Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-04-17 @ 8:00 PM
Study NCT ID:
NCT03174951
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2017-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2017-05-28', 'studyFirstSubmitQcDate': '2017-05-31', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in NK cells, T reg and Th17 cells frequency.', 'timeFrame': 'up to 8 month of pregnancy', 'description': 'Flowcytometry'}, {'measure': 'Changes in secretion levels of cytokines related to Treg and Th17 cells(IL-17,IL-21)', 'timeFrame': 'up to 8 month of pregnancy', 'description': 'Elisa'}, {'measure': 'Changes in exoression of cytokines gene.', 'timeFrame': 'up to 8 month of pregnancy', 'description': 'RT pcr'}], 'secondaryOutcomes': [{'measure': 'Ongoing pregnancy rate in patients with Recurrent Pregnancy Loss (RPL)', 'timeFrame': 'up to 8 month of pregnancy', 'description': 'by sonography'}, {'measure': 'Live berth rate in patients with Recurrent Pregnancy Loss (RPL).', 'timeFrame': 'up to 1 year', 'description': 'Monitoring by gynecologists'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recurrent Pregnancy Loss', 'IVIg', 'Pregnancy Rate'], 'conditions': ['Recurrent Pregnancy Loss']}, 'referencesModule': {'references': [{'pmid': '22889462', 'type': 'RESULT', 'citation': 'Sugiura-Ogasawara M, Suzuki S, Ozaki Y, Katano K, Suzumori N, Kitaori T. Frequency of recurrent spontaneous abortion and its influence on further marital relationship and illness: the Okazaki Cohort Study in Japan. J Obstet Gynaecol Res. 2013 Jan;39(1):126-31. doi: 10.1111/j.1447-0756.2012.01973.x. Epub 2012 Aug 13.'}, {'pmid': '19710204', 'type': 'RESULT', 'citation': 'Santos MA, Kuijk EW, Macklon NS. The impact of ovarian stimulation for IVF on the developing embryo. Reproduction. 2010 Jan;139(1):23-34. doi: 10.1530/REP-09-0187.'}, {'pmid': '19819893', 'type': 'RESULT', 'citation': 'King K, Smith S, Chapman M, Sacks G. Detailed analysis of peripheral blood natural killer (NK) cells in women with recurrent miscarriage. Hum Reprod. 2010 Jan;25(1):52-8. doi: 10.1093/humrep/dep349. Epub 2009 Oct 9.'}, {'pmid': '24628478', 'type': 'RESULT', 'citation': "Goring SM, Levy AR, Ghement I, Kalsekar A, Eyawo O, L'Italien GJ, Kasiske B. A network meta-analysis of the efficacy of belatacept, cyclosporine and tacrolimus for immunosuppression therapy in adult renal transplant recipients. Curr Med Res Opin. 2014 Aug;30(8):1473-87. doi: 10.1185/03007995.2014.898140. Epub 2014 Apr 3."}, {'pmid': '12765346', 'type': 'RESULT', 'citation': 'Yamada H, Morikawa M, Furuta I, Kato EH, Shimada S, Iwabuchi K, Minakami H. Intravenous immunoglobulin treatment in women with recurrent abortions: increased cytokine levels and reduced Th1/Th2 lymphocyte ratio in peripheral blood. Am J Reprod Immunol. 2003 Feb;49(2):84-9. doi: 10.1034/j.1600-0897.2003.01184.x.'}, {'pmid': '17166218', 'type': 'RESULT', 'citation': 'Hutton B, Sharma R, Fergusson D, Tinmouth A, Hebert P, Jamieson J, Walker M. Use of intravenous immunoglobulin for treatment of recurrent miscarriage: a systematic review. BJOG. 2007 Feb;114(2):134-42. doi: 10.1111/j.1471-0528.2006.01201.x. Epub 2006 Dec 12.'}, {'pmid': '21095154', 'type': 'RESULT', 'citation': 'Kolls JK, Khader SA. The role of Th17 cytokines in primary mucosal immunity. Cytokine Growth Factor Rev. 2010 Dec;21(6):443-8. doi: 10.1016/j.cytogfr.2010.11.002. Epub 2010 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'Miscarriage occurs in about 1-2% of human pregnancies and is one of the common pregnancy problems before 12 weeks of pregnancy. Anatomical and chromosomal abnormalities, microbial factors and auto and alloimmune reactions have been speculated to attribute in recurrent miscarriage. Unexplained recurrent miscarriage (URM) is defined as three or more repeated abortions, probably caused by maternal immunological rejection . Given that maternal immune system encounters semi-allogeneic fetus, pregnancy outcome is associated with the interaction between maternal immune system and immuno-regulatory capability of the fetus. Effectiveness of treatment approaches in RM patients has been controversial and remained to be discovered. Immunomodulatory agents such as corticosteroids and allogeneic lymphocyte immunization showed variable success rates in RM patients. Therapeutic effects of IVIG in unexplained RM is controversial and most positive results were obtained from the trials in RM women with cellular immune abnormalities, such as increased NK cell level and/or cytotoxicity, and T cell abnormalities. Previous studies have shown that the incidence of genetic abnormalities in children who have received immunosuppressive drugs such as IVIg like normal people and normal society. In this study we used IVIg at the time of positive pregnancy,400 mg/kg IVIG was administered intravenously. Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation to suppress the immune system in patients with immunological causes of RPL and the results will be compared with a control group that did not receive any type of drug.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled patients will experience at least 3 times recurrent pregnancy loss.\n* Patients dont have history of any type of immunotherapy.\n* Patients must have abnormal NK cell or NK cell cytotoxicity or Th1/Th2 ratio\n\nExclusion Criteria:\n\n\\- Our criteria for exclusion of patients from the study include the following:\n\n* Patients or their spouse has abnormal karyotype or chromosomal and genetically disorders.\n* Patients who have bleeding problems.\n* Patients who have chronic disorders those are forced to use the specific drug.\n* Patients who have positive test for HIV, HCV or HBV infection.\n* Patients who have a history of asthma and allergies.\n* Patients who have uterus abnormalities.'}, 'identificationModule': {'nctId': 'NCT03174951', 'briefTitle': 'Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss', 'organization': {'class': 'OTHER', 'fullName': 'Tabriz University of Medical Sciences'}, 'officialTitle': 'Effect of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss With Immunological Causes', 'orgStudyIdInfo': {'id': 'TabrizUMS-infertility-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'IVIg group', 'interventionNames': ['Drug: IVIg']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Patients who do not receive any treatment despite a history of Recurrent Pregnancy Loss problem as controls'}], 'interventions': [{'name': 'IVIg', 'type': 'DRUG', 'description': 'Patients will take 400mg/kg IVIg at the time of positive pregnancy,Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tabriz', 'country': 'Iran', 'facility': 'Alzahra hospital', 'geoPoint': {'lat': 38.08, 'lon': 46.2919}}], 'overallOfficials': [{'name': 'Mohammad Nouri, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of SCARM institute'}, {'name': 'Mehdi Yousefi, Immunologist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SCARM institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tabriz University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}