Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 1:12 PM
Study NCT ID:
NCT06036459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Peristalsis in IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2023-08-13', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy', 'timeFrame': '2 weeks after a positive pregnancy test', 'description': 'The presence of intrauterine gestational sac and fetal pole with positive cardiac pulsation by transvaginal ultrasound'}], 'secondaryOutcomes': [{'measure': 'Biochemical pregnancy', 'timeFrame': '2 weeks after embryo transfer', 'description': 'a positive serum human chorionic gonadotropin'}, {'measure': 'Miscarriage', 'timeFrame': 'From 6 weeks of gestation until 28 weeks of gestation', 'description': 'Pregnancy loss either loss of cardiac pulsation by ultrasound, or spontaneous loss of pregnancy vaginally'}, {'measure': 'Ectopic pregnancy', 'timeFrame': 'the site of the gestational sac will be assessed 2 weeks after embryo transfer', 'description': 'Pregnancy outside the uterine cavity'}, {'measure': 'Ongoing pregnancy', 'timeFrame': 'After 12 weeks of gestation until delivery', 'description': 'The presence of a viable pregnancy after 12 weeks of gestation'}, {'measure': 'Live birth', 'timeFrame': 'From 28 weeks of gestation until delivery', 'description': 'Delivery of a living foetus after the age of viability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': "An observational prospective cohort study to evaluate the effect of uterine peristalsis at the time of embryo transfer on IVF clinical outcomes performed in Women's Health hospital, Assiut University, Egypt.\n\nWomen performing fresh or frozen embryo transfer who do not have any uterine abnormalities will be included in the study"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergoing IVF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Women undergoing embryo transfer during IVF cycles.\n\n * Age: between 20 and 40 years.\n * Have at least 1 good quality embryo at the time of transfer\n * Fresh or frozen-thawed cycles.\n * Any stimulation protocol in fresh cycles, or any endometrial preparation protocol for frozen-thawed cycles\n\nExclusion Criteria:\n\n* • Women refusing to participate in clinical research.\n\n * Any uncorrected uterine abnormality, such as septum, myoma, adenomyosis, or polyp\n * Hydrosalpinx without prior disconnection or excision'}, 'identificationModule': {'nctId': 'NCT06036459', 'briefTitle': 'Uterine Peristalsis in IVF', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Uterine Peristalsis at the Time of Embryo Transfer on the Outcomes of IVF Cycles: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Uterine Peristalsis in IVF'}}, 'armsInterventionsModule': {'interventions': [{'name': 'uterine peristalsis', 'type': 'OTHER', 'description': 'Transabdominal us followed by Transvaginal ultrasonography scans (Sono Ace R5 ) of uterine peristalsis will performed on the day of embryo transfer while the patient lying relaxed in lithotomy position. The probe will be introduced into the vagina as gently as possible to avoid stimulating the cervix. After scanning the mid-sagittal plane of the uterus, the probe will be fixed as steady as possible while a 3 min video of uterine peristalsis will be recorded simultaneously. The records will be analyzed at 4X regular speed using a Video player application by two independent experienced observers. The uterine peristaltic wave frequency will be the mean of the results from each observer.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Karim Abdallah, MD', 'role': 'CONTACT', 'email': 'karimsayed88@aun.edu.eg', 'phone': '+201270595485'}], 'overallOfficials': [{'name': 'Mahmoud Abdelaziz, M.Sc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Karim Abdallah', 'investigatorAffiliation': 'Assiut University'}}}}