Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT05966558
Status:
UNKNOWN
Last Update Posted:
2023-07-28
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 266}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2023-07-19', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.', 'timeFrame': '2 years', 'description': 'cesarean section scar niche will be measured by TVS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Section niche'], 'conditions': ['Cesarean Section Niche Impact on ART']}, 'descriptionModule': {'briefSummary': 'the presence of cesarean section niche has adverse effects on success of ART outcome', 'detailedDescription': 'A common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.\n\nIt has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. The presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in a private center.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women should have the following:\n\n * Aged from 18 - 37 years old.\n * Undergoing fresh ICSI cycles.\n * A normal uterus with no anomalies or pathologies.\n * At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system).\n * Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).\n\nExclusion Criteria:\n\n* Younger than 18 or older than 37 years old.\n* Congenital uterine abnormality or pathology.\n* Presence of a hydrosalpinx.\n* Chronic diseases which are not suitable for pregnancy.\n* ICSI cycles with fresh or frozen TESE samples.'}, 'identificationModule': {'nctId': 'NCT05966558', 'briefTitle': 'Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome', 'orgStudyIdInfo': {'id': '9385-22-3-2022'}}, 'contactsLocationsModule': {'locations': [{'zip': '44511', 'city': 'Zagazig', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'rana nabil, msc', 'role': 'CONTACT', 'email': 'rananabil51@gmail.com', 'phone': '01005899460'}, {'name': 'Eman ElGindy, MD, PhD', 'role': 'CONTACT', 'email': 'eman_elgindy2013@hotmail.com', 'phone': '01227491143'}], 'facility': 'Zagazig university', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'eman elgingy, M.D', 'role': 'CONTACT', 'email': 'eman_elgindy2013@hotmail.com', 'phone': '+20 122 749 1143'}, {'name': 'shahenda saleh, M.D', 'role': 'CONTACT', 'email': 'shahendasaleh20102015ss@gmail.com" <shahendasaleh20102015ss@gmail.com>', 'phone': '+20 100 110 9730'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of obstetrics and gynaecology', 'investigatorFullName': 'Rana Nabil Mohamed Attia', 'investigatorAffiliation': 'Zagazig University'}}}}