Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
30 participants
INTERVENTIONAL
2017-06-20
2019-10-01
Brief Summary
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The 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group using Propofol
Sedation will be established by administering 100mcs of Fentanyl, and 1-1.5mg/kg of body weight of Propofol.
No interventions assigned to this group
Study group Midazolam group
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.
Midazolam
The impact of Midazolam levels in follicular fluid.
Interventions
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Midazolam
The impact of Midazolam levels in follicular fluid.
Eligibility Criteria
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Inclusion Criteria
* Age \>18 - ≤ 38 years.
* BMI 19-30
* Stimulation in GnRH-antagonist protocol, using rFSH
* Expected normal ovarian response (6)
* At least 4 follicles with the size ≥ than 17 mm on the day of OPU
* Patients undergoing PGS
* Able to understand the aim of the study and to provide consent
Exclusion Criteria
* Severe male factor
18 Years
38 Years
FEMALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Prof Dr. Human Fatemi
Medical Director
Principal Investigators
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Human Mo Fatemi, MD
Role: PRINCIPAL_INVESTIGATOR
IVI Middle East Clinic
Locations
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IVI Middle East Fertilty Clinic
Abu Dhabi, , United Arab Emirates
Countries
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Related Links
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Follicular fluid levels of midazolam, fentanyl, and alfentanil during transvaginal oocyte retrieval.
Midazolam/ketamine sedative combination compared with fentanyl/propofol/isoflurane anaesthesia for oocyte retrieval.
Other Identifiers
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1610-ABU-074-HF
Identifier Type: -
Identifier Source: org_study_id
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