Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-24 @ 12:06 PM
Study NCT ID:
NCT01472861
Status:
TERMINATED
Last Update Posted:
2015-06-12
First Post:
2011-11-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autologous Endometrial Coculture (AECCT)
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-10', 'studyFirstSubmitDate': '2011-11-11', 'studyFirstSubmitQcDate': '2011-11-16', 'lastUpdatePostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy outcome', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Embryo quality', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coculture', 'endometrial biopsy', 'IVF poor responders'], 'conditions': ['Infertility']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ivf.org', 'label': 'Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the use of Autologous Endometrial Coculture (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves pregnancy outcome.', 'detailedDescription': "Young women with poor ovarian reserve are commonly given a poor prognosis for IVF success. Standard culture media for fertilizing oocytes (unfertilized eggs) is commonly used in IVF which closely resembles tubal fluid. Efforts to create optimal culture conditions for fertilization of human embryos for women with poor quality embryos and/or repeated implantation failures have been developed at our center by using AECC. AECC involves placing a patient's fertilized eggs on top of a layer of cells from her own uterine lining, creating a more natural environment for embryo development and maximizing the chance for IVF pregnancy. The investigators will prospectively randomize young patients (≤ age 38 years) poor ovarian reserve to AECC or no AECC with standard culture media to study pregnancy outcome."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy women undergoing IVF at CRMI\n* Age ≤ 38 years\n* Poor ovarian reserve with antral follicle count less than 6 follicles, cycle day 2/3 FSH \\> 12 ng/ml, AMH \\< 0.5 ng/ml\n\nExclusion Criteria:\n\n* Healthy women undergoing IVF with male factor, severe endometriosis, or tubal factor infertility\n* Donor patients\n* Contraindications for the use of gonadotropins (i.e. pregnancy, lactation, undiagnosed vaginal bleeding or ovarian cysts)\n* Recent or current medical conditions where the patient is not medically stable to undergo stimulation or egg retrieval, HIV infection, diabetes, cardiovascular disease, gastrointestinal, hepatic disease, renal or pulmonary disease.\n* Any patient who is not a candidate for IVF'}, 'identificationModule': {'nctId': 'NCT01472861', 'acronym': 'AECCT', 'briefTitle': 'Autologous Endometrial Coculture (AECCT)', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve', 'orgStudyIdInfo': {'id': '0903010293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'No AECC', 'description': 'Routine procedures without AECC', 'interventionNames': ['Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed']}, {'type': 'EXPERIMENTAL', 'label': 'AECC', 'description': 'Endometrial biopsy and Autologous endometrial coculture', 'interventionNames': ['Procedure: AECC (Autologous endometrial coculture)']}], 'interventions': [{'name': 'AECC (Autologous endometrial coculture)', 'type': 'PROCEDURE', 'description': 'endometrial biopsy with autologous endometrial coculture', 'armGroupLabels': ['AECC']}, {'name': 'no endometrial biopsy or Autologous endometrial coculture (AECC) performed', 'type': 'OTHER', 'description': 'routine procedures with out biopsy', 'armGroupLabels': ['No AECC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Reproducutve Medicine; Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Spandorfer Steven, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}