Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-28 @ 11:32 PM
Study NCT ID:
NCT01219335
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2010-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discarded Materials Study
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': 'Discarded non-viable oocytes, granulosa cells, spermatozoa, developmentally arrested embryos, serum, follicular fluid, and conditioned IVF media.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Methods for freezing -embryos', 'timeFrame': 'duration of the study', 'description': 'To test, standardize and implement better methods for the freezing embryos prior to these techniques being used in the clinical setting'}], 'secondaryOutcomes': [{'measure': 'Development non-invasive tests', 'timeFrame': 'duration of the study', 'description': 'To develop non-invasive tests for predicting embryo quality as well as IVF success'}, {'measure': 'Factors that control embryo development', 'timeFrame': 'duration of the study', 'description': 'To analyze embryos to learn more about what controls their early development and function.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVF'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Use of discarded embryos to advance laboratory expertise and technology in the area of human embryo development and assisted reproductive technologies', 'detailedDescription': '1- Testing methods or freezing before implementing techniques. 2- Develop cell surgery and micromanipulation techniques. 3- Develop methods to optimize the determinations of genes and chromosomes 4- Quality-assess laboratory equipment. 5- Test proficiency of laboratory staff. 6- Analyze what effects the early development of embryos. 7- Develop new methods and media to allow for higher survival rates of embryos. 8- Develop non-invasive tests for predicting embryo quality to predict IVF success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing infertility treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nnone\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT01219335', 'briefTitle': 'Discarded Materials Study', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'Laboratory Evaluation of De-identified, Developmentally Arrested Embryos of Embryos Diagnosed as Having an Abnormal Number of Chromosomes for Optimization of Techniques for Assisted Reproduction', 'orgStudyIdInfo': {'id': 'RMA-00-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine V Reda, BSN, RN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@rmanj.com', 'phone': '973-656-2841'}, {'name': 'Caroline Zuckerman, RN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@rmanj.com', 'phone': '973-656-2841'}, {'name': 'Thomas Molinaro, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reproductive Medicine Associates of new Jersey', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}], 'centralContacts': [{'name': 'Christine V Whitehead, BSN, RN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@rmanj.com', 'phone': '973-656-2841'}, {'name': 'Caroline Zuckerman, RN', 'role': 'CONTACT', 'email': 'clinicalresearchteam@rmanj.com', 'phone': '973-656-2841'}], 'overallOfficials': [{'name': 'Thomas Molinaro, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Medicine Associates of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}