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Completed

NCT Number: NCT02535377

Human Sperm Markers of Cryodamage Resistance

Sperm freezing has been employed for decades for male fertility preservation in cases of foreseeable or unexpected loss of fertility to guarantee future paternity, and also as a complement of assisted reproduction techniques.

Sperm quality after thawing is highly variable, even among consecutive samples from the same individual, with mean survival rates around 40%. To date, the molecular basis of the adequate resistance or intolerance to freezing/thawing protocols is unknown, and its knowledge can lead to improvement in the selection of the samples to be frozen and also in the adequate supplement of cryopreservation media. Microarray analysis provides a powerful tool to address the molecular explanation beyond this behaviour, yielding results about comparative messenger ribonucleic acid (mRNA)expression under the two different biological conditions: optimal and suboptimal survival.

Then, the aim of the investigators' study is to determine the genomic profile of sperm samples depending on their survival resistance to cryopreservation, to determine genes involved in cryodamage sensitivity.

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Key information

Conditions

Fertility

Age range

18 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

IVI Alicante

Alicante, 03015, Spain

About this study

Nested cases and controls design, with donor sperm samples frozen under conventional protocols, categorized depending on their good (GSR, n=20) (less than 20% motility decrease) or bad (BSR, n=20) (more than 20% motility decrease) survival rates. Sperm mRNA was extracted using Trizol protocol, suspended in diethylpyrocarbonate (DEPC)-treated water and frozen at -80 degrees until the microarray experiments were performed. RNAs were analyzed on Agilent Bioanalyzer 2100. Samples were pooled in 4 (5 samples/pool and 4 pools/group). Finally, 8 Agilent One colour Whole genome microarray (44K) were performed with pooled samples, 4 microarrays per group.

The results will be evaluate to detect those genes differentially expressed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The criteria used for the inclusion of donors in the sperm bank will be considered:

  • males from 18 to 35 years.
  • good physical and psychological conditions and no hereditary diseases
  • seminal parameters: concentration > 40 million sperm / ml; percentage of progressive motility> 50% percentage of normal forms> 4%.
  • For pregnancy rates after artificial insemination, only women< 40 years without tubal pathologies and artificial insemination indications will be included.

Exclusion criteria

All the population not included in the list of inclusion will be excluded.

Treatment and study plan

Sperm cryopreservation

Other

Sperm from the different groups are cryopreserved to evaluate their resistance to preservation.

Primary outcomes

  1. Genomic profile of sperm samples depending on their survival resistance to cryopreservation

    Time frame: A year and a half

    The genomic profile of sperm samples depending on their survival resistance to cryopreservation will be analysed and expressed as:

    • Common or differentially expressed genes: in case of genes expressed in both groups
    • Exclusive Genes, in case of genes expressed just in one group

Secondary outcomes

  1. Pregnancy rates after artificial insemination with donor semen in the different groups.

    Time frame: two years

    Once obtained the genomic profile of samples from donors included the different groups, we will analyze its relationship with the reproductive outcomes, in particular pregnancy rates after conventional artificial insemination (percentage of positive pregnancy test)

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI Alicante

Other

Collaborators

  • Igenomix

Registry information

Official study title

Molecular Diagnostic of Sperm Cryoresistance of Semen Donors and Clinical Outcomes After Artificial Insemination. Optimization of Sperm Bank

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Aug 28, 2015
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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