Human Sperm Markers of Cryodamage Resistance

NCT02535377 | Completed DMC

• 1 other identifier: 1406-ALC-048-ES
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fertility

Keywords

Cryodamage; microarrays; Insemination; sperm

Outcome Measures

Primary Outcomes (1)

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

  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

  A year and a half

Secondary Outcomes (1)

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

  two years

Study Arms (2)

High cryoresistance

High resistance to sperm cryopreservation (decreased sperm motility \<20%)

Other: Sperm cryopreservation

Low cryoresistance

Low resistance to sperm cryopreservation (decreased sperm motility \>20%)

Other: Sperm cryopreservation

Interventions

Sperm cryopreservation OTHER

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

High cryoresistance; Low cryoresistance

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men from 18-35 years, included in the donation program of IVI Alicante. Any transmisible clinical pathology, viral infection or genetic disease should be ruled out by family history records. In addition, seminal samples from donors must meet the seminal criteria considered by our laboratory: * sperm concentration\> 40 million sperm / ml; * percentage of progressive motility\> 50% * percentage of normal forms\> 4%. For pregnancy rates after IUI, only women\< 40 years without tubal pathologies and IUI indications will be included.

You may qualify if:

• 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.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI Alicante: lead
• Igenomix: collaborator

Study Sites (1)

IVI Alicante

Alicante, 03015, Spain

Location

Related Publications (9)

• Thurston LM, Siggins K, Mileham AJ, Watson PF, Holt WV. Identification of amplified restriction fragment length polymorphism markers linked to genes controlling boar sperm viability following cryopreservation. Biol Reprod. 2002 Mar;66(3):545-54. doi: 10.1095/biolreprod66.3.545.

  PMID: 11870056 BACKGROUND

• Thurston LM, Watson PF, Holt WV. Semen cryopreservation: a genetic explanation for species and individual variation? Cryo Letters. 2002 Jul-Aug;23(4):255-62.

  PMID: 12391486 BACKGROUND

• Holt WV, Medrano A, Thurston LM, Watson PF. The significance of cooling rates and animal variability for boar sperm cryopreservation: insights from the cryomicroscope. Theriogenology. 2005 Jan 15;63(2):370-82. doi: 10.1016/j.theriogenology.2004.09.018.

  PMID: 15626405 BACKGROUND

• Casas I, Sancho S, Briz M, Pinart E, Bussalleu E, Yeste M, Bonet S. Freezability prediction of boar ejaculates assessed by functional sperm parameters and sperm proteins. Theriogenology. 2009 Oct 15;72(7):930-48. doi: 10.1016/j.theriogenology.2009.07.001. Epub 2009 Aug 3.

  PMID: 19651432 BACKGROUND

• Garrido N, Martinez-Conejero JA, Jauregui J, Horcajadas JA, Simon C, Remohi J, Meseguer M. Microarray analysis in sperm from fertile and infertile men without basic sperm analysis abnormalities reveals a significantly different transcriptome. Fertil Steril. 2009 Apr;91(4 Suppl):1307-10. doi: 10.1016/j.fertnstert.2008.01.078. Epub 2008 Mar 25.

  PMID: 18367176 BACKGROUND

• Garcia-Herrero S, Meseguer M, Martinez-Conejero JA, Remohi J, Pellicer A, Garrido N. The transcriptome of spermatozoa used in homologous intrauterine insemination varies considerably between samples that achieve pregnancy and those that do not. Fertil Steril. 2010 Sep;94(4):1360-1373. doi: 10.1016/j.fertnstert.2009.07.1671. Epub 2009 Sep 30.

  PMID: 19796764 BACKGROUND

• Garcia-Herrero S, Garrido N, Martinez-Conejero JA, Remohi J, Pellicer A, Meseguer M. Ontological evaluation of transcriptional differences between sperm of infertile males and fertile donors using microarray analysis. J Assist Reprod Genet. 2010 Feb;27(2-3):111-20. doi: 10.1007/s10815-010-9388-5. Epub 2010 Feb 2.

  PMID: 20127162 BACKGROUND

• Rahana AR, Ng SP, Leong CF, Rahimah MD. Comparison between mechanical freezer and conventional freezing using liquid nitrogen in normozoospermia. Singapore Med J. 2011 Oct;52(10):734-7.

  PMID: 22009393 BACKGROUND

• Gadea J, Molla M, Selles E, Marco MA, Garcia-Vazquez FA, Gardon JC. Reduced glutathione content in human sperm is decreased after cryopreservation: Effect of the addition of reduced glutathione to the freezing and thawing extenders. Cryobiology. 2011 Feb;62(1):40-6. doi: 10.1016/j.cryobiol.2010.12.001. Epub 2010 Dec 13.

  PMID: 21156167 BACKGROUND

Study Officials

• Elena Sellés, PhD

  Instituto Valenciano de Infertilidad, IVI Alicante

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Molecular diagnostic of sperm cryoresistance of semen donors and clinical outcomes after artificial insemination. Optimization of sperm bank

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: August 28, 2015
• Study Start: February 12, 2015
• Primary Completion: November 12, 2018
• Study Completion: December 12, 2019
• Last Updated: February 10, 2021

Record last verified: 2020-01

Locations

ES (1)