Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-07 @ 12:46 AM
Study NCT ID:
NCT02948205
Status:
UNKNOWN
Last Update Posted:
2016-10-28
First Post:
2016-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of TU-LESS by 3D Laparoscopy in the Treatment of Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'in 24 hours after surgery', 'description': 'Visual Analogue Score for the pain feeling of the patient'}, {'measure': 'pregnancy rate', 'timeFrame': '6 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Operation time', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infertility, TU-LESS, 3D laparoscopy'], 'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'This study intends to carry out a prospective, randomized controlled trial to compare the trans-umbilical laparoendoscopic single-site surgery by 3D laparoscopy with normal laparoendoscopic surgery in the treatment of infertility patient, so as to further clarify the safety and curative effect of TU-LESS by 3D laparoscopy and provide evidence-based basis for its application in infertility population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients are younger than 36 and older than 24.\n2. Clearly diagnosed with female Infertility.\n3. Infertility within 1 to 10 years.\n4. informed consent form signed\n\nExclusion Criteria:\n\n1. Over the age of 35.\n2. Indefinite diagnosis.\n3. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs).\n4. abdominal surgery history\n5. Unwilling to comply with the research plan.'}, 'identificationModule': {'nctId': 'NCT02948205', 'briefTitle': 'Analysis of TU-LESS by 3D Laparoscopy in the Treatment of Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'Analysis of Trans-umbilical Laparoendoscopic Single-site Surgery by 3D Laparoscopy in the Treatment of Infertility', 'orgStudyIdInfo': {'id': 'ShanghaiFMIH-3D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D group', 'description': 'infertility patient get TU-LESS by 3D Laparoscopy', 'interventionNames': ['Procedure: 3D group']}, {'type': 'OTHER', 'label': 'normal group', 'description': 'infertility patient get normal laparoscopic surgery', 'interventionNames': ['Procedure: normal group']}], 'interventions': [{'name': '3D group', 'type': 'PROCEDURE', 'description': 'infertility patient get TU-LESS by 3D Laparoscopy', 'armGroupLabels': ['3D group']}, {'name': 'normal group', 'type': 'PROCEDURE', 'description': 'infertility patient get normal laparoscopic surgery', 'armGroupLabels': ['normal group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}