Objectives: to compare the effects of general anesthesia vs. spinal anesthesia on the outcome of fertilization in patients undergoing in vitro fertilization.
Design: a randomized prospective clinical trial, during a 2 years period
Setting and conduct: after taking informed written consent, 200 patients entered the study; 100 in each group.
Participants including major eligibility: 200 female patients, women aged 20 to 40 years.
There were a number of criteria for entering and exit the study which were mentioned as inclusion and exclusion criteria:
The inclusion and exclusion criteria were as follows:
elective surgery;
informed written consent for performing anesthesia in the form of general or spinal;
Exclusion criteria were:
patient refusal for entering the study;
lack of appropriate NPO time;
any contraindication for performing spinal anesthesia including patient refusal for spinal anesthesia;
spinal deformities;
previous spinal surgery;
pre-existing coagulopathy;
platelet disorders;
chronic pain syndromes;
history of drug abuse;
cardiovascular diseases;
uncontrolled hypertension.
Interventions: one group receiving spinal anesthesia and the other, receiving general anesthesia. Ovum retrieval protocols were the same.
Main outcome measures: The success rate of fertilization was compared between the two groups. Nonparametric and parametric analysis was used for data analysis. P value less than 0.05 was considered significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810192804N3
Registration date:2012-01-07, 1390/10/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-07, 1390/10/17
Registrant information
Name
Ali Dabbagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2572
Email address
alidabbagh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pregnancy outcome using general anesthesia versus spinal anesthesia for In Vitro Fertilization
Public title
Pregnancy outcome using general anesthesia versus spinal anesthesia for In Vitro Fertilization
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion and exclusion criteria were as follows:
elective surgery;
informed written consent for performing anesthesia in the form of general or spinal;
Exclusion criteria were:
patient refusal for entering the study;
lack of appropriate NPO time;
any contraindication for performing spinal anesthesia including patient refusal for spinal anesthesia;
spinal deformities;
previous spinal surgery;
pre-existing coagulopathy;
platelet disorders;
chronic pain syndromes;
history of drug abuse;
cardiovascular diseases;
uncontrolled hypertension
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IRB ethics committee, Research Deputy, Tehran University of Medical Sciences, Tehran, Iran
Street address
IRB ethics committee, Research Deputy, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2011-09-12, 1390/06/21
Ethics committee reference number
130/1200/ص/90
Health conditions studied
1
Description of health condition studied
IVF patients
ICD-10 code
N98.2
ICD-10 code description
Complications of attempted introduction of fertilized ovum following in vitro fertilization
Primary outcomes
1
Description
pregnancy success after using IVF for pregnancy
Timepoint
2 year
Method of measurement
beta-hCG test 2 weeks after IVF and sonographic evaluation 6 weeks after IVF
Secondary outcomes
empty
Intervention groups
1
Description
the anesthesia method was different between the two groups:
in the first group, 100 patients received general anesthesia.
Category
Treatment - Other
2
Description
In the second group, 100 patients received spinal anesthesia.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
4th Alley, Nejatollahi St, Mirza Kuchak Khan Hospital, Aff. to School of Medicine, Tehran University
Full name of responsible person
Ali Dabbagh
Street address
Cardiac Anesthesiology Dept. Sa'adat Abad,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotoohi
Street address
Ghods St. Keshavarz Blvd. Central Campus, Vice chancellor for research, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Grant name
پایان نامه و بدون بودجه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Anesthesiology Research Center, Shahid Beheshti University of Medicine
Full name of responsible person
Ali Dabbagh
Position
Associate Professor, Fellowship in Cardiac Anesthesiology, Anesthesiology Research Center, Shahid Be
Other areas of specialty/work
Street address
Cardiac Anesthesiology Dept. Modarres Hospital, Sa'adat Abad
City
Tehran
Postal code
Phone
+98 21 2243 2572
Fax
Email
alidabbagh@yahoo.com;
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Research Center, Shahid Beheshti University of Medicine
Full name of responsible person
Ali Dabbagh
Position
Associate Professor, Fellowship in Cardiac Anesthesiology
Other areas of specialty/work
Street address
Cardiac Anesthesiology Dept. Modarres Hospital, Sa'adat Abad
City
Tehran
Postal code
Phone
+98 21 2243 2572
Fax
+98 21 2243 2571
Email
alidabbagh@yahoo.com;
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Research Center, Shahid Beheshti University of Medicine
Full name of responsible person
Ali Dabbagh
Position
Associate Professor, Fellowship in Cardiac Anesthesiology
Other areas of specialty/work
Street address
Cardiac Anesthesiology Department, Modarres Hospital, Sa'adat Abad
City
Tehran
Postal code
Phone
+98 21 2243 2572
Fax
+98 21 2243 2572
Email
alidabbagh@yahoo.com;
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)