Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-02-09 @ 11:28 PM
Study NCT ID:
NCT03108157
Status:
COMPLETED
Last Update Posted:
2020-06-23
First Post:
2017-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'endoscratchtrial@gmail.com', 'phone': '0034651879266', 'title': 'Dr. Alexandra Izquierdo, Medical and Scientific Director at ProcreaTec', 'organization': 'ProcreaTec'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization.', 'description': 'All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed.\n\nWe did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.', 'eventGroups': [{'id': 'EG000', 'title': 'GROUP A: Intervention Group', 'description': 'Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.', 'otherNumAtRisk': 161, 'deathsNumAtRisk': 161, 'otherNumAffected': 36, 'seriousNumAtRisk': 161, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GROUP B: no Intervention Group', 'description': 'Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.', 'otherNumAtRisk': 172, 'deathsNumAtRisk': 172, 'otherNumAffected': 47, 'seriousNumAtRisk': 172, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Miscarriage', 'notes': 'Pregnancy loss before 12th week of gestation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 12}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ectopic pregnancy', 'notes': 'Extrauterine evidence of pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vanishing twin', 'notes': 'Second twin arrest before week 12th of gestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Placentation abnormalities', 'notes': 'Alterations in placental development (accretism, percretism...)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intrauterine growth restriction', 'notes': 'Pathological decrease in the growth of the fetus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Preterm delivery threat', 'notes': 'Menace of preterm before the 37th week of gestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Premature membrane rupture', 'notes': 'Rupture of gestational membranes before the 37th week of pregnancy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gestational diabetes', 'notes': 'Presence of a diabetical status in a pregnant woman who was not previously diabetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pre-eclampsia', 'notes': 'Gestational hypertension and proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 6}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gestational cholestasis', 'notes': 'Biliary acid alteration due to gestational status', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abortion', 'notes': 'Voluntary interruption of gestation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Preterm delivery', 'notes': 'Delivery before the 37th week of pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 16}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '2nd twin stillbirth', 'notes': 'Intrauterine death of the 2nd twin before delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive Pregnancy Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GROUP A: Intervention Group', 'description': 'Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}, {'id': 'OG001', 'title': 'GROUP B: no Intervention Group', 'description': 'Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 to 14 days after embryo transfer', 'description': 'Positive test (hcG\\>10 UI/ml)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Clinical Pregnancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GROUP A: Intervention Group', 'description': 'Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.\n\nEndometrial scratch: Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.'}, {'id': 'OG001', 'title': 'GROUP B: no Intervention Group', 'description': 'Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 weeks of pregnancy', 'description': 'Ultrasound confirmation of intrauterine pregnancy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Live Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GROUP A: Intervention Group', 'description': 'Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}, {'id': 'OG001', 'title': 'GROUP B: no Intervention Group', 'description': 'Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pregnancy beyond 24 weeks', 'description': 'Birth after 24 weeks of pregnancy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GROUP A: Intervention Group', 'description': 'Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}, {'id': 'FG001', 'title': 'GROUP B: no Intervention Group', 'description': 'Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Recruitment started on January 2017 and finished in October 2018. All patients were recruited at ProcreaTec Fertility Clinic in Madrid'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GROUP A: Intervention Group', 