Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-08 @ 3:44 AM
Study NCT ID:
NCT02306395
Status:
UNKNOWN
Last Update Posted:
2016-01-05
First Post:
2014-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Local Injury to Improve the Outcome of Embryo Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2014-11-22', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implantation rate', 'timeFrame': '3 months after intervention', 'description': 'When serum HCG is continuously more than 100mIU/ml and gestational sac is detected by ultrasound,it is considered as implantation.'}], 'secondaryOutcomes': [{'measure': 'the change of three-dimensional ultrasound of uterine cavity before and after intervention', 'timeFrame': 'in implantation window period(12-14 days)', 'description': 'including endometrial thickness, echo, blood flow and uterine cavity volume, uterine vascularization index, flow index.'}, {'measure': 'clinical pregnancy rate', 'timeFrame': 'an expected average of 7 week after pregnancy', 'description': 'The standards is to detect fetal heart beat by ultrasound.'}, {'measure': 'live birth rate', 'timeFrame': 'follow-up for one year after pregnancy', 'description': 'The statistical ratio of live birth rate in two groups'}, {'measure': 'the rate of birth defects', 'timeFrame': 'follow-up for one year after pregnancy', 'description': 'calculate the rate of birth defects in two groups'}, {'measure': 'the expression changes of endometrial inflammatory factors', 'timeFrame': 'endometrial sampling after local injury ,in the first 3-5 days after menstrual period', 'description': 'Detection of inflammatory factors, such as LIF,MIP-1.\n\n\\---------------------------'}, {'measure': 'infection rate', 'timeFrame': 'one week after intervention', 'description': 'detection of infection by serum test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['endometrial local injury', 'repeated implatation failure', 'embyo transfer'], 'conditions': ['Female Infertility Due to Nonimplantation of Ovum']}, 'referencesModule': {'references': [{'pmid': '22885017', 'type': 'BACKGROUND', 'citation': 'El-Toukhy T, Sunkara S, Khalaf Y. Local endometrial injury and IVF outcome: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Oct;25(4):345-54. doi: 10.1016/j.rbmo.2012.06.012. Epub 2012 Jun 26.'}, {'pmid': '23063812', 'type': 'BACKGROUND', 'citation': 'Potdar N, Gelbaya T, Nardo LG. Endometrial injury to overcome recurrent embryo implantation failure: a systematic review and meta-analysis. Reprod Biomed Online. 2012 Dec;25(6):561-71. doi: 10.1016/j.rbmo.2012.08.005. Epub 2012 Sep 12.'}, {'pmid': '17681303', 'type': 'BACKGROUND', 'citation': 'Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.'}, {'pmid': '5050152', 'type': 'RESULT', 'citation': 'Finn CA, Martin L. Endocrine control of the timing of endometrial sensitivity to a decidual stimulus. Biol Reprod. 1972 Aug;7(1):82-6. doi: 10.1093/biolreprod/7.1.82. No abstract available.'}, {'pmid': '20607003', 'type': 'RESULT', 'citation': 'Narvekar SA, Gupta N, Shetty N, Kottur A, Srinivas M, Rao KA. Does local endometrial injury in the nontransfer cycle improve the IVF-ET outcome in the subsequent cycle in patients with previous unsuccessful IVF? A randomized controlled pilot study. J Hum Reprod Sci. 2010 Jan;3(1):15-9. doi: 10.4103/0974-1208.63116.'}, {'pmid': '12798877', 'type': 'RESULT', 'citation': 'Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.'}, {'pmid': '19568761', 'type': 'RESULT', 'citation': 'Karimzade MA, Oskouian H, Ahmadi S, Oskouian L. Local injury to the endometrium on the day of oocyte retrieval has a negative impact on implantation in assisted reproductive cycles: a randomized controlled trial. Arch Gynecol Obstet. 2010 Mar;281(3):499-503. doi: 10.1007/s00404-009-1166-1. Epub 2009 Jul 1.'}, {'pmid': '22943664', 'type': 'RESULT', 'citation': 'Baum M, Yerushalmi GM, Maman E, Kedem A, Machtinger R, Hourvitz A, Dor J. Does local injury to the endometrium before IVF cycle really affect treatment outcome? Results of a randomized placebo controlled trial. Gynecol Endocrinol. 