The aim of this study, is investigating the verification of endometrial scratching in infertile women candidate for Intravitro fertilization (IVF) with history of Recurrent Implantation Failure (RIF) referring to the infertility clinic Al-zahra hospital, Rasht during the years 2015-2017. In this study single blind (patients) is 114 infertile women, which they divided into two group went under hystroscopy (conrtol group), and one group went under the endometrial scratching in four direction with curet (intervention group) in luteal phase. Including criteria; women with more than two failure in IVF; less than 40 years old; FSH≤12 and normal ultrasonography and HSG. Excluding criteria; any endometrial lesion and lack of at least two good quality embryos. Study cases then the rate of positive BHCG, successful pregnancy, multiple pregnancy, abortion and live birth are evaluating.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201708081306N9
Registration date:2017-09-12, 1396/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-12, 1396/06/21
Registrant information
Name
Ziba Zahiri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
drzibazahiri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research-Guilan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-09-13, 1397/06/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the success rate of hysteroscopy and endometrial Scratching for Intravitro fertilization in Recurrent Implantation Failure case
Public title
Investigating the success rate of endometrial Scratching in infertillty and infertility treatment Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: infertile women with more than two failure in IVF; women less than 40 years old; FSH≤12; normal ultrasonography and HSG. Excluding criteria: any endometrial lesion in hysteroscopy (myoma, polyp, aserman, mulerian anomaly); lack of at least two good quality embryos; Ovarian hyperstimulation syndrome; Progestrone>2
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
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
Ethics Committe of Guilan University of Medical Sciences
Street address
Vice Chancellor for Research-Guilan University of Medical Sciences, Gaz Squre.
City
Rasht
Postal code
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.GUMS.ERC.1396.54
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Occurring pregnancy
Timepoint
Two week after transfer
Method of measurement
BHCG≥200
Secondary outcomes
1
Description
Rate of abortion
Timepoint
Till 20 weeks pregnancy.
Method of measurement
Observation of bleeding
2
Description
Rate of multiple pregnancies
Timepoint
three weeks after positive pregnnacy test
Method of measurement
Reporting in ultrasonography
3
Description
Rate of successful pregnancy
Timepoint
Three weeks after positive pregnancy test
Method of measurement
Observation of pregnancy sac and Fetal Heart in ultrasonography
4
Description
Rate of live birth
Timepoint
After the gestational age of 20 weeks.
Method of measurement
Observation
Intervention groups
1
Description
Hysteroscopy in control group
Category
Treatment - Surgery
2
Description
Endometrial scratching (Curt drag quadrant endometrial) and hysteroscopy in intervention group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Farnoush Farzi
Street address
Alzahra hospital, Namjoo street.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research-Guilan University of Medical Sciences
Full name of responsible person
Dr.Shadman Nemati
Street address
Vice Chancellor for Research-Guilan University of Medical Sciences , Gaz Square.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research-Guilan 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
Guilan university of Medical Sciences
Full name of responsible person
Dr. Yasaman Sarafzadeh
Position
Gynecology resident
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra hospital, Namjo street.
City
Rasht
Postal code
Phone
+98 13 3336 9224
Fax
Email
Yasamansarafzadeh96@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan university of Medical Sciences
Full name of responsible person
Dr. Ziba Zahiri
Position
Professor of Obstetrics & gyencology
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra hospital, Namjo street.
City
Rasht
Postal code
Phone
+98 13 3336 9224
Fax
Email
drzibazahiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan university of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
Bachelor of Midwifery
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 3336 9224
Fax
Email
dalilheirati@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)