Effect of Long-time Human Sperm Storage in Liquid Nitrogen on Semen Parameters

NCT06448000 | Completed

• 1 other identifier: 20220911-CRYOFERT
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Sperm cryopreservation is an essential tool for men fertility preservation in the context of gonadotoxic treatments or/and pathologies such as cancers, gamete donation and ART. Nevertheless, it is validated that the freezing and thawing procedures affect sperm parameters and in particular motility. It is therefore essential to determine the impact of storage time on motility and particularly the number of progressive motile spermatozoa which will determine the choice of ART technique. However, few studies have analyzed the impact of storage time in liquid nitrogen and no study over a long period on human spermatozoa and their use in ART. The aim of this study is to assess the impact of long-time storage, from 2 to 12 years, in liquid nitrogen on standard semen parameters, notably motility.

Conditions

Healthy; Cancer; Infertility, Male; Cryopreservation

Keywords

Cryopreservation; semen standard parameters; liquid nitrogen; high security straws; long term storage; progressive and total mobility

Outcome Measures

Primary Outcomes (1)

• To evaluate and compare the total and progressive mobility of human spermatozoa post-freezing and post-storage in High Security straws.

  The percentage of total and progressive motile human spermatozoa were assessed according to WHO, 2010 guideline.

  07/2022 to 03/2023

Secondary Outcomes (2)

• To compare the vitality of post-freezing and post-storage human spermatozoa

  07/2022 to 03/2023

• To compare the number of motile, total and progressive spermatozoa post-freezing and post-storage

  07/2022 to 03/2023

Study Arms (2)

Group 1

Same semen samples are analyzed in group 1 and 2. Group 1 correspond to ejaculate semen samples analyzed the day of slow-freezing

Group 2

Same semen samples are analyzed in group 1 and 2. Group 2 correspond to the same ejaculate semen samples as group 1 but analyzed after a storage time from 2 to 12 years in liquid nitrogen.

Eligibility Criteria

• Age: 19 Years - 63 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All samples frozen between 2010 and 2020 corresponding to the inclusion criteria cited above have been included in the study. In total, this corresponds to 101 eligible samples, or 202 straws, between 2010 and 2020, i.e. a T1 storage time studied from 2 to 12 years.

You may qualify if:

• The ejaculates were frozen in high security straws by slow freezing,
• At least two straws per sample were available
• The "post-freezing" thawing test was carried out on the day of freezing
• The "post-freezing" thawing test carried out at T0 includes cell numbering, vitality and mobility
• There is the informed signature of the consent to donate the straws to Research by the patient

You may not qualify if:

• Ejaculate not donated to research, lack of consent to donation to research
• Frozen ejaculate in microdrop
• Thawing test not carried out or incomplete

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

University Hospital

Clermont-Ferrand, 63100, France

Location

MeSH Terms

Conditions

Neoplasms; Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Hanae Pons-Rejraji, PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

• Florence Brugnon, MD, PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: January 1, 2010
• Primary Completion: October 1, 2020
• Study Completion: March 1, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-03

Locations

FR (1)