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
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.
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.
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
Hospital Ruber Internacional
Madrid, Spain
Investigator: Jesus Maria R Franco
Contact: +34913875000
jesusm.franco@ruberinternacional.es
Carlos Gomez, BSc, MSc
+34963905310
carlos.gomez@igenomix.com