Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-26 @ 5:42 PM
Study NCT ID:
NCT06133803
Status:
UNKNOWN
Last Update Posted:
2024-02-21
First Post:
2023-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lovenox With Aspirin in Thawed Blastocyst Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], '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'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D004624', 'term': 'Embryo Transfer'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized trial comparing treatment to controls.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum hCG level', 'timeFrame': '5 days post transfer', 'description': 'Serum hCG level'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': "This prospective randomized trial will compare outcomes in patients receiving aspirin in combination with a low-molecular weight heparin and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates.", 'detailedDescription': "This prospective randomized trial will compare outcomes in patients receiving aspirin (81mg daily) in combination with a low-molecular weight heparin (LMWH) (enoxaparin (Lovenox®), 40mg daily subcutaneous injection) and those under this center's standard protocol receiving neither medication, in order to determine if these medications may improve success rates."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female seeking pregnancy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female patient 18-42 years of age with frozen embryos or oocytes seeking embryo transfer.\n2. Use of pre-implantation genetically tested (PGT) blastocysts is allowed but not required.\n3. Use of donated embryos or embryos derived from donated eggs is allowed.\n4. Prior history of successful, failed, and/or canceled IVF cycles are allowed.\n\nExclusion Criteria:\n\n1. Minor (age\\<18 years).\n2. Currently pregnant.\n3. Unable to provide informed consent in English.\n4. Gestational carrier or "surrogate".\n5. Blastocysts frozen at another center (Oocytes frozen elsewhere is acceptable).\n6. Subject intending or having "natural cycle" thaw transfer with an active ovarian follicle present.\n7. Currently participating in any other research study.\n8. Subject already had an embryo transfer under this study.\n9. History of thrombocytopenia (reduced platelets), bleeding disorders, or routinely using anti-coagulant medication.\n10. Hypersensitivity to aspirin, heparin, or benzyl alcohol.\n11. Anyone for whom the physician assesses this protocol is inappropriate or unsafe.'}, 'identificationModule': {'nctId': 'NCT06133803', 'briefTitle': 'Lovenox With Aspirin in Thawed Blastocyst Transfer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fertility Center of Las Vegas'}, 'officialTitle': 'Lovenox With Aspirin in Thawed Blastocyst Transfer', 'orgStudyIdInfo': {'id': 'FCLV 2023-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Patients randomized to receive aspirin and Lovenox will begin taking one "low dose" 81mg aspirin and one 40mg injection of Lovenox daily, on the day of progesterone start.', 'interventionNames': ['Drug: Lovenox', 'Drug: Aspirin', 'Procedure: Embryo transfer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'This arm receives neither medication.', 'interventionNames': ['Procedure: Embryo transfer']}], 'interventions': [{'name': 'Lovenox', 'type': 'DRUG', 'description': 'A low-molecular-weight heparin, 40mg daily injection.', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Aspirin', 'type': 'DRUG', 'description': 'Aspirin 81mg daily tablet.', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Embryo transfer', 'type': 'PROCEDURE', 'description': 'Embryo transfer', 'armGroupLabels': ['Control Arm', 'Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89117', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shironda Anderson, BA', 'role': 'CONTACT', 'email': 'Shironda@fertilitycenterlv.com', 'phone': '702-254-1777', 'phoneExt': '265'}], 'facility': 'Fertility center of Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'centralContacts': [{'name': 'Shironda Anderson', 'role': 'CONTACT', 'email': 'shironda@fertilitycenterlv.com', 'phone': '702-254-1777'}], 'overallOfficials': [{'name': 'Bruce Shapiro, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fertility Center of Las Vegas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fertility Center of Las Vegas', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}