'description': 'Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}, {'id': 'BG001', 'title': 'GROUP B: Non Intervention Group', 'description': 'Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.29', 'spread': '4.27', 'groupId': 'BG000'}, {'value': '41.50', 'spread': '4.67', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smokers', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.78', 'spread': '3.39', 'groupId': 'BG000'}, {'value': '22.92', 'spread': '3.31', 'groupId': 'BG001'}, {'value': '22.8', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-25', 'size': 277855, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-08T03:52', 'hasProtocol': False}, {'date': '2017-01-12', 'size': 85322, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-30T09:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 352}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-10', 'studyFirstSubmitDate': '2017-04-05', 'resultsFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-14', 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Pregnancy Test', 'timeFrame': '12 to 14 days after embryo transfer', 'description': 'Positive test (hcG\\>10 UI/ml)'}, {'measure': 'Clinical Pregnancy', 'timeFrame': '5 weeks of pregnancy', 'description': 'Ultrasound confirmation of intrauterine pregnancy'}], 'secondaryOutcomes': [{'measure': 'Live Birth', 'timeFrame': 'Pregnancy beyond 24 weeks', 'description': 'Birth after 24 weeks of pregnancy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IVF', 'DONOR EGGS', 'ENDOMETRIAL SCRATCH', 'PIPELLE', 'ONGOING PREGNANCY'], 'conditions': ['EMBRYO IMPLANTATION']}, 'referencesModule': {'references': [{'pmid': '25064410', 'type': 'BACKGROUND', 'citation': 'Dain L, Ojha K, Bider D, Levron J, Zinchenko V, Walster S, Dirnfeld M. Effect of local endometrial injury on pregnancy outcomes in ovum donation cycles. Fertil Steril. 2014 Oct;102(4):1048-54. doi: 10.1016/j.fertnstert.2014.06.044. Epub 2014 Jul 23.'}, {'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': '25803542', 'type': 'BACKGROUND', 'citation': 'Nastri CO, Lensen SF, Gibreel A, Raine-Fenning N, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2015 Mar 22;(3):CD009517. doi: 10.1002/14651858.CD009517.pub3.'}, {'pmid': '25561347', 'type': 'BACKGROUND', 'citation': 'Gibreel A, El-Adawi N, Elgindy E, Al-Inany H, Allakany N, Tournaye H. Endometrial scratching for women with previous IVF failure undergoing IVF treatment. Gynecol Endocrinol. 2015 Apr;31(4):313-6. doi: 10.3109/09513590.2014.994603. Epub 2015 Jan 5.'}, {'pmid': '26950730', 'type': 'BACKGROUND', 'citation': 'Ko JK, Ng EH. Scratching and IVF: any role? Curr Opin Obstet Gynecol. 2016 Jun;28(3):178-83. doi: 10.1097/GCO.0000000000000264.'}, {'pmid': '26752857', 'type': 'BACKGROUND', 'citation': 'Singh N, Toshyan V, Kumar S, Vanamail P, Madhu M. Does endometrial injury enhances implantation in recurrent in-vitro fertilization failures? A prospective randomized control study from tertiary care center. J Hum Reprod Sci. 2015 Oct-Dec;8(4):218-23. doi: 10.4103/0974-1208.170401.'}, {'pmid': '24100512', 'type': 'BACKGROUND', 'citation': 'Wise J. Endometrial scratching improves IVF pregnancy rate. BMJ. 2013 Oct 4;347:f6007. doi: 10.1136/bmj.f6007. No abstract available.'}, {'pmid': '25663163', 'type': 'BACKGROUND', 'citation': 'Yang R, Yang S, Li R, Chen X, Wang H, Ma C, Liu P, Qiao J. Biochemical pregnancy and spontaneous abortion in first IVF cycles are negative predictors for subsequent cycles: an over 10,000 cases cohort study. Arch Gynecol Obstet. 2015 Aug;292(2):453-8. doi: 10.1007/s00404-015-3639-8. Epub 2015 Feb 8.'}, {'pmid': '25644507', 'type': 'BACKGROUND', 'citation': 'Ueno J, Salgado RM, Tomioka RB, Colucci JA, Schor E, Carvalho FM. Clinical relevance of diagnostic hysteroscopy with concurrent endometrial biopsy in the accurate assessment of intrauterine alterations. Arch Gynecol Obstet. 2015 Aug;292(2):363-9. doi: 10.1007/s00404-015-3634-0. Epub 2015 Feb 3.'}, {'pmid': '25473625', 'type': 'BACKGROUND', 'citation': 'Timeva T, Shterev A, Kyurkchiev S. Recurrent implantation failure: the role of the endometrium. J Reprod Infertil. 2014 Oct;15(4):173-83.'}, {'pmid': '25349438', 'type': 'BACKGROUND', 'citation': 'Gnainsky Y, Granot I, Aldo P, Barash A, Or Y, Mor G, Dekel N. Biopsy-induced inflammatory conditions improve endometrial receptivity: the mechanism of action. Reproduction. 2015 Jan;149(1):75-85. doi: 10.1530/REP-14-0395. Epub 2014 Oct 27.'}, {'pmid': '27121007', 'type': 'BACKGROUND', 'citation': 'Lensen S, Martins W, Nastri C, Sadler L, Farquhar C. Pipelle for Pregnancy (PIP): study protocols for three randomised controlled trials. Trials. 2016 Apr 27;17(1):216. doi: 10.1186/s13063-016-1301-9.'}, {'pmid': '27008891', 'type': 'BACKGROUND', 'citation': "Lensen S, Sadler L, Farquhar C. Endometrial scratching for subfertility: everyone's doing it. Hum Reprod. 