The aim of this study is the local endometrial injury in patients with the history of repeated ivf failure to increase fetal implantation . 120 patients with inclusion criteria like age more than 40,RIF,minimum of 4 good fetuses .normal uterus,minimum endometrial thickness of 6 millimeter on HCG administration by simple randomization were involved our study. both group(case & control) were advised to come to our clinic on 21th day of the cycle before IVE& were divided in two 60 group of case & control.in case group endometrial injury by pipple was done&super fact(30 unit=3cc subcutaneous) was started in both & come back on 3th day of next cycle& estradiol was started for both group(6mg daily)&increase of dose to 8 milligram .one weak later sono was done & if endometrial thickness is 8mm , progesterone was started(400microgram by two daily )&3 days later, Embryo transfer was done.clinical pregnancy rate,implantation rate,EP&abortion were the outcome that were surveyed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311065181N12
Registration date:2015-10-20, 1394/07/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-20, 1394/07/28
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
C
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment effect of endometrial injury on rate of successful pregnancy outcomes in infertile patients .
Public title
Assessmen effect of endometrial injury on successful rate of repeated failure of FET
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age lower than 40 years ,minimum of 4 good fetuses ; minimum of 2 cycle of failure; Endometrial thickness on day of progesterone administration more than 8mm.
Exclusion criteria :submucosal myoma larger than 3 centimeter , intramural-subserosal myoma larger than 5 Cm ,endometrioma larger than 3 centimeter ,systemic disease ,Tuberculosis , ,hydrosalpinx+bilateral tubal obstruction,asherman syndrome.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics Committee of Tehran University of Medical Sciences
Street address
.Medical faculty of Tehran University of Medical Sciences,Ghods street,keshavarz blv
City
Tehran
Postal code
14194
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
2244
Health conditions studied
1
Description of health condition studied
femail infertility
ICD-10 code
N.97
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
2 weak after trasfer
Method of measurement
Blood sample
2
Description
Frozen Embryo Transfer
Timepoint
2 weak post trasfer
Method of measurement
Transvaginal sonography
Secondary outcomes
1
Description
Abortion
Timepoint
2 weaks post transfer
Method of measurement
Transvaginal sonography
2
Description
ectopic pregnancy
Timepoint
2 weaks post transfer
Method of measurement
trasvaginal sonography&blood sample
3
Description
implantation rate
Timepoint
2 weaks post transfer
Method of measurement
sonography
Intervention groups
1
Description
intervention group: endometrial injury by pipple was done in the 21 th of mensturation cycle &superfact(30 unit=3cc subcutaneous) was started & come back on 3th day of next cycle& estradiol was started for both group(6mg daily)&increase of doseto 8 miligram .one weak later sono was done & if endometrial thickness is 8 milimetre, progestron was started(400microgram by two times daily )&3 days later Embryo transfer was done.
Category
Treatment - Other
2
Description
controll group:endometrial injury by pipple was not done&superfact(30 unit=3cc subcutaneous) was started in both & come back on 3th day of next cycle& estradiol was started for both group(6mg daily)&increase to 8 miligram .one weak laterr sono was done & if endometrial thickness was 8mm, progestron was started(400microgram by two times daily )&3 days later Embryo transfer was done.