Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-04 @ 8:58 AM
Study NCT ID:
NCT03756857
Status:
UNKNOWN
Last Update Posted:
2021-03-23
First Post:
2018-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, open, randomized, parallel, two-arm trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-21', 'studyFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '5-6 weeks after embryo transfer', 'description': 'the presence of gestational sac on ultrasound'}], 'secondaryOutcomes': [{'measure': 'implantation rate', 'timeFrame': '3-4 weeks after embryo transfer', 'description': 'the number of gestational sacs divided by the number of embryos transferred'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility', 'Assisted Reproductive Technology', 'IVF']}, 'descriptionModule': {'briefSummary': 'Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique', 'detailedDescription': 'Eligible patients will be informed about the possibility of participating in the clinical trial in the beginning of treatment and on the day ET, a signed consent form will be collected from those recipients who confirmed their participation. These patients will be randomized immediately before the ET procedure by sequentially numbered, opaque, sealed envelopes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient has given written informed consent\n2. BMI 18-30 kg/m2\n3. \\< 2 previous failed IVF trials\n4. At least two good quality embryos on the day of transfer\n\nExclusion Criteria:\n\n1. Congenital uterine anomaly\n2. Untreated endometrial polyp or fibroid distorting uterine cavity\n3. Presence of hydrosalpinx 4.2 or more prior IVF trial failure\n\n5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history'}, 'identificationModule': {'nctId': 'NCT03756857', 'briefTitle': 'Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem Kadiköy Hospital'}, 'officialTitle': 'Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique', 'orgStudyIdInfo': {'id': 'AcibademKD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afterload transfer', 'description': "First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician.", 'interventionNames': ['Procedure: Afterload Transfer']}, {'type': 'EXPERIMENTAL', 'label': 'Trial Followed by Transfer', 'description': 'First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed', 'interventionNames': ['Procedure: Trial followed by transfer']}], 'interventions': [{'name': 'Afterload Transfer', 'type': 'PROCEDURE', 'description': 'Embryo transfer is done by using "afterload transfer" method', 'armGroupLabels': ['Afterload transfer']}, {'name': 'Trial followed by transfer', 'type': 'PROCEDURE', 'description': 'Embryo transfer is done by using "afterload transfer" method', 'armGroupLabels': ['Trial Followed by Transfer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34662', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Elif Esra Uyar, MD', 'role': 'CONTACT', 'email': 'esra.uyar@acibadem.com', 'phone': '+902166494444'}], 'facility': 'Acibadem Altunizade Hospital, Unit of ART', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Elif Esra UYAR, MD', 'role': 'CONTACT', 'email': 'esra.uyar@acibadem.com', 'phone': '+902166494444'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem Kadiköy Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'deniz usal', 'investigatorAffiliation': 'Acibadem Kadiköy Hospital'}}}}