Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-02 @ 4:23 PM
Study NCT ID:
NCT01859520
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-21', 'studyFirstSubmitDate': '2013-03-25', 'studyFirstSubmitQcDate': '2013-05-21', 'lastUpdatePostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the rate of DNA fragmentation of spermatozoa after sperm preparation with either swim-up or density gradient techniques.', 'timeFrame': 'DNA fragmentation assay is performed just before and immediately after the sperm preparation is completed. The time frame is within an hour.', 'description': 'The change in the rate of DNA fragmented spermatozoa will be assessed before and immediately after the sperm preparation is completed, because DNA fragmentation of spermatozoa may be increased in time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spermatozoa', 'DNA fragmentation', 'Swim-up', 'Density gradient'], 'conditions': ['Male Infertility', 'Unexplained Infertility']}, 'descriptionModule': {'briefSummary': 'Sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. Most commonly used sperm preparation methods are the swim up and the density gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to the success in assisted reproduction techniques. Sperm preparation methods may theoretically cause damage to sperm DNA. Therefore it is important to select the optimum method of sperm preparation causing least sperm DNA damage. Aim of our study is to investigate and compare the effect two different sperm preparation techniques on DNA fragmentation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale factor subfertile group:\n\nCouples of having at least two abnormal sperm analysis according to WHO criteria.\n\nUnexplained subfertile group:\n\nCouples with normal sperm parameters, plus females with normal ovulatory status and patent fallopian tubes by hysterosalpingography or laparoscopy.\n\nNo previous IVF or IUI attempts before the study\n\nExclusion Criteria:\n\nSevere oligospermia (Sperm count \\< 5 Millions/ per ml) Systemic diseases or therapies influencing DNA integrity for male partner'}, 'identificationModule': {'nctId': 'NCT01859520', 'briefTitle': 'Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Effect of Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa', 'orgStudyIdInfo': {'id': 'Gazi University 01/2011-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Swim up, density gradient', 'description': 'swim-up and density gradient sperm preparation techniques in male factor infertility and unexplained infertility groups', 'interventionNames': ['Procedure: swim-up, density gradient sperm preparation techniques']}], 'interventions': [{'name': 'swim-up, density gradient sperm preparation techniques', 'type': 'PROCEDURE', 'description': 'Sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. Most commonly used sperm preparation methods are the swim up and the density gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to the success in assisted reproduction techniques. Sperm preparation methods may theoretically cause damage sperm DNA. Therefore it is important to select the optimum method of sperm preparation causing least sperm DNA damage. Aim of our study is to investigate and compare the effect two different sperm preparation techniques on DNA fragmentation.', 'armGroupLabels': ['Swim up, density gradient']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ahmet erdem, Professsor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Gazi School of Medicine Department of Obstetrics and Gynecology'}, {'name': 'Yuksel Oguz, Resident, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Gazi School Of Medicine Department of Obstetrics and Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Prof Ahmet ERDEM, MD', 'investigatorAffiliation': 'Gazi University'}}}}