Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT01030393
Status:
COMPLETED
Last Update Posted:
2012-08-21
First Post:
2009-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
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': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 472}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-18', 'studyFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implantation and pregnancy rates', 'timeFrame': '5 weeks after embryo transfer'}], 'secondaryOutcomes': [{'measure': 'miscarriage and delivery rates', 'timeFrame': '9 months from embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hCG', 'pregnancy', 'implantation', 'ICSI', 'IVF'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '19380797', 'type': 'BACKGROUND', 'citation': 'Schumacher A, Brachwitz N, Sohr S, Engeland K, Langwisch S, Dolaptchieva M, Alexander T, Taran A, Malfertheiner SF, Costa SD, Zimmermann G, Nitschke C, Volk HD, Alexander H, Gunzer M, Zenclussen AC. Human chorionic gonadotropin attracts regulatory T cells into the fetal-maternal interface during early human pregnancy. J Immunol. 2009 May 1;182(9):5488-97. doi: 10.4049/jimmunol.0803177.'}, {'pmid': '22047664', 'type': 'DERIVED', 'citation': 'Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will attract regulatory T cells and improve implantation.', 'detailedDescription': 'Background :\n\nHuman chorionic gonadotrophin ( hCG) was found to secreted immediately after fertilization by the embryo. It plays an important role in implantation and in attracting regulatory T cells to the endometrium.\n\nRational :\n\nIntrauterine injection of hCG before embryo transfer in IVF/ICSI may increase endometrial regulatory T cells ( Treg ) and improve the implantation and pregnancy rates.\n\nAim of the work :\n\nTo study the effect of intrauterine injection of hCG before embryo transfer on the implantation and pregnancy rates after IVF/ICSI.\n\nSubjects :\n\nInfertile patients undergoing ICSI.\n\nInclusion criteria :\n\n* Female age less than 40 years\n* Male factor infertility\n* Normal female hormonal profile and uterine cavity\n\nExclusion criteria :\n\n* Previous ICSI failure\n* Azoospermia\n* Endometriosis\n\nStudy group: Intrauterine injection of 100 iu of hCG (group 1)or 200 iu of hCG ( group 2) will be done during the dummy embryo transfer which is done 10-15 minutes before the actual embryo transfer.\n\nControl group: The embryo transfer will be done without prior intrauterine injection of hCG\n\nMain outcome measures :\n\nImplantation and pregnancy rates\n\nSecondary outcome measures :\n\nmiscarriage and delivery rates'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male factor infertility\n* normal female hormonal profile\n* normal uterine cavity\n\nExclusion Criteria:\n\n* previous ICSI failure\n* endometriosis\n* azoospermia'}, 'identificationModule': {'nctId': 'NCT01030393', 'briefTitle': 'Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'The Egyptian IVF-ET Center'}, 'officialTitle': 'Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI', 'orgStudyIdInfo': {'id': 'hCG 100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intrauterine hCG', 'description': 'Experimental arm : intrauterine injection of 100 iu(group1)or 200 iu (group2) of hCG before embryo transfer.\n\nIntrauterine injection of 500 iu hCG before embryo transfer', 'interventionNames': ['Drug: human chorionic gonadotrophin']}], 'interventions': [{'name': 'human chorionic gonadotrophin', 'type': 'DRUG', 'otherNames': ['choriomon'], 'description': 'intrauterine injection of 100 iu (group1) or 200 iu (group2) of hCG before embryo transfer in IVF/ICSI And intrauterine injection of 500 iu hCG before embryo transfer .', 'armGroupLabels': ['intrauterine hCG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11431', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'The Egyptian IVF- ET center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ragaa T Mansour, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Egyptian IVF-ET Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Egyptian IVF-ET Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ragaa Mansour', 'investigatorAffiliation': 'The Egyptian IVF-ET Center'}}}}