Cryogenic Preservation of Spermatozoa

Completed

• Conditions: Spermatic Parameters; Fertility
• Interventions: Other: cryopreservation

• Registration Number: NCT03734120
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

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 Timeline

• Study Start: 2012-06-01
• Primary Completion: 2012-08-01
• Study Completion: 2013-08-01
• Study First Submitted: 2018-10-23
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Study First Posted: 2018-11-07
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

• women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
men	cryopreservation	men undergoing routine semen analysis for infertility

Primary Outcome Measures

Name	Time	Method
Sperm DNA integrity	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

Name	Time	Method
Spermatic DNA Compaction	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
Acrosomal integrity	at 3 and 6 months	The acrosomal integrity will be determinated by PSA-FITC labelling.
Sperm parameter post cryopreservation	at 3 and 6 months	The Sperm motility will be measured according to WHO recommendations
Lab parameter post cryopreservation	at 3 and 6 months	The Sperm motility will be measured according to WHO recommendations

Trial Locations

Locations (1)

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France