Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02488434
Status:
COMPLETED
Last Update Posted:
2016-08-12
First Post:
2015-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-11', 'studyFirstSubmitDate': '2015-06-26', 'studyFirstSubmitQcDate': '2015-07-01', 'lastUpdatePostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The number of freezing embryos', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'increase fertilisation rate', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rates', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ICSI', 'sperm selection', 'fertile chip', 'ıcsı outcomes'], 'conditions': ['Unexplained Infertility']}, 'referencesModule': {'references': [{'pmid': '1361459', 'type': 'BACKGROUND', 'citation': 'Collins JA, Crosignani PG. Unexplained infertility: a review of diagnosis, prognosis, treatment efficacy and management. Int J Gynaecol Obstet. 1992 Dec;39(4):267-75. doi: 10.1016/0020-7292(92)90257-j.'}, {'pmid': '7060767', 'type': 'BACKGROUND', 'citation': 'Templeton AA, Penney GC. The incidence, characteristics, and prognosis of patients whose infertility is unexplained. Fertil Steril. 1982 Feb;37(2):175-82. doi: 10.1016/s0015-0282(16)46035-8.'}, {'pmid': '11113773', 'type': 'BACKGROUND', 'citation': 'Zini A, Finelli A, Phang D, Jarvi K. Influence of semen processing technique on human sperm DNA integrity. Urology. 2000 Dec 20;56(6):1081-4. doi: 10.1016/s0090-4295(00)00770-6.'}, {'pmid': '24753434', 'type': 'BACKGROUND', 'citation': 'Asghar W, Velasco V, Kingsley JL, Shoukat MS, Shafiee H, Anchan RM, Mutter GL, Tuzel E, Demirci U. Selection of functional human sperm with higher DNA integrity and fewer reactive oxygen species. Adv Healthc Mater. 2014 Oct;3(10):1671-9. doi: 10.1002/adhm.201400058. Epub 2014 Apr 17.'}, {'pmid': '6336697', 'type': 'BACKGROUND', 'citation': 'Moghissi KS, Wallach EE. Unexplained infertility. Fertil Steril. 1983 Jan;39(1):5-21. doi: 10.1016/s0015-0282(16)46750-6.'}, {'pmid': '18485348', 'type': 'BACKGROUND', 'citation': 'Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss. Fertil Steril. 2008 Jun;89(6):1603. doi: 10.1016/j.fertnstert.2008.03.002. Epub 2008 May 16. No abstract available.'}, {'pmid': '30542782', 'type': 'DERIVED', 'citation': 'Yetkinel S, Kilicdag EB, Aytac PC, Haydardedeoglu B, Simsek E, Cok T. Effects of the microfluidic chip technique in sperm selection for intracytoplasmic sperm injection for unexplained infertility: a prospective, randomized controlled trial. J Assist Reprod Genet. 2019 Mar;36(3):403-409. doi: 10.1007/s10815-018-1375-2. Epub 2018 Dec 12.'}], 'seeAlsoLinks': [{'url': 'http://fertilechip.com/en/', 'label': 'fertile chip official site'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles.', 'detailedDescription': 'The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles. On study arm sperm selection will be performed by using special microchannel system which is called fertile chip (FC) without using sperm wash procedure. This FC system leads to select lineer motile progressive sperm selection. In control group, sperm selection will be performed by classical way which sperm will be undertaken to sperm wash by gradient method.\n\nAfter selection of sperm in both arms, ICSI will be performed. The outcomes of ICSI schedule will be assesed by fertilization and clinical pregnancy rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 20-37 year-old women\n* normal tubal patency, normal uterine cavity, normal ovulation,\n* between 20-40 year-old men\n* normal semen analyse by WHO criterias\n* unexplained infertile couples\n\nExclusion Criteria:\n\n* poor ovarian reserve which is diagnosed by Bologna criterias\n* abnormal semen analyse by WHO sperm criterias\n* abnormal ovulation problems,tubal patency or uterine cavity'}, 'identificationModule': {'nctId': 'NCT02488434', 'briefTitle': 'The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'The Effectiveness of Using Fertile Chip on Intracytoplasmic Sperm Injection Undergoing Ivf Programme in Unexplained Infertile Couples', 'orgStudyIdInfo': {'id': 'KA15/132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fertile chip', 'description': 'sperm selection by using fertile chip and conventional methods', 'interventionNames': ['Device: fertile chip']}, {'type': 'NO_INTERVENTION', 'label': 'classical ICSI procedure', 'description': 'unexplained infertile couples who will be undertaken intracytoplasmic sperm injection (ICSI) for fertilisation'}], 'interventions': [{'name': 'fertile chip', 'type': 'DEVICE', 'description': 'a new method for sperm selection on ivf cycles by using microchannel system.', 'armGroupLabels': ['fertile chip']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'state': 'Yüreğir', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University Faculty of Medicine Department of Obstetrics and Gynecology Division of Reproductive and Endocrinology Unit', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Esra Bulgan Kılıçdağ, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Reproductive and Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Baskent University, Adana, Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Doctor', 'investigatorFullName': 'Selçuk Yetkinel', 'investigatorAffiliation': 'Baskent University'}}}}