Cryogenic Preservation of Spermatozoa

Fertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734120
• Other study ID #: CHU-413
• Status: Completed
• Start date: June 1, 2012
• Est. completion date: August 1, 2013

Study information

• Verified date: November 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 1, 2013
• Est. primary completion date: August 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• women

Related Conditions & MeSH terms

• Fertility
• Spermatic Parameters

Intervention

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

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sperm parameter post cryopreservation	The Sperm motility will be measured according to WHO recommendations	at 3 and 6 months
Secondary	Lab parameter post cryopreservation	The Sperm motility will be measured according to WHO recommendations	at 3 and 6 months
Secondary	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	at 3 and 6 months
Secondary	Acrosomal integrity	The acrosomal integrity will be determinated by PSA-FITC labelling.	at 3 and 6 months