Human Sperm Markers of Cryodamage Resistance

February 9, 2021 updated by: Elena Sellés Soriano, Instituto Valenciano de Infertilidad, IVI Alicante

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03015
        • IVI Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High cryoresistance
High resistance to sperm cryopreservation (decreased sperm motility <20%)
Other: Sperm cryopreservation
Sperm from the different groups are cryopreserved to evaluate their resistance to preservation.
Low cryoresistance
Low resistance to sperm cryopreservation (decreased sperm motility >20%)
Other: Sperm cryopreservation
Sperm from the different groups are cryopreserved to evaluate their resistance to preservation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
A year and a half

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI Alicante

Collaborators

Igenomix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 12, 2015

Primary Completion (ACTUAL)

November 12, 2018

Study Completion (ACTUAL)

December 12, 2019

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (ESTIMATE)

August 28, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1406-ALC-048-ES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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