Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 4:04 PM
Study NCT ID:
NCT02855632
Status:
UNKNOWN
Last Update Posted:
2018-01-05
First Post:
2016-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
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': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D004967', 'term': 'Estrogens'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-04', 'studyFirstSubmitDate': '2016-04-03', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Endometrial thickness', 'timeFrame': '1 months after G-CSF injection', 'description': 'Endometrial thickness in the ovulation phase after G-CSF injection'}], 'primaryOutcomes': [{'measure': 'Adhesion reformation rate', 'timeFrame': '2 months after first surgery', 'description': 'Adhesion reformation rate after first adhesiolysis'}], 'secondaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '3 years after first surgery', 'description': 'pregnancy rate after adhesiolysis'}, {'measure': 'Live birth rate', 'timeFrame': '4 years after first surgery', 'description': 'live birth rate after adhesiolysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['G-CSF', 'adhesion reformation', 'Asherman syndrome'], 'conditions': ['Intrauterine Adhesion']}, 'referencesModule': {'references': [{'pmid': '35147195', 'type': 'DERIVED', 'citation': 'Zhang Y, Chen X, Chen S, Wei C, Li B, Wang Z, Shen X, Lin X. Intrauterine administration of G-CSF for promoting endometrial growth after hysteroscopic adhesiolysis: a randomized controlled trial. Hum Reprod. 2022 Apr 1;37(4):725-733. doi: 10.1093/humrep/deac023.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.', 'detailedDescription': 'After hysteroscopic adhesiolysis, patients with moderate to severe intrauterine adhesions will be allocated into 2 groups randomly, with COOK ballon and estrogen and progesterone sequential therapy given to prevent adhesion routinely. 7 day later, G-CSF or normal saline will be injected into the uterine cavity by Tom catheter after removing the balloon respectively. A second hysteroscopic examination will be performed in 2 months to check up the adhesion reformation. In addition, the endometrial thickness after surgery and fertility outcome will be followed up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Moderate and severe intrauterine adhesion patients(AFS score ≥5)\n* age 18-40\n* first time receiving hysteroscopic adhesiolysis\n* provided COOK balloon as adjuvant adhesion prevention treatment\n* accepting randomized trial\n\nExclusion Criteria:\n\n* Mild adhesion patients\n* uterine shape can't be restored in the end of surgery\n* abnormal chromosome phenotype\n* systemic disease\n* no fertility desire\n* contradiction of G-CSF injection."}, 'identificationModule': {'nctId': 'NCT02855632', 'briefTitle': 'The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis', 'orgStudyIdInfo': {'id': 'SRRSHRMC2016001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G-CSF', 'description': 'G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.', 'interventionNames': ['Drug: G-CSF', 'Drug: hormone therapy', 'Other: Cook balloon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.', 'interventionNames': ['Drug: Normal saline', 'Drug: hormone therapy', 'Other: Cook balloon']}], 'interventions': [{'name': 'G-CSF', 'type': 'DRUG', 'otherNames': ['granulocyte colony-stimulating factor'], 'description': '7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.', 'armGroupLabels': ['G-CSF']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['0.9% NaCl', '0.9% sodium chloride'], 'description': '7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.', 'armGroupLabels': ['Normal saline']}, {'name': 'hormone therapy', 'type': 'DRUG', 'otherNames': ['Artificial cycle', 'Artificial menstrual cycle', 'Estrogen and Progesterone Sequential Therapy'], 'description': 'In all cases hormone therapy was commenced shortly after the operation, consisting of oestradiol valerate at a dose of 6 mg per day for 21-28 days with the addition of medroxyprogesterone acetate at a dose of 6 mg per day for the last 7-10 days of the oestrogen therapy. Following the withdrawal bleed, the hormone therapy was repeated for another cycle.', 'armGroupLabels': ['G-CSF', 'Normal saline']}, {'name': 'Cook balloon', 'type': 'OTHER', 'description': 'At the end of the procedure, the Cook balloon were placed in the uterine cavity of each patient.the device was removed after 7 days.', 'armGroupLabels': ['G-CSF', 'Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310018', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yamei Xue, Master', 'role': 'CONTACT', 'email': 'yaya7450@sina.com', 'phone': '+8657186002222'}], 'facility': 'Sir Run Run Shaw Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiaona Lin, Doctor', 'role': 'CONTACT', 'email': 'linna73@263.net', 'phone': '+8657186006252'}], 'overallOfficials': [{'name': 'Xiaona Lin, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Wenzhou people's hospital，zhejiang province,China", 'class': 'UNKNOWN'}, {'name': "Ningbo Women & Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xiaona Lin', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}