Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-10 @ 2:42 PM
Study NCT ID:
NCT05085067
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2021-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-10-09', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adhesion reformation rate at third-look hysteroscopy', 'timeFrame': 'A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.'}, {'measure': 'Adhesion score at third-look hysteroscopy', 'timeFrame': 'A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.'}, {'measure': 'Concentration of the menstrual pattern', 'timeFrame': 'at 3 months after the initial surgery'}, {'measure': 'Pregnancy rate', 'timeFrame': 'at 12-month after the initial surgery'}], 'secondaryOutcomes': [{'measure': 'Rate of complications', 'timeFrame': 'up to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retained Products of Conception', 'Hysteroscopy', 'Intrauterine adhesion', 'Auto-crossed-linked hyaluronic acid gel'], 'conditions': ['Retained Products of Conception']}, 'descriptionModule': {'briefSummary': 'Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception.\n\nAfter the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: \\[1\\] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; \\[2\\] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of retained products of conception\n* Written consent obtained\n\nExclusion Criteria:\n\n* Patients with severe complications of medicine and surgery\n* Acute or chronic genital tract inflammation\n* No understanding or approving the randomized controlled trial'}, 'identificationModule': {'nctId': 'NCT05085067', 'briefTitle': 'The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception', 'organization': {'class': 'OTHER', 'fullName': 'Fu Xing Hospital, Capital Medical University'}, 'officialTitle': 'The Efficacy of Auto-crosslinked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception:a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FXHV1.0-2020-11-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A: no auto-cross linked hyaluronic acid gel', 'description': 'no auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception'}, {'type': 'EXPERIMENTAL', 'label': 'Group B: infusing auto-cross linked hyaluronic acid gel', 'description': 'infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception', 'interventionNames': ['Other: auto-crossed-linked hyaluronic acid gel']}], 'interventions': [{'name': 'auto-crossed-linked hyaluronic acid gel', 'type': 'OTHER', 'description': 'infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception', 'armGroupLabels': ['Group B: infusing auto-cross linked hyaluronic acid gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100038', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xue Yang, Master', 'role': 'CONTACT', 'email': 'yuanxy515@163.com', 'phone': '+8618810957056'}, {'name': 'Rong L Huo, Doctor', 'role': 'CONTACT', 'email': 'fxyykjc2014@sina.com', 'phone': '+861088062032'}, {'name': 'Xue Yang, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'FuxingHospital，Captital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xue Yang, Master', 'role': 'CONTACT', 'email': 'yuanxy515@163.com', 'phone': '8618810957056'}, {'name': 'Rong Li Huo, Doctor', 'role': 'CONTACT', 'email': 'fxyykjc2014@sina.com', 'phone': '8601088062032'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Xing Hospital, Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Yang Xue', 'investigatorAffiliation': 'Fu Xing Hospital, Capital Medical University'}}}}