Study of Sperm Molecular Factors Implicated in Male Fertility

NCT ID: NCT00481403

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2016-12-31

Brief Summary

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Sperm analysis following World Health Organization guidelines is unable to explain the molecular causes of male infertility when basic sperm parameters are within a normal range and women do not present gynaecological pathology.

Subsequently, there is a need for accurate diagnostic tools in this sense and microarray technology applied to sperm analysis emerges as a promising field

Detailed Description

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Sperm analysis based in sperm count and motility has been employed for the diagnosis of male fertility for several decades. It is an easy, inexpensive and useful tool to determine the fertile status of a male but there is still a significant number of infertile males with normal sperm features, as determined by the basic sperm analysis, while they remain unable to reach a full-term pregnancy (1). This fact clearly indicates the need to develop new male infertility tests and accurately diagnose the sperm samples from these individuals.

Recent investigations about sperm mRNA contents have described the relevance of the sperm mRNA stock in fertilization and early embryo development in several species. (2) Although sperm is a quiescent cell from the translational point of view, several functional mRNAs that will be delivered into the oocyte after fertilization, that were synthesized in an earlier phase of the spermatogenesis process can be found (3, 4).

The fertile male transcriptome (stock of mRNAs within the sperm of a male able to have progeny) has been already described (5, 6), confirming the expression of thousands of sequence tags with different intensity of expression.

Moreover, several investigations have demonstrated that a differential expression of some key mRNAs is found in infertile males in comparison with fertile males (1, 7).

Nevertheless, there is no information available neither about the characteristics of the stock sperm mRNAs on infertile males or the differences between fertile and infertile men, although several authors have hypothesized that sperm microarray analysis will be the future in the male infertility diagnosis (2, 8-11).

Microarray technology provides information about a wide range of mRNAs expression within a single experiment, permitting to analyze complete sperm expression profiles (SEP) in cells or tissues. Bioinformatics can help in the organization of such amount of results by following logical processes of gene expression grouping, and analyzing statistically these findings.

Our aim with this work was to compare the SEP in spermatozoa obtained from males with idiopathic infertility versus those from sperm donors of proven fertility by employing microarray technology followed by a functional analysis, in order to determine the genes, sequences and biological processes involved in the sperm physiology that are different in infertile vs. fertile males.

Conditions

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Male Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Microarray analysis

Microarray analysis

Intervention Type BEHAVIORAL

Microarray

Microarray

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Fertile (controls) or infertile males, with sperm parameters above the WHO criteria values

Exclusion Criteria

* Well established infertility causes
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Garrido

Director of Andrology IVI Valencia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas Garrido, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Universitario IVI

Locations

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Instituto Universitario Ivi

Valencia, , Spain

Site Status

Countries

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Spain

References

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1. Garrido N, Meseguer M, Alvarez J, Simon C, Pellicer A, Remohi J. Relationship among standard semen parameters, glutathione peroxidase/glutathione reductase activity, and mRNA expression and reduced glutathione content in ejaculated spermatozoa from fertile and infertile men. Fertil Steril. 2004 Oct;82 Suppl 3:1059-66. 2. Krawetz SA. Paternal contribution: New insights and future challenges. Nat Rev Genet. 2005;6:633-42. 3. Kramer JA, Krawetz SA. RNA in spermatozoa: Implications for the alternative haploid genome. Mol Hum Reprod. 1997;3:473-8. 4. Wykes SM, Visscher DW, Krawetz SA. Haploid transcripts persist in mature human spermatozoa. Mol Hum Reprod. 1997; 3:15-9.

Reference Type BACKGROUND

Other Identifiers

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VLC-NG-0506-(1003-C-068-JH)

Identifier Type: -

Identifier Source: org_study_id

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