2016 Jun;31(6):1241-4. doi: 10.1093/humrep/dew053. Epub 2016 Mar 22."}, {'pmid': '20070722', 'type': 'BACKGROUND', 'citation': 'Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.'}, {'pmid': '25316455', 'type': 'BACKGROUND', 'citation': 'Nastri CO, Polanski LT, Raine-Fenning N, Martins WP. Endometrial scratching for women with repeated implantation failure. Hum Reprod. 2014 Dec;29(12):2855-6. doi: 10.1093/humrep/deu257. Epub 2014 Oct 14. No abstract available.'}, {'pmid': '26218557', 'type': 'BACKGROUND', 'citation': 'Panagiotopoulou N, Karavolos S, Choudhary M. Endometrial injury prior to assisted reproductive techniques for recurrent implantation failure: a systematic literature review. Eur J Obstet Gynecol Reprod Biol. 2015 Oct;193:27-33. doi: 10.1016/j.ejogrb.2015.06.026. Epub 2015 Jul 17.'}, {'pmid': '26890618', 'type': 'BACKGROUND', 'citation': 'Kitaya K, Matsubayashi H, Takaya Y, Nishiyama R, Yamaguchi K, Ishikawa T. Clinical background affecting pregnancy outcome following local endometrial injury in infertile patients with repeated implantation failure. Gynecol Endocrinol. 2016 Jul;32(7):587-90. doi: 10.3109/09513590.2016.1144742. Epub 2016 Feb 18.'}, {'pmid': '23754314', 'type': 'BACKGROUND', 'citation': 'Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.'}, {'pmid': '32473654', 'type': 'DERIVED', 'citation': 'Izquierdo A, de la Fuente L, Spies K, Rayward J, Lopez L, Lora D, Galindo A. Endometrial scratch vs no intervention in egg donation cycles: the ENDOSCRATCH trial protocol. BMC Pregnancy Childbirth. 2020 May 30;20(1):333. doi: 10.1186/s12884-020-02958-0.'}, {'pmid': '32468267', 'type': 'DERIVED', 'citation': 'Izquierdo Rodriguez A, de la Fuente Bitaine L, Spies K, Lora D, Galindo A. Endometrial Scratching Effect on Clinical Pregnancy Rates in Patients Undergoing Egg Donor In Vitro Fertilization Cycles: the ENDOSCRATCH Randomized Clinical Trial (NCT03108157). Reprod Sci. 2020 Oct;27(10):1863-1872. doi: 10.1007/s43032-020-00204-8. Epub 2020 May 28.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trial about the effect of endometrial scratch on pregnancy rates in patients undergoing a treatment with in-vitro fertilization with donor eggs, when doing the endometrial biopsy during the cycle prior to the embryo transfer.', 'detailedDescription': 'The aim of this clinical trial is to investigate whether an endometrial scratch during the cycle prior to embryo transfer cycle is effective or not in increasing pregnancy rates. Previous studies about this issue have not shown clear conclusions about the effectiveness of this method.\n\nThe endometrial scratch is a simple technique that consists in performing a mild injury to all the internal walls of the uterus with a Pipelle Cournier.\n\nTo achieve the trial objective, all participating patients are randomly divided into two groups. Once patients decide to participate in the trial, they are assigned to each group according to the randomization list:\n\nGroup A: Patients with transfer of fresh embryos after taking an endometrium biopsy during the previous cycle and then following the conventional preparation protocol.\n\nGroup B: Patients with transfer of fresh embryos with the conventional preparation protocol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female undergoing IVF treatment with donor eggs\n\nExclusion Criteria:\n\n* Severe male factor ( less tan 2 million spermatozoa per ml )\n* Uterine abnormalities'}, 'identificationModule': {'nctId': 'NCT03108157', 'briefTitle': 'Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF', 'organization': {'class': 'OTHER', 'fullName': 'Procreatec'}, 'officialTitle': 'Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF', 'orgStudyIdInfo': {'id': 'ENDOSCRATCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP A: intervention group', 'description': 'Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.', 'interventionNames': ['Procedure: Endometrial scratch']}, {'type': 'NO_INTERVENTION', 'label': 'GROUP B: no intervention group', 'description': 'Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.'}], 'interventions': [{'name': 'Endometrial scratch', 'type': 'PROCEDURE', 'otherNames': ['Scratching'], 'description': 'Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.', 'armGroupLabels': ['GROUP A: intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28036', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Procreatec', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Alberto Galindo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario 12 Octubre'}, {'name': 'Laura De la Fuente, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario 12 Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Procreatec', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'ALEXANDRA IZQUIERDO RODRIGUEZ', 'investigatorAffiliation': 'Procreatec'}}}}