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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04397393
Other study ID # 1910-ABU-090-NE
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date August 10, 2020

Study information

Verified date December 2020
Source ART Fertility Clinics LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary aim is to verify if camel milk consumption has an impact on the amount of Midazolam needed to achieve a satisfactory level of sedation for oocyte retrieval, compared to patients never having consumed camel milk.


Description:

A pilot study will be performed on patients undergoing oocyte retrieval (OPU) for the first time, and correlated to camel milk consumption versus never consumed camel milk, as well as age, BMI (body mass index), number of follicles at the time of OPU, number of previous OPUs in other clinics, previous vaginal delivery, past medical history positive for chemo therapy, alcohol consumption, use of prescribed or illicit drugs, or chronic pain medication. The main objective is to analyse if the consumption of camel milk, the frequency, or lack thereof correlates with the amount of the sedative drug Midazolam needed to achieve an acceptable level of sedation in order to estimate the dosage needed in both patient groups more adequately, reducing either discomfort felt at a too low an initial dosage, as well as avoiding a deeper level of sedation than needed with subsequent prolonged stay in recovery and unpleasant feelings of dizziness and drowsiness, potentially requiring antagonizing Midazolam by the use of Flumazenil, and reducing overall costs and length of stay in recovery and bed occupancy and enhancing patient experience and satisfaction. Would this study enable the Investigators to determine further effect of camel milk on other drugs used for various other purposes, and lead to a change in dose regimen?


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date August 10, 2020
Est. primary completion date August 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 48 Years
Eligibility Inclusion Criteria: - Arab origin - Female 18 -48 years of age - BMI < 37 kg/m2 - All ovarian stimulation protocols Exclusion Criteria: - Previous oocyte retrieval at our center - Post chemo therapy - Illicit drug use - Chronic pain medication - Medication which is known to increase the activity of liver enzymes - Any alcohol consumption - Previous vaginal delivery

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Midazolam
Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU

Locations

Country Name City State
United Arab Emirates IVI Middle East Fertility Clinic Abu Dhabi

Sponsors (1)

Lead Sponsor Collaborator
ART Fertility Clinics LLC

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU Mean dosage of Midazolam for both groups (Camel milk consumption vs no camel milk consumption 1 day
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