Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-10 @ 6:19 PM
Study NCT ID:
NCT02180256
Status:
TERMINATED
Last Update Posted:
2018-05-14
First Post:
2014-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'whyStopped': 'The main investigators are no longer working at the the center', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2014-06-30', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '8 weeks', 'description': 'The number of gestational sacs divided by the number of transferred embryos in each arm. This outcome will be assessed by examining the medical records.'}], 'primaryOutcomes': [{'measure': 'Live birth', 'timeFrame': '1 year', 'description': 'The number of participants who delivered a living baby in each arm. The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact.'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy', 'timeFrame': '8 weeks', 'description': 'The number of participants achieved clinical pregnancy detected by ultrasound (either intrauterine or ectopic). The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact.'}, {'measure': 'Miscarriage', 'timeFrame': '20 weeks', 'description': 'The number of participants who experienced spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age. The denominator will be the number of women who achieved clinical pregnancy in each arm. This outcome will be assessed by examining the medical records and telephone contact.'}, {'measure': 'Multiple pregnancy', 'timeFrame': '8 weeks', 'description': 'The number of pregnant participants with more than one gestational sac (twins/triplets). The denominator will be the number of women who achieved clinical pregnancy in each arm. This outcome will be assessed by examining the medical records and telephone contact.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IVF', 'ICSI', 'Embryo transfer', 'Assisted reproduction', 'Endometrial injury', 'Endometrial scratching'], 'conditions': ['Subfertility']}, 'referencesModule': {'references': [{'pmid': '24835342', 'type': 'BACKGROUND', 'citation': 'Nastri CO, Teixeira DM, Ferriani RA, Martins WP. The overlooked endometrial injury underlying hysteroscopy procedures. Reprod Biomed Online. 2014 Jul;29(1):140. doi: 10.1016/j.rbmo.2014.03.021. Epub 2014 Apr 28. No abstract available.'}, {'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': '23339704', 'type': 'BACKGROUND', 'citation': 'Nastri CO, Teixeira DM, Martins WP. Endometrial injury in the menstrual cycle prior to assisted reproduction techniques to improve reproductive outcomes. Gynecol Endocrinol. 2013 May;29(5):401-2. doi: 10.3109/09513590.2012.760193. Epub 2013 Jan 22. No abstract available.'}, {'pmid': '22786529', 'type': 'BACKGROUND', 'citation': 'Nastri CO, Gibreel A, Raine-Fenning N, Maheshwari A, Ferriani RA, Bhattacharya S, Martins WP. Endometrial injury in women undergoing assisted reproductive techniques. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009517. doi: 10.1002/14651858.CD009517.pub2.'}]}, 'descriptionModule': {'briefSummary': 'To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler, performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates in women who will be submitted to a fresh embryo transfer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* First four days of the menstrual cycle, just before starting controlled ovarian stimulation for planned IVF and fresh embryo transfer.\n* Not have performed endometrial scratching in the last 90 days.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02180256', 'briefTitle': 'Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'orgStudyIdInfo': {'id': 'CAAE: 30504514.6.0000.5440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoscratching, non-RIF', 'description': 'Endometrial scratching. Women with no more than 1 previous unsuccessful embryo transfer. Pipelle in the first seven days of the menstrual cycle, just before starting controlled ovarian stimulation.', 'interventionNames': ['Procedure: Endometrial Scratching']}, {'type': 'NO_INTERVENTION', 'label': 'Control, non-RIF', 'description': 'No intervention. Women with no more than 1 previous unsuccessful embryo transfer.'}, {'type': 'EXPERIMENTAL', 'label': 'Endoscratching, RIF', 'description': 'Endometrial scratching. Women with 2 or more previous unsuccessful embryo transfers. Pipelle in the first seven days of the menstrual cycle, just before starting controlled ovarian stimulation.', 'interventionNames': ['Procedure: Endometrial Scratching']}, {'type': 'NO_INTERVENTION', 'label': 'Control, RIF', 'description': 'No intervention. Women with 2 or more previous unsuccessful embryo transfers.'}], 'interventions': [{'name': 'Endometrial Scratching', 'type': 'PROCEDURE', 'otherNames': ['Endometrial injury', 'Endometrial biopsy', 'Endoscratching'], 'description': 'The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.', 'armGroupLabels': ['Endoscratching, RIF', 'Endoscratching, non-RIF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hc-Fmrp-Usp', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Wellington P Martins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Wellington P Martins, MD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}