Ignite Creation Date:
2025-12-25 @ 4:39 AM
Ignite Modification Date:
2026-03-03 @ 2:20 PM
Study NCT ID:
NCT03317418
Status:
UNKNOWN
Last Update Posted:
2022-06-23
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Pregnancy be Predicted According to ATR-FTIR Spectrophotometry of Incubation Medium of Embryos in IVF
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': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2017-10-18', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spectrometry in embryo culture media', 'timeFrame': 'One year', 'description': 'Definition of spectrometry in embryo culture media'}, {'measure': 'Embryo quality', 'timeFrame': 'One year', 'description': 'The spectrometry results will be linked to embryo quality through the linkage between spectrometry results as indicated on Absorbance Graph and embryo quality judged by accepted criteria'}], 'secondaryOutcomes': [{'measure': 'Cycle outcomes', 'timeFrame': 'One year', 'description': 'Prediction of pregnancy rates as linked to the spectrometry results of the culture media'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the variability of culture media composition based on the ATR-FTIR (Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy) technique on the day of embryo transfer/vitrification. In addition, the study will explore whether variations detected in the culture medium can be linked to embryo quality and the chances of achieving pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women attending the fertility clinic at Hillel Yaffe Medical Center', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing IVF treatments with at least 4 embryos\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03317418', 'briefTitle': 'Can Pregnancy be Predicted According to ATR-FTIR Spectrophotometry of Incubation Medium of Embryos in IVF', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Can Pregnancy be Predicted According to ATR-FTIR Spectrophotometry of Incubation Medium of Embryos in IVF', 'orgStudyIdInfo': {'id': 'HYMC-0071-17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ATR-FTIR Spectrophotometry', 'type': 'OTHER', 'description': 'Spectrometry imaging'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Nardin Aslih, MD', 'role': 'CONTACT', 'email': 'nardin_aslih@yahoo.com'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Nardin Aslih, MD', 'role': 'CONTACT', 'email': 'nardin_aslih@yahoo.com', 'phone': '972-54-4843909'}], 'overallOfficials': [{'name': 'Einat Shalom Paz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}