AzTrials
AzTrials

FertilityNCT02535377

Human Sperm Markers of Cryodamage Resistance

An observational study of Fertility, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Fertility
What is being tested?
Sperm cryopreservation
How many people
40 participants
Where
1 siteSpain
Study dates
12 Feb 2015to 12 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • IVI Alicante

    Alicante, 03015

Other trials in Spain

About this study

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

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.

Read the detailed description

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.

Conditions
Fertility
Being tested
Sperm cryopreservation
Keywords
Cryodamage, microarrays, Insemination, sperm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sperm cryopreservationOther

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

Study groups in NCT02535377
Study groupRoleWhat they receive
High cryoresistanceHigh resistance to sperm cryopreservation (decreased sperm motility <20%)
Receives: Other: Sperm cryopreservation
Low cryoresistanceLow resistance to sperm cryopreservation (decreased sperm motility >20%)
Receives: Other: Sperm cryopreservation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: A year and a half

Secondary outcomes (1)

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

    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)

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2015 (estimated)
  2. Study start12 Feb 2015
  3. Primary completion12 Nov 2018
  4. Study completion12 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02535377
Sponsor's protocol ID
1406-ALC-048-ES
Status last verified
Jan 2020
First submitted
2 Jul 2015
Last updated
10 Feb 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11870056

  • 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.

    PubMed 12391486

  • 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.

    PubMed 15626405

  • 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.

    PubMed 19651432

  • 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.

    PubMed 18367176

  • 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.

    PubMed 19796764

  • 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.

    PubMed 20127162

  • 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.

    PubMed 22009393

  • 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.

    PubMed 21156167

Questions about this trial

What is this clinical trial studying?

An observational study of Fertility, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genomic profile of sperm samples depending on their survival resistance to cryopreservation (time frame: A year and a half). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02535377, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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