Comparison of Remifentanil-Propofol vs. Alfentanil-Propofol on fertilization and pregnancy rates in assisted reproductive( IVF-ICSI) patients referred to the Fertility Center of Fatemeh Zahra
This study compared the analgesic effect of remifentanil and alfentanil on the results and success rate of assisted reproductive technology (ART) including in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICST) was performed.100 cases of women using assisted reproductive techniques for pregnancy, in the age group 18-35 years were enrolled. Patients were divided randomly into two groups.Induction of anesthesia was performed in both groups with propofol 2 mg/ kg. For the first group Alfentanil 20 micrograms /kg and for second group remifentanil 1micrograms/kg was administered. For maintain of anesthesia in both groups was used of infusion of propofol with a dose of 100 micrograms /kg/min. Blood pressure, heart rate and oxygen saturation were measured and recorded every 5 minutes. It also the number of aspirated oocytes, fertilization is done and the number of embryos that were transferred was recorded. The recovery time was measured after discontinuing of drug infusion, based on open eyes on command. The incidence of postoperative nausea and vomiting were also studied. Beta-HCG was evaluated 15-17 days after embryo transfer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104096148N1
Registration date:2012-06-12, 1391/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-12, 1391/03/23
Registrant information
Name
Hakimeh Alreza Amiri
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
halereza@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-06-10, 1390/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Remifentanil-Propofol vs. Alfentanil-Propofol on fertilization and pregnancy rates in assisted reproductive( IVF-ICSI) patients referred to the Fertility Center of Fatemeh Zahra
Public title
Comparison of Remifentanil-Propofol vs Alfentanil-Propofol on fertilization and pregnancy rates in assisted reproductive
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile Women who use assisted reproductive techniques for pregnancy
Exclusion criteria: Women over 40 years, patients with psychological disorders and addiction.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University Of Medical Sciences
Street address
Daneshgah Sq - Ganjafrooz St
City
Babol
Postal code
Approval date
2011-04-27, 1390/02/07
Ethics committee reference number
3546/1/30/ژ/پ
Health conditions studied
1
Description of health condition studied
In Vitro Fertilization
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Rate of pregnancy
Timepoint
15-17 days after Embryo transfer
Method of measurement
Pregnancy Test
Secondary outcomes
1
Description
Formation of fetus
Timepoint
3 days after the puncture of ovarian follicle
Method of measurement
The number of formation of fetus
2
Description
Post operative of nausea & Vomiting
Timepoint
After Anesthesia
Method of measurement
Question & observation
3
Description
Recovery time after anesthesia
Timepoint
Waking up after discontinuation of drug infusion
Method of measurement
Discontinuation of the infusion time to open eyes with a call
Intervention groups
1
Description
In the control group, induction of anesthesia with alfentanil 20 microgram/kg and 2 mg /kg propofol for oocyte aspiration of ovarian follicles are prescribed.
Category
Treatment - Drugs
2
Description
The first group, the induction of general anesthesia with 1 microgram/kg for remifentanil and propofol 2 mg/kg body weight for oocyte aspiration of ovarian follicles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and Reproductive Health Research Center
Full name of responsible person
Dr Hakimeh Alereza
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol 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
Babol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
Email
halereza@yahoo.com , ans_dep@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
Email
halereza@yahoo.com , ans_dep@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babaol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)