Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448000
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Effect of Long-time Human Sperm Storage in Liquid Nitrogen on Semen Parameters
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Impact of Storage Time in Liquid Nitrogen on Cryopreserved Human Spermatozoa
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRYOFERT
Brief Summary:
Sperm cryopreservation is an essential tool for men fertility preservation in the context of gonadotoxic treatments orand pathologies such as cancers gamete donation and ART Nevertheless it is validated that the freezing and thawing procedures affect sperm parameters and in particular motility It is therefore essential to determine the impact of storage time on motility and particularly the number of progressive motile spermatozoa which will determine the choice of ART technique However few studies have analyzed the impact of storage time in liquid nitrogen and no study over a long period on human spermatozoa and their use in ART
The aim of this study is to assess the impact of long-time storage from 2 to 12 years in liquid nitrogen on standard semen parameters notably motility
The aim of this study is to assess the impact of long-time storage from 2 to 12 years in liquid nitrogen on standard semen parameters notably motility
Detailed Description:
It has been demonstrated in the literature that cryopreservation of semen samples in liquid nitrogen guaranty good post thawing motility recovery However the literature is scarce and relatively old Moreover studies only described very small samples cohort and do not specify in which container the samples are stored There are currently no published studies on high security straws which are widely used for semen cryopreservation worldwide
The aim of this study is to assess the impact of long-time storage from 2 to 12 years in high security straws in liquid nitrogen on human standard semen parameters notably on motility
Hundred and one cryopreserved semen samples between 2010 to 2020 were donated to research by patients monitored in the unit of Assisted Reproductive Technology - Conservation of human sperm and eggs ART-CECOS Unit of the University Hospital of Clermont-Ferrand for fertility preservation Only samples corresponding to the inclusion criteria below were included in the study without distinction of bio clinical criteria
All analyzed samples have been cryopreserved following the same protocol in high security 03ml straws with the same cryoprotectant and using the same programmable freezer Nanodigitcool CryoBiosystem
The day of cryopreservation a post-freezing test T0 was caried by thawing a straw and by assessing sperm count motility and vitality according to WHO guidelines 2010
After a storage time from 2 to 12 years a second post-freezing test T1 was caried by thawing two straws and by assessing sperm count motility and vitality in the same way as T0
The statistical difference concordance correlation and diagnostic agreement between T0 and T1 were analyzed
This study is the first to assess the integrity of human sperm after a long-time cryopreservation in liquid nitrogen on a large cohort more than 100 samples
The aim of this study is to assess the impact of long-time storage from 2 to 12 years in high security straws in liquid nitrogen on human standard semen parameters notably on motility
Hundred and one cryopreserved semen samples between 2010 to 2020 were donated to research by patients monitored in the unit of Assisted Reproductive Technology - Conservation of human sperm and eggs ART-CECOS Unit of the University Hospital of Clermont-Ferrand for fertility preservation Only samples corresponding to the inclusion criteria below were included in the study without distinction of bio clinical criteria
All analyzed samples have been cryopreserved following the same protocol in high security 03ml straws with the same cryoprotectant and using the same programmable freezer Nanodigitcool CryoBiosystem
The day of cryopreservation a post-freezing test T0 was caried by thawing a straw and by assessing sperm count motility and vitality according to WHO guidelines 2010
After a storage time from 2 to 12 years a second post-freezing test T1 was caried by thawing two straws and by assessing sperm count motility and vitality in the same way as T0
The statistical difference concordance correlation and diagnostic agreement between T0 and T1 were analyzed
This study is the first to assess the integrity of human sperm after a long-time cryopreservation in liquid nitrogen on a large cohort more than 100 samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None