The goal of successful embryo transfer is to transfer the atheroma of the embryos to a suitable location in the uterus, where there is the highest rate of implantation. It has been suggested that embryo transfer to the lower parts of the uterus cavity relative to the upper parts may increase the rate of implantation and pregnancy. This prospective study examines the effect of insertion of embryos on the uterus cavity on the implantation and post-pregnancy pregnancy. The fetus is evaluated under the guidance of abdominal ultrasound at a distance of 15 ± 5 mm and 25 ± 5 mm.
Design
Two arm parallel group randomized trial with blinded postoperative care and outcome assessment.Sample size was determined based on the formula, ninety samples were determined in each group
Settings and conduct
Research and Clinical Center for Infertility, Yazd
Participants/Inclusion and exclusion criteria
Among 20-39 years old participants with male factor, tubal factor, ovarian factor, unexplained or endometriosis will included. grade 3&4 endometriosis, and other protocol of ovarian stimulation were excluded.
Intervention groups
Group I 15 ±5 mm and group II 25± 5 mm distance between catheter tip and the Fundal endometrial surface
Main outcome variables
Patient age
Infertility duration
Infertility etiology
Groups
Chemical pregnancy
Clinical pregnancy
Implantation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190312043035N1
Registration date:2019-04-19, 1398/01/30
Registration timing:retrospective
Last update:2019-04-19, 1398/01/30
Update count:0
Registration date
2019-04-19, 1398/01/30
Registrant information
Name
seyedeh mahsa poormoosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 9752
Email address
poormosavi.m@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-03-31, 1392/01/11
Expected recruitment end date
2015-04-01, 1394/01/12
Actual recruitment start date
2013-05-15, 1392/02/25
Actual recruitment end date
2015-07-23, 1394/05/01
Trial completion date
2015-11-01, 1394/08/10
Scientific title
Effect of embryo transfer depth on IVF/ICSI outcome
Public title
Embryo transfer depth in endometrium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-39 years old participants
Male factor,tubal factor,ovarian factor,mix factor,unexplained,endometriosis
Women undergoing IVF/ICSI cycles
Exclusion criteria:
Other protocol of ovarian stimulation
Grade 3&4 endometriosis
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Actual sample size reached:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided on the day of the embryo transfer according to the random numbers table
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is not aware of the depths of fetus being abandoned in the uterus.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Bouali Ave., Safaeyeh, Yazd
City
yazd
Province
Yazd
Postal code
6461643981
Approval date
2012-03-15, 1390/12/25
Ethics committee reference number
3772
Health conditions studied
1
Description of health condition studied
Effect of embryo transfer depth on IVF/ICSI outcome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Results of fertility assisted methods (pregnancy test result)
Timepoint
Two weeks after the intervention
Method of measurement
Hormone measurements, ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The catheter is placed approximately 1 to 2 cm from the fundus of the uterus in the first group.
Category
N/A
2
Description
Intervention group: The catheter is positioned approximately 2 to 3 cm from the fundus of the uterus in the second group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute for Reproductive Sciences
Full name of responsible person
Seyedeh Mahsa Poormoosavi
Street address
Bouali Ave., Safaeyeh
City
Yazd
Province
Yazd
Postal code
6461643981
Phone
+98 61 4242 9752
Email
m.poormoosavi@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Yazd
Full name of responsible person
Mohammad Ali Khalili
Street address
Bouali Ave., Safaeyeh
City
yazd
Province
Yazd
Postal code
6461643981
Phone
+98 61 4242 9752
Email
Sjanati@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Yazd
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
Dezfoul University of Medical Sciences
Full name of responsible person
Seyedeh Mahsa Poormoosvi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Embryology
Street address
Dezful University of Medical Sciences, Dezful- Andymeshk Road,
City
Dezful
Province
Khouzestan
Postal code
6461643981
Phone
+98 61 4242 9752
Email
m.poormoosavi@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
sima janati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Infertility
Street address
Research and Clinical Center for Infertility, Dezful- Andymeshk Road, Ganjavian Hospital
City
Dezful
Province
Khouzestan
Postal code
6461643981
Phone
+98 61 4242 9080
Email
sjanati@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Seyedeh Mahsa Poormoosavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
,Dezful university of medical scince,histology departmentDezful- Andymeshk Road
City
Dezful
Province
Khouzestan
Postal code
6461643981
Phone
+98 61 4242 9752
Email
m.poormoosavi@ymail.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