Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-07-06 @ 1:53 AM
Study NCT ID:
NCT04079959
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2019-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in IVF-ET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'endometrial samples will be stored'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2019-09-03', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'immune cell counting', 'timeFrame': 'up to 2 months', 'description': 'The counting method will be performed according to an agreed and published standardized protocol by a multicenter working group designed to reduce variance of results between centres. Ten images of 40X magnification fields will be analyzed for each sample. The first field to be captured should be selected at random, ensuring that it contained the luminal epithelial border. Subsequent fields should be obtained by moving one field to the left or right of the original field, keeping the luminal epithelial border in view.'}, {'measure': 'Quantification of endometrial immune cells spatial distribution', 'timeFrame': 'up to 2 months', 'description': 'In each 200 times under the microscope vision, based on the X and Y position of each single cell which InForm system could provide, the relative spatial distribution of each individual endometrial immune cell will be considered as a bivariate point pattern'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'Uterine natural killer (uNK) cells have been implicated to play a role in female reproductive performance. Serval studies showed an increased uNK cell density in the endometrium of women with reproductive failure. In this study, we wish to investigate the density and clustering of four different immune cells.', 'detailedDescription': 'Implantation is a process whereby the embryo attaches itself to the endometrium. In humans, the endometrium has a specific period of uterine receptivity, which occurs 5-7 days after ovulation and remains receptive for \\~4 days (cycle days 20-24), when embryo implantation starts. Implantation failure refers to the failure of the embryo to reach a stage when intrauterine gestational sac is recognized by ultrasonography. It occurs when the embryo is abnormal or when endometrial function is impaired.\n\nUterine natural killer (uNK) cells have been implicated to play a role in female reproductive performance. They comprise 70-80% of the total leukocyte population in the endometrium during implantation and early pregnancy. Several studies showed an increased uNK cell density in the endometrium of women with reproductive failure. To better understand the contribution of various immune factors to endometrial function and future pregnancy, it is proposed to examine the major immune cells in the same specimen to measure the relative magnitude of the cell density changes and the degree of clustering between two immune cell types.\n\nThe aim of this study is to investigate the endometrial leucocytes profile around the time of embryo implantation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergoing frozen embryo transfer.', 'genderDescription': 'Endometrial biopsies will be collected for all the participants', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing frozen embryo transfer.\n\nExclusion Criteria:\n\n* Women older than 40 years\n* Women who have any uterine anomaly or intrauterine pathology such as:\n\nEndometrial polyp or/ and Large fibroid with a diameter \\>4 cm\n\n* Visible hydrosalpinx on transvaginal ultrasound scans\n* BMI \\>35'}, 'identificationModule': {'nctId': 'NCT04079959', 'briefTitle': 'Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in IVF-ET', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in Vitro Fertilization- Embryo Transfer (IVF-ET)', 'orgStudyIdInfo': {'id': '2019.277'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women who are undergoing frozen embryo transfer', 'description': 'endometrial biopsy will be done one cycle before the frozen embryo transfer', 'interventionNames': ['Procedure: endometrial biopsy']}], 'interventions': [{'name': 'endometrial biopsy', 'type': 'PROCEDURE', 'description': '. Endometrial samples are obtained using a biopsy catheter as follows: the Pipette is inserted through the cervical os and advanced gently until resistance is felt. The inner piton of the device is then withdrawn to create suction, and the endometrial sample is obtained by moving the pipette up and down approximately 2-3 cm within the uterine cavity. The device is rotated 360° to ensure adequate coverage of the area.', 'armGroupLabels': ['women who are undergoing frozen embryo transfer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Xiaoyan Chen, PhD', 'role': 'CONTACT', 'email': 'chenxiaoyan@cuhk.edu.hk', 'phone': '85235053199'}, {'name': 'Wing Ching Cheung, PhD', 'role': 'CONTACT', 'email': 'cosycheung@cuhk.edu.hk', 'phone': '85235051764'}], 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Wing Ching Cheung, PhD', 'role': 'CONTACT', 'email': 'cosycheung@cuhk.edu.hk', 'phone': '85235051764'}, {'name': 'Xiaoyan Chen, PhD', 'role': 'CONTACT', 'email': 'chenxiaoyan@cuhk.edu.hk', 'phone': '85235051764'}], 'overallOfficials': [{'name': 'Xiaoyan Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Please contact the principle investigator if there is any enquiry'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Chen Xiaoyan', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}