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NCT06703723: SEM-COV-19
Impact of Cryopreservation Methods on Post-Thaw SARS-CoV-2 in Semen Samples
trial in COVID 19 in 40 participants. Completed in 16 April 2021.
16 April 2021
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 14 January 2021 |
| Primary completion | 16 April 2021 |
| Estimated completion | 16 April 2021 |
| Sites | 1 location across Italy |
Conditions studied
- COVID 19 — all drugs for COVID 19 →
Sponsor
Istituto Clinico Humanitas
Who can join
Adults 18 to 50, male only, with COVID 19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06703723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Istituto Clinico Humanitas trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06703723 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 25 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06703723.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing