Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-04-11 @ 2:07 PM
Study NCT ID:
NCT00481403
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2007-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Sperm Molecular Factors Implicated in Male Fertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}], 'ancestors': [{'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'After sperm washing, sperm pellet was suspended in trizol and immediately frozen by direct immersion in liquid nitrogen and stored in a nitrogen tank until mRNA extraction.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2007-05-31', 'studyFirstSubmitQcDate': '2007-05-31', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm mRNAs expression profile in samples achieving pregnancy vs those who failed in different assisted reproduction techniques', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sperm, male fertility, microarrays'], 'conditions': ['Male Infertility']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSubsequently, there is a need for accurate diagnostic tools in this sense and microarray technology applied to sperm analysis emerges as a promising field', 'detailedDescription': '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.\n\nRecent 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).\n\nThe 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.\n\nMoreover, several investigations have demonstrated that a differential expression of some key mRNAs is found in infertile males in comparison with fertile males (1, 7).\n\nNevertheless, 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).\n\nMicroarray 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.\n\nOur 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile male undergoing assisted reproduction technique without abnormal sperm parameters described by the OMS. Female partners are under 37 years old, IBM lower than 30 kg/m2 and do not present any obvious infertility problem as fallopian tubal obstruction, endometriosis, ovarian failure or polycystic ovarian syndrome.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fertile (controls) or infertile males, with sperm parameters above the WHO criteria values\n\nExclusion Criteria:\n\n* Well established infertility causes'}, 'identificationModule': {'nctId': 'NCT00481403', 'briefTitle': 'Study of Sperm Molecular Factors Implicated in Male Fertility', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Microarray Analysis in Sperm From Fertile and Infertile Males Without Basic Sperm Analysis Abnormalities', 'orgStudyIdInfo': {'id': 'VLC-NG-0506-(1003-C-068-JH)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Microarray analysis', 'type': 'BEHAVIORAL', 'description': 'Microarray analysis'}, {'name': 'Microarray', 'type': 'BEHAVIORAL', 'description': 'Microarray'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Universitario Ivi', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Nicolas Garrido, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Universitario IVI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Andrology IVI Valencia', 'investigatorFullName': 'Nicolas Garrido', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}