Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-04 @ 7:22 AM
Study NCT ID:
NCT02250768
Status:
COMPLETED
Last Update Posted:
2014-09-26
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Embryogen in RIF Patients
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': 'D016178', 'term': 'Granulocyte-Macrophage Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-23', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ongoing pregnancy rate', 'timeFrame': '12 week of gestation'}], 'secondaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '7 week of gestation'}, {'measure': 'clinical pregnancy rate', 'timeFrame': '7 week of gestation'}, {'measure': 'top quality embryo rate', 'timeFrame': '44 hours after insemination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GM-CSF, repeated implantation failure'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)', 'detailedDescription': '60 patients with repeated implantation failure were involved.\n\nRIF was defined as patients failed to conceive (beta-hCG \\< 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more.\n\nOvarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at fixed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval.\n\nLuteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal ovarian reserve (AMH \\> 1.1 ng/ml)\n* Regular menstrual cycle (25 - 34 days)\n* Clear informations about at least 3 latest IVF/ET\n* Fresh embryo transfer in this cycle\n* Endometrial thickness of 10 mm or more\n\nExclusion Criteria:\n\n* Undergo oocyte donation or in vitro maturation (IVM) cycles\n* Using frozen or surgically retrieved sperm\n* Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges\n* In participation in other studies/interventions'}, 'identificationModule': {'nctId': 'NCT02250768', 'acronym': 'RIF', 'briefTitle': 'Effects of Embryogen in RIF Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vietnam National University'}, 'officialTitle': 'Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure', 'orgStudyIdInfo': {'id': 'CGRH-Embryogen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GM-CSF', 'description': 'Injected oocytes were cultured in GM-CSF supplemented media until day of transfer', 'interventionNames': ['Biological: GM-CSF']}], 'interventions': [{'name': 'GM-CSF', 'type': 'BIOLOGICAL', 'description': '2ng/ml of GM-CSF supplemented into culture media', 'armGroupLabels': ['GM-CSF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ho Chi Minh City', 'state': 'Ho Chi Minh', 'country': 'Vietnam', 'facility': 'An Sinh Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'An Sinh Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Vinh Q Dang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Genetics and Reproductive Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vietnam National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dang Quang Vinh', 'investigatorAffiliation': 'Vietnam National University'}}}}