HealthyCRYOFERTNCT06448000
Effect of Long-time Human Sperm Storage in Liquid Nitrogen on Semen Parameters
An observational study of Healthy and Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 19 to 63 years, men only
- Conditions the study is for
- Healthy, Cancer, Infertility, Male
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 63 years
- Men only
- Adult
Study population: All samples frozen between 2010 and 2020 corresponding to the inclusion criteria cited above have been included in the study. In total, this corresponds to 101 eligible samples, or 202 straws, between 2010 and 2020, i.e. a T1 storage time studied from 2 to 12 years.
Who may be able to join
- 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
Who cannot join
- Ejaculate not donated to research, lack of consent to donation to research
- Frozen ejaculate in microdrop
- Thawing test not carried out or incomplete
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Storage Time in Liquid Nitrogen on Cryopreserved Human Spermatozoa
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.
Read the 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 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).
- Conditions
- Healthy, Cancer, Infertility, Male, Cryopreservation
- Keywords
- Cryopreservation, semen standard parameters, liquid nitrogen, high security straws, long term storage, progressive and total mobility
- Medical subject headings
- Neoplasms, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Same semen samples are analyzed in group 1 and 2. Group 1 correspond to ejaculate semen samples analyzed the day of slow-freezing | |
| Group 2 | Same semen samples are analyzed in group 1 and 2. Group 2 correspond to the same ejaculate semen samples as group 1 but analyzed after a storage time from 2 to 12 years in liquid nitrogen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 07/2022 to 03/2023
Secondary outcomes (2)
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.
Measured: 07/2022 to 03/2023
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.
Measured: 07/2022 to 03/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study startJan 2010
- Primary completionOct 2020
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanae Pons-Rejraji, PhD, Principal investigator, University Hospital, Clermont-FerrandFlorence Brugnon, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448000
- Sponsor's protocol ID
- 20220911-CRYOFERT
- Acronym
- CRYOFERT
- Status last verified
- Mar 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Storage Time in Liquid Nitrogen on Cryopreserved Human Spermatozoa
- ClinicalTrials.gov ID
- NCT06448000
- Acronym / sponsor ID
- CRYOFERT / 20220911-CRYOFERT
- Conditions
- Healthy, Cancer, Infertility, Male, Cryopreservation
- Keywords
- Cryopreservation, semen standard parameters, liquid nitrogen, high security straws, long term storage, progressive and total mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Same semen samples are analyzed in group 1 and 2. Group 1 correspond to ejaculate semen samples analyzed the day of slow-freezing |
| Group 2 | – | –Same semen samples are analyzed in group 1 and 2. Group 2 correspond to the same ejaculate semen samples as group 1 but analyzed after a storage time from 2 to 12 years in liquid nitrogen. |
Who may qualify
- Ages
- 19 to 63 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- All samples frozen between 2010 and 2020 corresponding to the inclusion criteria cited above have been included in the study. In total, this corresponds to 101 eligible samples, or 202 straws, between 2010 and 2020, i.e. a T1 storage time studied from 2 to 12 years.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Ejaculate not donated to research, lack of consent to donation to research
- Frozen ejaculate in microdrop
- Thawing test not carried out or incomplete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate and compare the total and progressive mobility of human spermatozoa post-freezing and post-storage in High Security straws.
Time frame: 07/2022 to 03/2023
The percentage of total and progressive motile human spermatozoa were assessed according to WHO, 2010 guideline.
2 secondary outcomes
To compare the vitality of post-freezing and post-storage human spermatozoa
Time frame: 07/2022 to 03/2023
To compare the number of motile, total and progressive spermatozoa post-freezing and post-storage
Time frame: 07/2022 to 03/2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanae Pons-Rejraji, PhD principal investigator
University Hospital, Clermont-Ferrand
Florence Brugnon, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Cancer, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate and compare the total and progressive mobility of human spermatozoa post-freezing and post-storage in High Security straws. (time frame: 07/2022 to 03/2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.