Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-28 @ 1:40 PM
Study NCT ID:
NCT04867759
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Endometrial biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-04-29', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of uNK cells', 'timeFrame': '4 months', 'description': 'Measurement of level of uNK cells by flowcytometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Repeated Implantation Failure', 'ICSI Failure', 'uNatural Killer Cells']}, 'descriptionModule': {'briefSummary': 'uterine NK (uNK) cells are characterized by a high expression of CD56 (CD56brihgt), lack of CD16 expression, high secretion of cytokines and rather low cytotoxic activity. It has been shown that uNK cells increase in number during the late secretory phase and during early pregnancy. This study was designed to assess the possible role of uNK cells in repeated ICSI failure.', 'detailedDescription': 'For occurrence of the "window of implantation", the endometrium must proliferate, increase in thickness, then, after ovulation, adequately respond to progesterone, and become receptive. Ultrasound examination of the thickness and appearance of the endometrium is an easily performed means of assessing morphological changes occurring in the endometrium during the follicular phase, and is thus used as a measure to predict successful implantation. Indeed, several studies have reported a strong association between endometrial thickness and successful implantation. However, others failed to confirm such an association. The minimal adequate endometrial thickness for successful implantation, as measured in the late proliferative phase, varies between studies, with a range of 6-8 mm. However, although rare, some investigators have reported successful implantation in an endometrium of no more than 5 mm thickness.\n\nUterine NK cell testing can only be done via an endometrial biopsy. Uterine natural killer cells never come into direct contact with the fetal cells-they only have direct access to placental cells.The biopsy is performed on day 21 of your menstrual cycle, when the NK cell count is at its highest. The procedure is done at outpatient clinics and results take about two weeks to receive. If your NK cell activity reading is greater than 14 % on day 21 biopsy, then diagnosed with high levels of NK cell activity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with repeated implantation faikure', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with IVF/ICSI failures more than 2 times\n* Age 20-40 years\n\nExclusion Criteria:\n\n* prior uterine surgery\n* immunological disease\n* previous testing to uNK cells'}, 'identificationModule': {'nctId': 'NCT04867759', 'acronym': 'UNK', 'briefTitle': 'Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'uNK in ICSI failure'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.', 'interventionNames': ['Procedure: Endometrial Biopsy']}, {'label': 'Control group', 'description': 'On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.', 'interventionNames': ['Procedure: Endometrial Biopsy']}], 'interventions': [{'name': 'Endometrial Biopsy', 'type': 'PROCEDURE', 'description': 'On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3111', 'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Adel Elgergawy, MD', 'role': 'CONTACT', 'email': 'dradelali775@gmail.com', 'phone': '+201002057250'}], 'facility': 'Adel Elgergawy', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Ayman Dawoog, MD', 'role': 'CONTACT', 'email': 'ayman.dawood@med.tanta.edu.eg', 'phone': '+202020972067'}, {'name': 'Adel Elgergawy, MD', 'role': 'CONTACT', 'email': 'dradelali775@gmail.com', 'phone': '+201002057250'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 months', 'ipdSharing': 'YES', 'description': 'On valuable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mansoura University', 'class': 'OTHER'}, {'name': 'Benha University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Ayman S Dawood, MD', 'investigatorAffiliation': 'Tanta University'}}}}