Determination and Comparison of the Effect of Propofol and Dexmedetomidine on Fertility Rate in IVF Candidates
Design
In this randomized clinical trial, 78 infertile patients undergoing IVF treatment will be available and will be examined. The code of ethics will be obtained from the Ethics Committee of Shahid Beheshti University before starting the study. Inclusion criteria are infertility and being a candidate for IVF treatment, and exclusion criteria include cases where patient data are incomplete or cannot be followed up. Subjects were randomly assigned to one of the two groups receiving propofol or dexmedetomidine at standard recording doses and fertility rates were compared between the two groups using chi-square and Fisher tests and the significance level was 0.05.
Settings and conduct
Patients with Infertility Candidate in Laboratory Referred to Taleghani Hospital in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria are infertility and being a candidate for IVF treatment, and exclusion criteria include cases where patient data are incomplete or cannot be followed up.
Intervention groups
Infertility patients undergoing IVF treatment
Main outcome variables
This study addresses the question of whether the effect of propofol and doxmedetomidine on fertility rates in IVF candidates is different, in order to determine the best drug with appropriate outcomes in women undergoing IVF treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190121042444N2
Registration date:2020-05-13, 1399/02/24
Registration timing:registered_while_recruiting
Last update:2020-05-13, 1399/02/24
Update count:0
Registration date
2020-05-13, 1399/02/24
Registrant information
Name
faranak behnaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1174
Email address
faranak.behnaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of propofol and dexmedetomidine on fertility rate in patients candidate for IVF
Public title
Comparative effect of propofol and dexmedetomidine on fertility rate in patients candidate for IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility patients undergoing IVF treatment
Exclusion criteria:
Patients who need general anesthesia due to decreased oxygen satura
Age
From 18 years old to 48 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table this method, based on the table of random numbers, first the number of samples is entered using a computer and each double-digit code is assigned. The researcher randomly selects a point in the Weston line. Work continues until the sample size is complete
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher, the researcher who prescribes the drug, is blind In this study, Drugs 1 and Drugs 2 are anesthetized by Nerses. Here Ners knows type 1 and 2 and is placed at the discretion of the researcher, who is an anesthesiologist and unaware of type 1 or 2, so the researcher is blind here and the participants in the study are blind because type 1 And they don't know 2
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته ملی اخلاق در پزوهش های زیست پزشکی
Street address
Quds Town between South Flamak Vazravshan Iran Street, Saya Central Headquarters Ministry of Health and Medical Education Tayyee 13
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.SBMU.MSP.REC.1398.995
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97. 9
ICD-10 code description
Primary outcomes
1
Description
BMI
Timepoint
Before the intervention and one week after the intervention at the same time as the laboratory test for pregnancy
Method of measurement
Based on checklist and measurement
2
Description
Fertility
Timepoint
Before the intervention and One week after the intervention
Method of measurement
Positive / negative based on intravenous blood test for pregnancy test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, they were randomly assigned to a group under the intervention of propofol with a dose of 10-20 micrograms based on weight per minute.Then the success of the pregnancy is checked by fertility blood test one week after .
Category
Treatment - Drugs
2
Description
Intervention group: Another group under the dose of dexmedetomidine with a dose of 0.4-0.2 microgram based on weight per minute.Then the success of the pregnancy is checked by fertility blood test one week after .The two intervention groups are then compared in terms of the success of the pregnancy by artificial insemination
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital - Tehran
Full name of responsible person
atiyeh tizghadam
Street address
Yemen Street/Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
atiyeh.tizghadam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nahid Asadi
Street address
Yaman/Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2572
Email
nahidasadi25@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
25
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Behnaz
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
shardary/tajrish
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1174
Email
fraranak.behnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faranak Behnaz
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
shardary/Tajrish
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 1174
Email
faranak.behnaz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atiyeh Tizghadam
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Yaman/Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2274 1174
Email
atiyeh.tizghadam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available