2012 Dec;28(12):933-6. doi: 10.3109/09513590.2011.650750. Epub 2012 Sep 3.'}, {'pmid': '24639710', 'type': 'RESULT', 'citation': 'Parsanezhad ME, Dadras N, Maharlouei N, Neghahban L, Keramati P, Amini M. Pregnancy rate after endometrial injury in couples with unexplained infertility: A randomized clinical trial. Iran J Reprod Med. 2013 Nov;11(11):869-74.'}, {'pmid': '20338560', 'type': 'RESULT', 'citation': 'Gnainsky Y, Granot I, Aldo PB, Barash A, Or Y, Schechtman E, Mor G, Dekel N. Local injury of the endometrium induces an inflammatory response that promotes successful implantation. Fertil Steril. 2010 Nov;94(6):2030-6. doi: 10.1016/j.fertnstert.2010.02.022. Epub 2010 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether edometrial local injury improves the outcome of embryo transfer,and to find out more evidence about the time of trauma,the way of intervention,and the possible mechanism.', 'detailedDescription': 'It is important to evaluate the efficacy of endometrial local injury in assisted reproductive technology(ART),especially on the patients of recurrent implantation failure. Although most trials proved the effectiveness of the intervention of local injury, the subjects of these trials are rarely the patients of repeated implantation failure(RIF). Moreover, the mechanism of endometrial injury is not clear.Our trial may provide further basis for this purpose by comparing to the quality of endometrium in two-dimensional ultrasound.If the technique demonstrates efficacy, it would help the patients with RIF caused by poor conditions of endometrium to deal with the problem of infertility.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with RIF(≥2) of embyo transfer and uneven echo of endometrium on HCG day(12-14 days)\n* Without operation history of uterine cavity in the previous three months\n* Who agree to join in the study\n\nExclusion Criteria:\n\n* Women more than 40 years or less than 20 years\n* With infectious diseases or endocrine diseases\n* Who refuse to participate in the experiment'}, 'identificationModule': {'nctId': 'NCT02306395', 'briefTitle': 'Endometrial Local Injury to Improve the Outcome of Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Navy General Hospital, Beijing'}, 'officialTitle': 'Endometrial Local Injury of Frozen Cycle to Improve the Outcome of Embryo Transfer of Repeated Implantation Failure.', 'orgStudyIdInfo': {'id': 'LY-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endometrial local injury', 'description': 'Endometrial local injury is carried in the first 3-5 days after menstrual period at the same time of hysteroscopy.', 'interventionNames': ['Procedure: Endometrial local injury']}, {'type': 'NO_INTERVENTION', 'label': 'The blank group', 'description': 'Any processing does not carry on the endometrium in the first 3-5 days after menstrual period except hysteroscopy.'}], 'interventions': [{'name': 'Endometrial local injury', 'type': 'PROCEDURE', 'description': 'The way of intervention is to scratch the uterine cavity two cycles by a small spatula in the first 3-5 days after menstrual period.', 'armGroupLabels': ['Endometrial local injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100048', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunhai Chuai, Dr', 'role': 'CONTACT', 'email': 'wangyh85@foxmail.com', 'phone': '+8618810892004'}, {'name': 'Aiming Wang, Dr', 'role': 'CONTACT', 'email': 'one_army@sina.com', 'phone': '+8618600310258'}], 'facility': 'Department of Obstetrics and Gynecology, Navy General Hospital.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yi Li', 'role': 'CONTACT', 'email': '51261886@qq.com', 'phone': '+8613548550909'}], 'overallOfficials': [{'name': 'Aiming Wang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Navy General Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Obstetrics and Gynecology, Navy General Hospital, Beijing', 'investigatorFullName': 'Yunhai Chuai', 'investigatorAffiliation': 'Navy General Hospital, Beijing'}}}}