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CompletedNCT03734120Updated Nov 7, 2018

Cryogenic Preservation of Spermatozoa

An observational study in Fertility and Spermatic Parameters, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-07.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 60 Years
Sex
Male
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Study 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.

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.

02

Conditions studied

  • Fertility
  • Spermatic Parameters

Keywords

  • Cryo preservation
  • Spermatic nuclear quality
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • women
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • men

    men undergoing routine semen analysis for infertility

    Other: cryopreservation

Interventions

  • Othercryopreservation

    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

06

What researchers measure

Primary outcomes

  1. Sperm DNA integrity

    the spermatic DNA integrity can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA

    Time frame: at 3 months

  2. Sperm DNA integrity

    the spermatic DNA integrity can be quantified by TUNEL method. The result will be expressed as a percentage of fragmented DNA

    Time frame: at 6 months

Secondary outcomes

  1. Sperm parameter post cryopreservation

    The Sperm motility will be measured according to WHO recommendations

    Time frame: at 3 and 6 months

  2. Lab parameter post cryopreservation

    The Sperm motility will be measured according to WHO recommendations

    Time frame: at 3 and 6 months

  3. 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

    Time frame: at 3 and 6 months

  4. Acrosomal integrity

    The acrosomal integrity will be determinated by PSA-FITC labelling.

    Time frame: at 3 and 6 months

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Study locations

1 site
  • Chu Clermont-Ferrand
    Clermont-Ferrand, 63003, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03734120
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Nov 7, 2018
Start date
Jun 1, 2012
Primary completion
Aug 1, 2012
Completion
Aug 1, 2013
Last update
Nov 7, 2018

Study contacts

Florence BRUGNON
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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