Clinical Trials Logo

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).


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date March 2023
Est. primary completion date October 2020
Accepts healthy volunteers
Gender Male
Age group 19 Years to 63 Years
Eligibility Inclusion Criteria: - The ejaculates were frozen in high security straws by slow freezing, - At least two straws per sample were available - The "post-freezing" thawing test was carried out on the day of freezing - The "post-freezing" thawing test carried out at T0 includes cell numbering, vitality and mobility - There is the informed signature of the consent to donate the straws to Research by the patient Exclusion Criteria: - Ejaculate not donated to research, lack of consent to donation to research - Frozen ejaculate in microdrop - Thawing test not carried out or incomplete

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France University Hospital Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate and compare the total and progressive mobility of human spermatozoa post-freezing and post-storage in High Security straws. The percentage of total and progressive motile human spermatozoa were assessed according to WHO, 2010 guideline. 07/2022 to 03/2023
Secondary To compare the vitality of post-freezing and post-storage human spermatozoa The percentage of alive human spermatozoa were assessed according to WHO, 2010 guideline. 07/2022 to 03/2023
Secondary To compare the number of motile, total and progressive spermatozoa post-freezing and post-storage The number of motile human spermatozoa were assessed according to WHO, 2010 guideline. 07/2022 to 03/2023
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1