Case Series Study to Detect SARS-CoV-2 in Semen of COVID-19 Patients

SARS-CoV-2 Clinical Trial

— COVID-19CAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717011
• Other study ID #: IGX1-COV-NA-20-05
• Status: Recruiting
• Start date: February 2021
• Est. completion date: July 2021

Study information

• Verified date: January 2021
• Source: Igenomix
• Contact: Carlos Gomez, BSc, MSc
• Phone: +34963905310
• Email: carlos.gomez[@]igenomix.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Diagnostic Test:
• PCR test
PCR test in two different semen samples from each patient: first with positive diagnosis for COVID-19 and the second after negative diagnosis for COVID-19.

Locations

Country	Name	City	State
Spain	Hospital Ruber Internacional	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Igenomix

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 semen result	PCR results in semen specimen samples with patient COVID-19 positive test	1 day
Secondary	SARS-CoV-2 semen result	PCR results in semen specimen samples with patient COVID-19 negative test	2-8 weeks