Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-01-01 @ 5:09 AM
Study NCT ID:
NCT04741295
Status:
UNKNOWN
Last Update Posted:
2021-02-05
First Post:
2021-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'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': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early spontaneous abortion rate', 'timeFrame': 'Within three months after frozen embryo transfer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adenomyosis', 'Assisted Reproductive Technology']}, 'descriptionModule': {'briefSummary': 'In assisted reproductive technology, adenomyosis patients are characterized by lower clinical pregnancy rate, lower implantation rate and higher abortion rate. The purpose of this study is to explore whether low molecular weight heparin can reduce the abortion rate of adenomyosis patients in frozen thawed embryo transfer cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The basal serum level of FSH was less than 10 IU / L\n2. Diagnosed with adenomyosis by ultrasound\n3. The first frozen thawed embryo transfer cycle, by hormone replacement protocol\n4. Transfer at least one high quality frozen embryo;\n5. Patients agreed to use low molecular weight heparin after FET, and they were able to sign informed consent in person.\n\nExclusion Criteria:\n\n1. With abnormal karyotype;\n2. Accompanied with other uterine diseases: intrauterine adhesion, intramural myoma, moderate to severe endometriosis, congenital uterine malformation, endometrial tuberculosis, thin endometrium \\< 8mm on the day of transformation, etc;\n3. PCOS, RIF patients;\n4. There are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc;\n5. There were contraindications to hormone replacement therapy and low molecular weight heparin;\n6. Participating in other clinical studies;\n7. Unable to follow-up'}, 'identificationModule': {'nctId': 'NCT04741295', 'briefTitle': "Low Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome", 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University'}, 'officialTitle': "To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation", 'orgStudyIdInfo': {'id': 'SZ-2021-ADE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Adenomyosis patients in control group have normal luteal progesterone support.'}, {'type': 'EXPERIMENTAL', 'label': 'Low molecular weight heparin Group', 'description': 'Adenomyosis patients in Low molecular weight heparin group have Low molecular weight heparin in addition to normal luteal progesterone support.', 'interventionNames': ['Drug: Low molecular weight heparin']}], 'interventions': [{'name': 'Low molecular weight heparin', 'type': 'DRUG', 'description': 'Patients with adenomyosis were treated with low molecular weight heparin after frozen embryo transfer in addition to routine luteal support.', 'armGroupLabels': ['Low molecular weight heparin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li-jun Ding', 'investigatorAffiliation': 'Nanjing University'}}}}