Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06448000 |
| Other study ID # |
20220911-CRYOFERT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2010 |
| Est. completion date |
March 2023 |
Study information
| Verified date |
March 2024 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Sperm cryopreservation is an essential tool for men fertility preservation in the context of
gonadotoxic treatments or/and 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.
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
0,3ml 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).
