Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-01 @ 6:39 AM
Study NCT ID:
NCT00367367
Status:
UNKNOWN
Last Update Posted:
2006-08-22
First Post:
2006-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Curettage 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': 'D015907', 'term': 'Hysteroscopy'}, {'id': 'D003475', 'term': 'Curettage'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'lastUpdateSubmitDate': '2006-08-20', 'studyFirstSubmitDate': '2006-08-20', 'studyFirstSubmitQcDate': '2006-08-20', 'lastUpdatePostDateStruct': {'date': '2006-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation rate'}, {'measure': 'Pregnancy rate'}, {'measure': 'Endometrial receptivity'}]}, 'conditionsModule': {'keywords': ['embryo transfer', 'hysteroscopy', 'curettage', 'iv-vitro fertilization', 'molecular markers', 'endometrial receptivity', 'endometrial dating'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '9696242', 'type': 'RESULT', 'citation': 'La Sala GB, Montanari R, Dessanti L, Cigarini C, Sartori F. The role of diagnostic hysteroscopy and endometrial biopsy in assisted reproductive technologies. Fertil Steril. 1998 Aug;70(2):378-80. doi: 10.1016/s0015-0282(98)00147-2.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'Studies have shown that endometrial sampling in the month prior to embryo transfer may increase pregnancy rates. We wish to test this hypothesis by performing a hysteroscopy and curettage in the month proceeding embryo transfer during IVF, IVF/ICSI or Frozen/Thawed cycles.', 'detailedDescription': "It has been suggested that local injury to the endometrium doubles the rate of implantation and successful pregnancies in IVF patients.\n\nPurpose\n\n1. To determine whether performing curettage the month prior to embryo transfer (ET) increases the chance of embryo implantation.\n2. To study molecular attributes of the endometrium taken at curettage and to compare them to those cycles resulting in pregnancy and those which do not result in pregnancy.\n\nSamples will be grown as primary culture in the research laboratory and possible molecular markers and attachment assays for endometrial receptivity will be studied.\n\nPatient selection: Patients undergoing IVF or IVF-ICSI at Ha'Emek medical center/ IVF unit. Woman over 35 years of age will be excluded since implantation failure is more likely to be due to genetic, chromosomal or cytoplasmic aberrations in their oocytes.\n\nProposed protocol:\n\n1. Informed consent obtained from prospective candidates.\n2. Participants randomly divided to three groups\n\n 1. Control group\n 2. Hysteroscopy and curettage performed on days 15-17 of menstrual cycle\n 3. Hysteroscopy and curettage performed on days 19-22 of menstrual cycle\n3. After the following menses an IVF, IVF-ICSI, or frozen embryo cycle is performed according to the unit's standard protocols.\n4. The primary end point of the study will be the implantation rate after ET and the expression of possible molecular markers for endometrial receptivity in the pregnant patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* In-vitro fertilization candidate\n* Normal blood coagulation\n\nExclusion Criteria:\n\n* Anemia (hemoglobin under 10 mg/dl)\n* Abnormal maternal karyotype\n* Thrombocytopenia under 140,000\n* Any contraindication to hysteroscopy or in-vitro fertilization'}, 'identificationModule': {'nctId': 'NCT00367367', 'briefTitle': 'Endometrial Curettage Before Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Endometrial Hysteroscopy and Curettage Prior to Embryo Transfer', 'orgStudyIdInfo': {'id': '3280105'}, 'secondaryIdInfos': [{'id': 'Ministry of Heath:920050038'}, {'id': 'Genetics committee: 2005-061'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Hysteroscopy and Curettage', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Joel Geslevich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amir Weiss, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shabtai Romano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shlomit Goldman, DSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eliezer Shalev, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Obstetrics and gynecology, HaEmek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'centralContacts': [{'name': 'Amir Weiss, MD', 'role': 'CONTACT', 'email': 'weiss_am@clalit.org.il', 'phone': '972-4-6494031'}, {'name': 'Joel Geslevich, MD', 'role': 'CONTACT', 'email': 'yoel_g@clalit.org.il', 'phone': '972-4-6495488'}], 'overallOfficials': [{'name': 'Joel Geslevich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'haemek medical center'}, {'name': 'Eliezer Shalev', 'role': 'STUDY_CHAIR', 'affiliation': 'HaEmek Medicak Center and Technion, Israel Institute of Technology'}, {'name': 'Shlomit Goldman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'haemek medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technion, Israel Institute of Technology', 'class': 'OTHER'}]}}}