Impact of Cryopreservation Methods on Post-Thaw SARS-CoV-2 in Semen Samples (NCT06703723) | Clinical Trial Compass
CompletedNot Applicable
Impact of Cryopreservation Methods on Post-Thaw SARS-CoV-2 in Semen Samples
Italy40 participantsStarted 2021-01-14
Plain-language summary
Cryopreservation of seminal fluid or spermatozoa from epididymary and testicular retrieval represents a crucial tool in managing conditions of permanent or temporary infertility, as well as in cases of secretory and excretory azoospermia. These pathologies often affect young men and children, making it essential to maintain fertility through cryopreservation methods such as vitrification or two-step cryopreservation of human semen.
The burden of the SARS-CoV-2 virus has rapidly evolved. SARS-CoV-2 causes respiratory, cardiovascular, digestive, and urinary infections, yet no studies have explored its effects on the reproductive system. Recent findings confirm the expression of the virus receptor (ACE2) on certain testicular cells, including Sertoli cells, Leydig cells, and spermatogonia, which could significantly impact fertility and cryopreservation practices.
This study aims to utilize semen samples from individuals exposed to SARS-CoV-2 infection to perform two different cryopreservation procedures, evaluating virus behavior and effects. The objective is to determine whether it is safer to cryopreserve the entire volume of the sample or perform gradient separation to isolate the virus from spermatozoa, potentially establishing a new cryopreservation protocol specific to SARS-CoV-2.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient population inclusion criteria:
* • Male subjects, aged 18-50 requiring a semen fluid evaluation.
* Positive IgG serological test result performed not more than 3 months before recruitment
* Signed informed consent
* Anamnestic test compilation
Control subject inclusion criteria:
* Male subjects, aged 18-50 requiring a semen fluid evaluation.
* Negative IgG serological test result performed within the last month
* Signed informed consent
* Anamnestic test compilation
Exclusion Criteria:
* Patient population exclusion criteria:
* Severe male Factor (azoospermia and \<200,00 sperm per ejaculate)
* Fever (\>38.5 C) in the 60 days before enrollment
* Treated with antibiotic at the time of enrolment or two months before enrolment
* Treated with cortisone at the time of enrolment or two months before enrolment
Control subject population exclusion criteria:
* Severe male Factor (azoospermia and \<200,00 sperm per ejaculate)
* Fever (\>38.5 C) in the 60 days before enrolment
* Known history of SARS-CoV-2 infection
* Treated with antibiotic at the time of enrolment or two months before enrolment
* Treated with cortisone at the time of enrolment or two months before enrolment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
nvestigation of ACE2 and TMPRSS2 mRNA Expression on Spermatozoa in SARS-CoV-2 Infected Semen Samples
Timeframe: through study completion, an average of 1 year