Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-27 @ 10:01 PM
Study NCT ID:
NCT01223092
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-07
First Post:
2010-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Gene Associations and Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood serum, follicular fluid and sperm'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of retrieved oocytes', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Fertilization rate', 'timeFrame': '1 month', 'description': 'Number of oocytes that are fertilized'}, {'measure': 'Number of available embryos', 'timeFrame': '1 month', 'description': 'Number of embryos that are available for transfer on day 3 or day 5'}, {'measure': 'Pregnancy rates', 'timeFrame': '1 year', 'description': 'Clinical pregnancy rates (detection of pregnancy hormone bHCG in blood) and delivery rates.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVF', 'infertility', 'DNA'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '18930193', 'type': 'BACKGROUND', 'citation': 'Patounakis G, Treff N, Tao X, Lonczak A, Scott RT Jr, Frattarelli JL. The p53 codon 72 single nucleotide polymorphism lacks a significant effect on implantation rate in fresh in vitro fertilization cycles: an analysis of 1,056 patients. Fertil Steril. 2009 Oct;92(4):1290-1296. doi: 10.1016/j.fertnstert.2008.07.1783. Epub 2008 Oct 17.'}, {'pmid': '26545911', 'type': 'DERIVED', 'citation': 'Patounakis G, Bergh E, Forman EJ, Tao X, Lonczak A, Franasiak JM, Treff N, Scott RT Jr. Multiple thrombophilic single nucleotide polymorphisms lack a significant effect on outcomes in fresh IVF cycles: an analysis of 1717 patients. J Assist Reprod Genet. 2016 Jan;33(1):67-73. doi: 10.1007/s10815-015-0606-z. Epub 2015 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this this study is to use DNA screening strategies to identify genes and localize genomic regions that are differentially expressed in patients with infertility to further understand the genetic basis for reproductive competence.', 'detailedDescription': 'Experimental strategies seek to discover small variants in DNA sequences, which are associated with certain infertility parameters. The alleles being analyzed in in vitro fertilization (IVF) population are sought to be associated with functional differences in the expression of the gene product that are then mechanistically linked to infertility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing infertility treamtnet', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients undergoing fertility care\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01223092', 'briefTitle': 'Study of Gene Associations and Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'Genes and Gene Polymorphisms Associated With Infertility: Utilization of DNA Characteristics to Better Understand Reproductive Competence', 'orgStudyIdInfo': {'id': 'RMA-00-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undegoing infertility treatment', 'description': 'Male and female patients undergoing infertility treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Reproductive Medicine Associates of New Jersey', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}], 'overallOfficials': [{'name': 'Jason Franasiak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Medicine Associates of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}