NCT03734120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

October 23, 2018

Last Update Submit

November 6, 2018

Conditions

Keywords

Cryo preservationSpermatic nuclear quality

Outcome Measures

Primary Outcomes (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

    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

    at 6 months

Secondary Outcomes (4)

  • Sperm parameter post cryopreservation

    at 3 and 6 months

  • Lab parameter post cryopreservation

    at 3 and 6 months

  • Spermatic DNA Compaction

    at 3 and 6 months

  • Acrosomal integrity

    at 3 and 6 months

Study Arms (1)

men

men undergoing routine semen analysis for infertility

Other: cryopreservation

Interventions

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

men

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Interventions

Cryopreservation

Intervention Hierarchy (Ancestors)

Tissue PreservationHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesPreservation, BiologicalTherapeuticsInvestigative Techniques

Study Officials

  • Florence BRUGNON

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

November 7, 2018

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2013

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations