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

NCT ID: NCT04717011

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-07-31

Brief 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

Detailed 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.

Conditions

SARS-CoV-2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Igenomix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Simon, MD, PhD

Role: STUDY_CHAIR

Igenomix

Nasser Al-Asmar, PhD

Role: PRINCIPAL_INVESTIGATOR

Igenomix

Locations

Hospital Ruber Internacional

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carlos Gomez, BSc, MSc

Role: CONTACT

carlos.gomez@igenomix.com

+34963905310

Facility Contacts

Jesus Maria R Franco

Role: primary

jesusm.franco@ruberinternacional.es

+34913875000

Other Identifiers

IGX1-COV-NA-20-05

Identifier Type: -

Identifier Source: org_study_id