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Cryogenic Preservation of Spermatozoa

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ClinicalTrials.gov Identifier: NCT03734120
Recruitment Status : Completed
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Fertility Spermatic Parameters Other: 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
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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cryogenic Preservation of Spermatozoa : Comparative Study Between Both Dry and Liquid Phase Nitrogen Storages
Actual Study Start Date : June 1, 2012
Actual Primary Completion Date : August 1, 2012
Actual Study Completion Date : August 1, 2013
Groups and Cohorts
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Group/Cohort Intervention/treatment
men
men undergoing routine semen analysis for infertility
 Other: cryopreservation
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Sperm parameter post cryopreservation [ Time Frame: at 3 and 6 months ]
    The Sperm motility will be measured according to WHO recommendations

  2. Lab parameter post cryopreservation [ Time Frame: at 3 and 6 months ]
    The Sperm motility will be measured according to WHO recommendations

  3. Spermatic DNA Compaction [ Time Frame: at 3 and 6 months ]
    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

  4. Acrosomal integrity [ Time Frame: at 3 and 6 months ]
    The acrosomal integrity will be determinated by PSA-FITC labelling.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand
Criteria

Inclusion Criteria:

  • Men undergoing routine semen analysis for infertility for reproductive medicine of university hospital in Clermont-Ferrand

Exclusion Criteria:

  • women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734120


Locations
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France
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Florence BRUGNON University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03734120    
Other Study ID Numbers: CHU-413
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Cryo preservation
Spermatic nuclear quality