Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
Study NCT ID:
NCT04233892
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2020-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of in Situ Regeneration of Endometrium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000605742', 'term': 'basic fibroblast growth factor-kidney disease domain-collagen-binding domain fusion protein, mouse'}, {'id': 'D003094', 'term': 'Collagen'}, {'id': 'D004967', 'term': 'Estrogens'}], 'ancestors': [{'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D016326', 'term': 'Extracellular Matrix Proteins'}, {'id': 'D012596', 'term': 'Scleroproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 345}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse event rate', 'timeFrame': '24 months', 'description': 'The occurrence of infections, allergies, abdominal pain, uterine perforation and etc.'}], 'primaryOutcomes': [{'measure': 'Endometrial thickness', 'timeFrame': '6 months', 'description': 'Endometrial thickness evaluated by transvaginal sonography during late proliferative phase'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '24 months', 'description': 'The presence of a living intrauterine fetus on TVU at the 12th week of gestation'}], 'secondaryOutcomes': [{'measure': 'Endometrial blood flow', 'timeFrame': '6 months', 'description': 'Endometrial blood flow evaluated by transvaginal sonography'}, {'measure': 'Pregnancy related complications', 'timeFrame': '24 months', 'description': 'Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications'}, {'measure': 'Histological changes of endometrium', 'timeFrame': '12 months', 'description': 'Histological changes of the thin endometrium before and after treatment'}, {'measure': 'Menstrual blood volume', 'timeFrame': '6 months', 'description': 'The change of menstrual blood volume after treatment compared with pre-treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thin endometrium', 'infertility'], 'conditions': ['Infertility, Female, of Uterine Origin', 'Endometrial Fibrosis']}, 'descriptionModule': {'briefSummary': 'Thin endometrium will lead to hypomenorrhea，infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. Patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. This randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.Patients with thin endometrium (4mm≤ EMT \\<7mm )or scarred endometrium (scarred area≤70%) which is nonresponsive to estrogen stimulation 2.Infertile patients with clear fertility desires 3.20-42 years old 4.Normal ovarian function or with frozen embryos 5.Willing to participate in follow-up\n\nExclusion Criteria:\n\n1. Endometrial thickness \\<4mm or scarred endometrial area\\>70%\n2. Uterine cavity out of shape and the cavity depth\\<6.5mm\n3. Abnormal chromosome karyotype\n4. Uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis\n5. Systemic diseases: hypertension, diabetes, and so on\n6. Contraindications to pregnancy\n7. Contraindications to hormone replacement therapy\n8. Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other clinical studies\n\n10\\. Unable to adhere to the follow-up'}, 'identificationModule': {'nctId': 'NCT04233892', 'briefTitle': 'Clinical Study of in Situ Regeneration of Endometrium', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Clinical Study of in Situ Regeneration of Endometrium', 'orgStudyIdInfo': {'id': 'SC201900202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBD-bFGF', 'interventionNames': ['Drug: CBD-bFGF']}, {'type': 'EXPERIMENTAL', 'label': 'Collagen/BMMNCs', 'interventionNames': ['Drug: Collagen/BMMNCs']}, {'type': 'EXPERIMENTAL', 'label': 'Estrogen', 'interventionNames': ['Drug: Estrogen']}], 'interventions': [{'name': 'CBD-bFGF', 'type': 'DRUG', 'description': 'CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound', 'armGroupLabels': ['CBD-bFGF']}, {'name': 'Collagen/BMMNCs', 'type': 'DRUG', 'description': 'A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound', 'armGroupLabels': ['Collagen/BMMNCs']}, {'name': 'Estrogen', 'type': 'DRUG', 'description': 'Patients will receive regular estrogen therapy', 'armGroupLabels': ['Estrogen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yali Hu, MD,PhD', 'role': 'CONTACT', 'email': 'glyyhuyali@163.com', 'phone': '025-83106666', 'phoneExt': '11201'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Yali Hu, MD,PhD', 'role': 'CONTACT', 'email': 'glyyhuyali@163.com', 'phone': '025-83106666', 'phoneExt': '11201'}], 'overallOfficials': [{'name': 'Yali Hu, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Drum Tower Hospital of Nanjing University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yali Hu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor，Chief Physician of Obstetrics and Gynecology', 'investigatorFullName': 'Yali Hu', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}