Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT01184469
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2010-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Observational Study of Peri-implantation Serum hCG Levels
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-12', 'studyFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-08-17', 'lastUpdatePostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy', 'timeFrame': '10 weeks gestation', 'description': 'Fetal heart motion at 10 weeks gestation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively define a set of data suitable for developing models of pregnancy viability. Those models will be based on serum hCG concentration measured during the peri-implantation period in patients that received fresh embryo transfer and those that received transfer of frozen-thawed embryos, and to compare and contrast these models. This may reveal insights into differences between these types of IVF cycles.', 'detailedDescription': 'The current study seeks to examine the effect of the timing of implantation (as indicated by the first increase in serum hCG level) on the viability of pregnancies and to determine if such effect of timing differs between fresh embryo transfers and frozen-thawed embryos transfers. In this case, the timing of implantation will be measured through serum hCG analysis on days 3, 4, 5, and 7 after blastocyst transfer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IVF patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IVF patients (adults) who received blastocyst transfer\n\nExclusion Criteria:\n\n* Those patients using different laboratories'}, 'identificationModule': {'nctId': 'NCT01184469', 'briefTitle': 'Prospective Observational Study of Peri-implantation Serum hCG Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fertility Center of Las Vegas'}, 'officialTitle': 'Prospective Observational Study of Peri-implantation Serum hCG Levels', 'orgStudyIdInfo': {'id': 'SAIRB 10-0007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fresh embryo transfers', 'description': 'Patients who received fresh blastocyst transfer'}, {'label': 'Thawed embryo transfers', 'description': 'Patients who received transfers of frozen/thawed embryos'}]}, 'contactsLocationsModule': {'locations': [{'zip': '89117', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Fertility Center of Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bruce Shapiro M.D.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medica Director', 'investigatorFullName': 'Bruce Shapiro M.D.', 'investigatorAffiliation': 'Fertility Center of Las Vegas'}}}}