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Completed

NCT Number: NCT03734120

Cryogenic Preservation of Spermatozoa

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.

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Key information

Conditions

Fertility Spermatic Parameters

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • women

Treatment and study plan

cryopreservation

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Cryogenic Preservation of Spermatozoa : Comparative Study Between Both Dry and Liquid Phase Nitrogen Storages

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Nov 7, 2018
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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