跳至主要内容
临床试验/NCT04717011
NCT04717011Unknown不适用

Case Series Biomedical Study to Detect the Presence of SARS-CoV-2 in Semen of Patients Diagnosed With COVID-19 Disease

Igenomix1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
Igenomix
入组人数
100
试验地点
1
主要终点
SARS-CoV-2 semen result

研究概览

简要总结

A descriptive, clinical series, single-centre, national, biomedical study to determine the presence of SARS-CoV-2 in sperm samples from positive PCR patients for COVID-19 and to evaluate the presence of the virus in the sperm samples after a negative PCR for COVID-19

详细描述

In late December 2019, a new coronavirus strain emerged in China causing coronavirus disease 2019 (COVID19). Since then, COVID19 has become a global pandemic outbreak being declared a "public health emergency of international concern" by the International Health Regulations Emergency Committee of the WHO on January 30, 2020. The pandemic concerns to public worldwide but also to couples aiming to conceive through natural means or undergoing assisted reproductive technologies (ART). Different organizations including the American Society of Reproductive Medicine have recommended a precautionary approach. Therefore, new cycles for infertility patients as well as non-medically urgent gamete preservation treatments, such as social egg freezing, have been suspended in many countries. The decision to resume the In vitro fertilization (IVF) treatment make us to question if virus could be in gametes affecting couples and reproductive outcomes. The presence of the virus in sperm have contradictory results.

The present study aims to describe if there could be presence of virus in sperm samples of patients with positive diagnosis for COVID-19, and if so, if the virus turns negative on the sperm after the patient recovers and have a negative result for COVID-19. Also it aims to assess the presence of the virus in the seminal plasma and discern if it possible to disseminate it by sexual transmission.

An interim analysis is expected to be carried out once the 50% of the expected recruitment is achieved.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

入选标准

  • Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
  • Male age: 18 - 65 years, both included.
  • COVID-19 positive result by PCR (including symptomatic and asymptomatic subjects).

排除标准

  • Patients with severe symptoms or any other medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and his compliance in the study
  • Known medical history of azoospermia or anejaculation

结局指标

主要结局

SARS-CoV-2 semen result

时间窗: 1 day

PCR results in semen specimen samples with patient COVID-19 positive test

次要结局

  • SARS-CoV-2 semen result(2-8 weeks)

研究者

发起方
Igenomix
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验