Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 2:07 AM
Study NCT ID:
NCT07004192
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of hCG in Thawed Embryo Transfer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Third trimester of pregnancy', 'description': 'Mean arterial pressure measured in third trimester of pregnancy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thawed embryo transfer'], 'conditions': ['Infertility (IVF Patients)']}, 'descriptionModule': {'briefSummary': 'This prospective randomized trial will assess the relevance, if any, of a corpus luteum induced by hCG in transfers of thawed embryos.', 'detailedDescription': 'The current study is designed to carefully isolate the effect of a corpus luteum by ensuring that the presence or absence of a corpus luteum is the only difference between two study arms. This should be reliably achieved by administering an injection of hCG in one study arm, while the other study arm has identical treatment except for omitting the hCG.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female adult expecting to receive transfer of a thawed embryo.\n2. At least one available frozen blastocyst of transferrable quality.\n3. Non-menopausal female with at least one antral follicle.\n4. Use of pre-implantation genetic testing (PGT), embryos derived from donor oocytes and/or donor sperm, a gestational carrier, and history of prior transfer(s) regardless of outcome are allowed.\n5. Subsequent embryo transfers after failed transfers under this study are allowed, but not after a transfer that has resulted in ongoing pregnancy at ten weeks gestation under this study.\n\nExclusion Criteria:\n\n1. Minors (age\\<18 years).\n2. Use of embryo(s) frozen at another center.\n3. Patient insistent on transfer of two embryos.\n4. Patient or partner unable to provide informed consent in English.\n5. Patient already enrolled in any other research study for her embryo transfer.\n6. History of anti-phospholipid syndrome or any other indication for use of Lovenox in pregnancy.\n7. Patient for whom the physician assesses this protocol is inappropriate or unsafe.'}, 'identificationModule': {'nctId': 'NCT07004192', 'briefTitle': 'The Role of hCG in Thawed Embryo Transfer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fertility Center of Las Vegas'}, 'officialTitle': 'The Role of hCG in Thawed Embryo Transfer', 'orgStudyIdInfo': {'id': 'FCLV 2025-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hCG Group', 'description': 'This group receives one injection of hCG.', 'interventionNames': ['Drug: HCG injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No hCG Group', 'description': 'This arm receives no hCG.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'HCG injection', 'type': 'DRUG', 'description': '5000 IU hCG injection', 'armGroupLabels': ['hCG Group']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'No hCG administered in this group.', 'armGroupLabels': ['No hCG Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shironda Research Assistant', '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 Research Assistant', 'role': 'CONTACT', 'email': 'shironda@fertilitycenterlv.com', 'phone': '702-254-1777', 'phoneExt': '265'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No current plan to do so in approved protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fertility Center of Las Vegas', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Bruce Shapiro M.D.', 'investigatorAffiliation': 'Fertility Center of Las Vegas'}}}}