Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-03 @ 6:39 AM
Study NCT ID:
NCT01805505
Status:
TERMINATED
Last Update Posted:
2017-03-07
First Post:
2013-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}}, 'statusModule': {'whyStopped': 'slow recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-05', 'studyFirstSubmitDate': '2013-03-01', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': 'At performing the pregnancy test 11 days post-embryo transfer', 'description': 'Proportion of patients with a positive pregnancy test'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': 'At first pregnancy ultrasound (3 weeks post-embryo transfer)', 'description': 'Proportion of patients with at least one gestational sac at first pregnancy ultrasound'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': 'At 10 weeks post-embryo transfer', 'description': 'Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer'}, {'measure': 'Menstruation-like pain', 'timeFrame': 'At embryo transfer', 'description': 'Measured on a three-level scale (none/mild/strong)'}, {'measure': 'Discomfort related to vesical distension', 'timeFrame': 'At embryo transfer', 'description': 'Measured on a three-level scale (none/mild/strong)'}, {'measure': 'Overall discomfort', 'timeFrame': 'At embryo transfer', 'description': 'Measured on a three-level scale (none/mild/strong)'}, {'measure': 'Difficulty using the assigned technique faced by operators', 'timeFrame': 'At embryo transfer', 'description': 'Measured on a three-level scale (easy/moderately difficult/very difficult)'}, {'measure': 'Catheterization time', 'timeFrame': 'At embryo transfer'}, {'measure': 'Conversion to the opposite technique', 'timeFrame': 'At embryo transfer', 'description': 'Proportion of cases in which embryo transfer was performed using the technique of the opposite randomization arm (i.e., proportion of patients randomized to have transabdominal ultrasound-guided transfer in whom transvaginal ultrasound-guided was performed, and the other way around)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Female infertility', 'Oocyte donation', 'Embryo transfer', 'Transvaginal ultrasonography', 'Transabdominal ultrasonography'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal ultrasound guidance was proposed recently to provide better visualization and reduce patient discomfort as embryo transfer can be performed with an empty bladder in this case. The purpose of this study is to determine whether there are any differences between transvaginal and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient satisfaction, and treatment outcome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing oocyte donation treatment with transfer of 2 embryos on day 3\n\nExclusion Criteria:\n\n* Submucous or \\>3 cm intramural fibroids\n* Turner syndrome\n* Black recipients'}, 'identificationModule': {'nctId': 'NCT01805505', 'briefTitle': 'Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'IVI Madrid'}, 'officialTitle': 'Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound', 'orgStudyIdInfo': {'id': 'MAD-EH-01-2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transvaginal ultrasound-guided embryo transfer', 'description': 'Transvaginal ultrasound-guided transfer of two day-3 embryos', 'interventionNames': ['Procedure: Transvaginal ultrasound-guided embryo transfer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transabdominal ultrasound-guided embryo transfer', 'description': 'Transabdominal ultrasound-guided transfer of two day-3 embryos', 'interventionNames': ['Procedure: Transabdominal ultrasound-guided embryo transfer']}], 'interventions': [{'name': 'Transvaginal ultrasound-guided embryo transfer', 'type': 'PROCEDURE', 'otherNames': ['Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan)'], 'description': 'Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound', 'armGroupLabels': ['Transvaginal ultrasound-guided embryo transfer']}, {'name': 'Transabdominal ultrasound-guided embryo transfer', 'type': 'PROCEDURE', 'otherNames': ['Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA)'], 'description': 'Embryo transfer of two day-3 embryos performed with the Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA), guided by transabdominal ultrasound', 'armGroupLabels': ['Transabdominal ultrasound-guided embryo transfer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28023', 'city': 'Madrid', 'country': 'Spain', 'facility': 'IVI Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Erik E Hauzman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Madrid'}, {'name': 'Juan A Garcia-Velasco, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IVI Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}