Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 2:38 AM
Study NCT ID:
NCT03049293
Status:
TERMINATED
Last Update Posted:
2021-05-06
First Post:
2017-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Midazolam Levels in Follicular Fluid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Difficulty in recruiting participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-02', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-02-09', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .', 'timeFrame': '6-12 months', 'description': 'To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD,IVF'], 'conditions': ['Midazolam Overdose']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/7589618', 'label': 'Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval.'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/10402383', 'label': 'Midazolam/ketamine sedative combination compared with fentanyl/propofol/isoflurane anaesthesia for oocyte retrieval.'}]}, 'descriptionModule': {'briefSummary': 'To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.\n\nThe reason to measure Midazolam levels in larger size follicles in this study is to maximize the chances to get a mature oocyte and therefore develop into a potential embryo to be analyzed.', 'detailedDescription': 'The correlation of Midazolam levels in follicular fluid and euploid status of the embryos is worth exploring as no data exists that suggests any influence on the quality of the embryos from using this substance for IVF since its earliest days. Measuring time lapsed from injection to first oocyte retrieval as well as time lapsed in between first and last oocyte retrieved will grand insight into the rise of levels of Midazolam inside the follicular fluid, correlated with the chromosomal status and the morphokinetic development of the euploid embryos.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertility (prim. / sec.)\n* Age \\>18 - ≤ 38 years.\n* BMI 19-30\n* Stimulation in GnRH-antagonist protocol, using rFSH\n* Expected normal ovarian response (6)\n* At least 4 follicles with the size ≥ than 17 mm on the day of OPU\n* Patients undergoing PGS\n* Able to understand the aim of the study and to provide consent\n\nExclusion Criteria:\n\n* History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.\n* Severe male factor'}, 'identificationModule': {'nctId': 'NCT03049293', 'briefTitle': 'Measurement of Midazolam Levels in Follicular Fluid', 'organization': {'class': 'OTHER', 'fullName': 'ART Fertility Clinics LLC'}, 'officialTitle': 'Measurement of Midazolam Levels in Follicular Fluid and Correlation of Midazolam Levels in Follicular Fluid and Oocyte Quality, Fertilization Rate, Embryo Development Pattern and Euploid Status', 'orgStudyIdInfo': {'id': '1610-ABU-074-HF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group using Propofol', 'description': 'Sedation will be established by administering 100mcs of Fentanyl, and 1-1.5mg/kg of body weight of Propofol.'}, {'type': 'EXPERIMENTAL', 'label': 'Study group Midazolam group', 'description': 'Sedation will be established by administering Midazolam 1mg, 100mcs of Fentanyl, and 0.5-1mg/kg of body weight of Propofol. Further boluses of Propofol will be given according to the need of the patient and time consumed for oocyte retrieval.', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Midazolam', 'type': 'DRUG', 'description': 'The impact of Midazolam levels in follicular fluid.', 'armGroupLabels': ['Study group Midazolam group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'IVI Middle East Fertilty Clinic', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'overallOfficials': [{'name': 'Human Mo Fatemi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVI Middle East Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ART Fertility Clinics LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Prof Dr. Human Fatemi', 'investigatorAffiliation': 'ART Fertility Clinics LLC'}}}}