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?