FertilityNCT03734120
Cryogenic Preservation of Spermatozoa
An observational study of Fertility and Spermatic Parameters, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The reference technique for the conservation of gametes is storage in liquid nitrogen but new vats of nitrogen vapor (storage over liquid nitrogen) or in dry phase (storage in an insulated compartment of liquid nitrogen in a tank Liquid nitrogen) also allow the storage of flakes. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility, Spermatic Parameters
- What is being tested?
- cryopreservation
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2012to 1 Aug 2013
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand
Who may be able to join
- Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand
Who cannot join
- women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryogenic Preservation of Spermatozoa : Comparative Study Between Both Dry and Liquid Phase Nitrogen Storages
The reference technique for the conservation of gametes is storage in liquid nitrogen but new vats of nitrogen vapor (storage over liquid nitrogen) or in dry phase (storage in an insulated compartment of liquid nitrogen in a tank Liquid nitrogen) also allow the storage of flakes. The purpose of this work is to evaluate the dry-phase cryopreservation technique of liquid nitrogen compared with liquid-phase storage, depending on the duration of cryopreservation.
Read the detailed description
Objective: To evaluate the effects of cryopreserved sperm in dry and liquid phase nitrogen at 3 and 6 month on sperm numeration, motility, vitality, morphology, acrosomal integrity and DNA fragmentation.
Design: Experimental study, investigator was blinded to the type of Cryopreservation.
Patient(s): Semen samples were collected from patients who came in laboratory for semen analysis
Intervention: Samples were frozen with a programmable freezing unit. Each semen sample was divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature.
- Conditions
- Fertility, Spermatic Parameters
- Being tested
- cryopreservation
- Keywords
- Cryo preservation, Spermatic nuclear quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryopreservationOther
Samples were frozen with a programmable freezing unit. Each semen sample was divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature
| Study group | Role | What they receive |
|---|---|---|
| men | men undergoing routine semen analysis for infertility Receives: Other: cryopreservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm DNA integrity
the spermatic DNA integrity can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA
Measured: at 3 months
Sperm DNA integrity
the spermatic DNA integrity can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA
Measured: at 6 months
Secondary outcomes (4)
Sperm parameter post cryopreservation
The Sperm motility will be measured according to WHO recommendations
Measured: at 3 and 6 months
Lab parameter post cryopreservation
The Sperm motility will be measured according to WHO recommendations
Measured: at 3 and 6 months
Spermatic DNA Compaction
The spermatic DNA Compaction will be determinated by chromomycine A3 labelling (CMA3). A sperm is good when it has at least 30% of positive spermatozoa to CMA3 assay
Measured: at 3 and 6 months
Acrosomal integrity
The acrosomal integrity will be determinated by PSA-FITC labelling.
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Jun 2012
- Primary completion1 Aug 2012
- Study completion1 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BRUGNON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734120
- Sponsor's protocol ID
- CHU-413
- Status last verified
- Nov 2018
- First submitted
- 23 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryogenic Preservation of Spermatozoa : Comparative Study Between Both Dry and Liquid Phase Nitrogen Storages
- ClinicalTrials.gov ID
- NCT03734120
- Acronym / sponsor ID
- CHU-413
- Conditions
- Fertility, Spermatic Parameters
- Keywords
- Cryo preservation, Spermatic nuclear quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Aug 2012 (actual)
- Study completion
- 1 Aug 2013 (actual)
- First posted
- 7 Nov 2018 (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.
The reference technique for the conservation of gametes is storage in liquid nitrogen but new vats of nitrogen vapor (storage over liquid nitrogen) or in dry phase (storage in an insulated compartment of liquid nitrogen in a tank Liquid nitrogen) also allow the storage of flakes. The purpose of this work is to evaluate the dry-phase cryopreservation technique of liquid nitrogen compared with liquid-phase storage, depending on the duration of cryopreservation.
Detailed description
Objective: To evaluate the effects of cryopreserved sperm in dry and liquid phase nitrogen at 3 and 6 month on sperm numeration, motility, vitality, morphology, acrosomal integrity and DNA fragmentation.
Design: Experimental study, investigator was blinded to the type of Cryopreservation.
Patient(s): Semen samples were collected from patients who came in laboratory for semen analysis
Intervention: Samples were frozen with a programmable freezing unit. Each semen sample was divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| men | – | Other: cryopreservationmen undergoing routine semen analysis for infertility |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand
Key inclusion criteria (1 listed)
- Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand
Key exclusion criteria (1 listed)
- women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryopreservationSamples were frozen with a programmable freezing unit. Each semen sample was divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature | Other | men |
Primary outcome
Sperm DNA integrity
Time frame: at 3 months
the spermatic DNA integrity can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA
Sperm DNA integrity
Time frame: at 6 months
the spermatic DNA integrity can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA
4 secondary outcomes
Sperm parameter post cryopreservation
Time frame: at 3 and 6 months
Lab parameter post cryopreservation
Time frame: at 3 and 6 months
Spermatic DNA Compaction
Time frame: at 3 and 6 months
Acrosomal integrity
Time frame: at 3 and 6 months
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 Nov 2018.
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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.
Florence BRUGNON 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 Fertility and Spermatic Parameters, 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 1 inclusion and 1 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 Nov 2018. 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?
Sperm DNA integrity (time frame: at 3 months). The study lists 2 primary outcomes in all. 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 Nov 2018.