Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT01550861
Status:
TERMINATED
Last Update Posted:
2023-11-18
First Post:
2012-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vitro Maturation (IVM) of Human Oocytes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059471', 'term': 'In Vitro Oocyte Maturation Techniques'}], 'ancestors': [{'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2012-02-16', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of oocytes retrieved and embryos generated', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'live birth rate', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infertility', 'in vitro maturation (IVM)', 'in vitro fertilization (IVF)', 'natural cycle'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ivf.org', 'label': 'Center for Reproductive Medicine- Weill Cornell Medical College'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.', 'detailedDescription': 'Collection of one mature egg from a follicle in the ovary without gonadotropin medications (natural cycle IVF) results in low pregnancy rates. One way to improve natural cycle IVF is to combine this procedure with the removal of immature eggs from the ovary and mature these eggs in the laboratory ( in vitro maturation-IVM). The in vitro mature eggs are fertilized and the resultant embryos are cultured using conventional IVF techniques.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Each subject must be female.\n2. Each subject must have an indication for COH and IVF with or without ICSI.\n3. Each subject must be willing and able to provide written informed consent for the trial\n4. Each subject must be 25 to ≤42 years of age at the time of signing informed consent.\n5. Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou \\[PAP\\] I or II) obtained within 12 months prior to signing informed consent must be available\n\nExclusion Criteria:\n\n1. Subject with premature ovarian failure\n2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction\n3. Subject with malformation or absence of uterus\n4. Subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).\n5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone'}, 'identificationModule': {'nctId': 'NCT01550861', 'acronym': 'IVM', 'briefTitle': 'In Vitro Maturation (IVM) of Human Oocytes', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'In Vitro Maturation (IVM) of Human Oocytes', 'orgStudyIdInfo': {'id': '1201012117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In vitro Maturation', 'description': 'in vitro maturation of immature oocytes', 'interventionNames': ['Procedure: in vitro maturation', 'Procedure: Polar Body Biopsy with preimplantation genetic screening']}], 'interventions': [{'name': 'in vitro maturation', 'type': 'PROCEDURE', 'description': 'Maturation of immature oocytes in the laboratory following oocyte retrieval', 'armGroupLabels': ['In vitro Maturation']}, {'name': 'Polar Body Biopsy with preimplantation genetic screening', 'type': 'PROCEDURE', 'description': 'Polar body biopsy is performed on the day that the oocyte is retrieved. Microarray analysis will will be performed and compared with FISH and microarray analysis of day 3 or day 5 biopsy.', 'armGroupLabels': ['In vitro Maturation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Reproductive Medicine- Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Zev Rosenwaks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Cornell'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}