A comparative study on some of the consequences of fetal transfer method under the guidance of transvaginal ultrasound and guidance through trans Abdominal ultrasound at Mahdieh Hospital in Tehran in 1399
Comparing the two methods of embryo transfer; under guidance of transvaginal and transabdominal ultrasound.
Design
The present study is a clinical trial study. 90 women candidates for IVF will enter the study using available sampling method and will be randomly divided into two groups with equal numbers.
Settings and conduct
In both groups of patients, vagina will be lubricated with 10 cc of lubricated gel and, depending on the operator's discretion, two SIVF catheter or Edwards-Wallace catheters will be used. To perform sonography, a Honda device made in China with H-S2000 probe will be used for abdominal ultrasound and H-S2100 probe will be used for vaginal ultrasound. Patient pain will be recorded in checklists during and after the procedure. After the study, the doctor will be asked how difficult it is to perform the procedure and the three-dimensional vision in the two methods studied, and it will be recorded in the questionnaire.
Also, the process time will be recorded by a stopwatch.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women between ages of 18 and 40, candidate for the embryo transfer.
Exclusion criteria: obesity (BMI above 35), anatomical problems of uterus, and patients' dissatisfaction to participate in study.
Intervention groups
First group: transvaginal ultrasound. Second group: transabdominal ultrasound.
Main outcome variables
Pain rate, Ultrasound imaging of physician, Duration of procedure, Successful pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046140N1
Registration date:2020-08-09, 1399/05/19
Registration timing:retrospective
Last update:2020-08-09, 1399/05/19
Update count:2
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Parya Geran Malekkheyli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 2233
Email address
navid.khoshbakht@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on some of the consequences of fetal transfer method under the guidance of transvaginal ultrasound and guidance through trans Abdominal ultrasound at Mahdieh Hospital in Tehran in 1399
Public title
comparison of the consequences of fetal transfer method under the guidance of transvaginal ultrasound and guidance through trans Abdominal ultrasound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women candidates for IVF
Exclusion criteria:
The patient's reluctance to participate in the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 90 women candidates for IVF will be included in the study by available sampling method. Using simple randomization method and individual unit, division of people into two groups will be done by Research Randomizer software, version 3.0 and random allocation with a ratio of 1: 1. In this software, a number will be assigned to each person entered in the study, and the software will randomly separate the numbers in two lists with a ratio of 1: 1.
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.870
Health conditions studied
1
Description of health condition studied
IVF
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain severity
Timepoint
During the ultrasound, At the end of the ultrasound
Method of measurement
Number one as the least pain and number ten as the most pain. Measuring of the variable will be done using the Numeric Pain Rating Scale method. In this method, the person rates their pain using a scale of 0 to 10. Zero means painless and 10 means the worst pain situation.
2
Description
Ultrasonic visualization of the doctor
Timepoint
At the end of the ultrasound
Method of measurement
Appropriate / inappropriate. This variable will be done by asking the doctor at the end of the ultrasound. In this way, the degree of difficulty and three-dimensional vision of the doctor using this method will be recorded based on the physician's opinion.
3
Description
Processing time
Timepoint
At the end of the ultrasound
Method of measurement
Second. The duration of the ultrasound at the end of the work will be recorded using a stopwatch in according to seconds.
4
Description
Successful pregnancy
Timepoint
It will be done 4 weeks after embryo transfer.
Method of measurement
Yes/No. Successful pregnancy will be recorded using beta-HCG measurement.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: transfer of the fetus to the uterus under the guidance of abdominal ultrasound. In this group, embryo transfer will take place on days 2 or 3, because pregnancy and the rate of implantation are higher on these days. Initially, the vaginal will be impregnated with 10 cc of lubricating gel, and two SIVF catheters or Edwards-Wallace catheters will be used, depending on the operator's discretion. A rigid external transmission catheter in the cervical canal will also be studied. In this group, the bladder should be full. Honda device made in China with H-S2000 probe will be used for ultrasound.
Category
Treatment - Devices
2
Description
Intervention group: transfer of the fetus to the uterus under the guidance of vaginal ultrasound. In this group, embryo transfer will take place on days 2 or 3, because pregnancy and the rate of implantation are higher on these days. Initially, the vagina will be impregnated with 10 cc of lubricating gel, and two SIVF catheters or Edwards-Wallace catheters will be used, depending on the operator's discretion. A rigid external transmission catheter in the cervical canal will also be studied. Honda device made in China with H-S2100 probe will be used for ultrasound.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Mahdiyeh Hospital
Full name of responsible person
Parya Geran malekkheyli
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Fax
+98 21 2243 9770
Email
navid.khoshbakht@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
*
Street address
*
City
*
Province
Tehran
Postal code
*
Phone
+98 21 2243 9770
Fax
+98 21 2243 9770
Email
navid.khoshbakht@gmail.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
100
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
Parya Geran Malekkheyli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran - Shahid Chamran Highway - Yemen Street - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
navid.khoshbakht@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parya Geran Malekkheyli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran - Shahid Chamran Highway - Yemen Street - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
navid.khoshbakht@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parya Geran Malekkheyli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran - Shahid Chamran Highway - Yemen Street - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
navid.khoshbakht@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
*
When the data will become available and for how long
*
To whom data/document is available
*
Under which criteria data/document could be used
*
From where data/document is obtainable
*
What processes are involved for a request to access data/document