Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-02 @ 8:32 AM
Study NCT ID:
NCT03629132
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRP Prevents Recurrence of Intrauterine Adhesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006175', 'term': 'Gynatresia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AFS score', 'timeFrame': '1 year', 'description': 'AFS score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrauterine Adhesion']}, 'descriptionModule': {'briefSummary': 'Effect of platelet-rich plasma (PRP) on uterine scar fibrosis, endometrial receptivity and pregnancy outcome in patients with severe intrauterine adhesions', 'detailedDescription': '1. Inclusion criteria: patients with intrauterine adhesions (AFS score \\>9 points); age 21 to 40 years old, with fertility requirements.\n2. Study design:prospective, randomized controlled cohort study, patients with intrauterine adhesions were randomized into two groups, the control group and the intervention group (intraoperative and postoperative 1 week postoperative PRP). The surgical procedures and postoperative medication regimens were the same.\n3. Compare the biochemical pregnancy rate, clinical pregnancy rate, abortion rate and live birth rate after hysteroscopic resection in PRP group and control group, and explore the effect of PRP on pregnancy outcome after intrauterine adhesion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Patients with intrauterine adhesions (AFS score \\>9 points); age 21 to 40 years old, with fertility requirements -\n\nExclusion Criteria:Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03629132', 'acronym': 'RPR-IUAs', 'briefTitle': 'PRP Prevents Recurrence of Intrauterine Adhesions', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Platelet-rich Plasma(PRP) Prevents Recurrence of Intrauterine Adhesions', 'orgStudyIdInfo': {'id': 'RPR-IUAs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP', 'description': 'Platelet-rich plasma', 'interventionNames': ['Procedure: Platelet-rich plasma']}, {'type': 'SHAM_COMPARATOR', 'label': 'Gel', 'description': 'Self-crosslinking sodium hyaluronate gel', 'interventionNames': ['Procedure: gel']}], 'interventions': [{'name': 'Platelet-rich plasma', 'type': 'PROCEDURE', 'description': 'Platelet-rich plasma intrauterine injection', 'armGroupLabels': ['PRP']}, {'name': 'gel', 'type': 'PROCEDURE', 'description': 'Self-crosslinking sodium hyaluronate gel intrauterine injection', 'armGroupLabels': ['Gel']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yanhong Deng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yanhong Deng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}