varicocele
- •A history of fertility disorders
结局指标
主要结局
Semen quality analysis - motility
时间窗: 3 months
motility of spermatozoa
Semen quality analysis - shape
时间窗: 3 months
shape of spermatozoa
Semen quantity analysis
时间窗: 3 months
count of spermatozoa
次要结局
- FSH(3 months)
- Damage of the testes on pathology(3 months)
- LH(3 months)
- Testosterone(3 months)
- Prolactin(3 months)
研究者
Dmitry Enikeev, MD, PhD
Deputy Director for Research
I.M. Sechenov First Moscow State Medical University