The aim of this study is to evaluate the effect of endometrial local injury and GnRH agonist on pregnancy rate in patients with recurrent implantation failure. In a randomized uni-central clinical trial, 67 patients with recurrent implantation failure referring to infertility clinic of Alzahra Hospital, Tabriz, Iran, will be randomly assigned to receive GnRH protocol or GnRH protocol together with endometrial trauma in control or trauma group, respectively. The main inclusion criterion is to have a history of two or more implantation failure in in-vitro fertilization and the main exclusion criterion is occurrence of intolerable adverse effects. Patients in trauma group will receive endometrial trauma using pipelle biopsy in day 19th of the menstrual period and 500µg of superfact subcutaneously in day 21st of the menstrual period for both groups in order to stimulate the ovulation. Routine in vitro fertilization then will be performed for both groups and after embryo transfer pregnancy rate will be compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072412146N2
Registration date:2013-08-03, 1392/05/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-03, 1392/05/12
Registrant information
Name
Laaya Farzadi
Name of organization / entity
Woman's Reproductive Health Research Center of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
farzadl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-10, 1391/10/21
Expected recruitment end date
2013-07-12, 1392/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endometrial local injury and GnRH agonist on pregnancy rate in patients with recurrent implantation failure
Public title
Combination of trauma and drug as a treatment for implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with two or more implantation failure in IVF; to be 18 to 40 years old; not to suffer from any systemic disease such as diabetes, hypertension, etc.)
Exclusion criterion: occurrence of intolerable adverse effects.
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:
76
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Sq.
City
Tabriz
Postal code
Approval date
2013-01-08, 1391/10/19
Ethics committee reference number
91217
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy
Timepoint
10 days after in vitro fertilization
Method of measurement
Sending blood sample to laboratory to measure Beta HCG level
Secondary outcomes
empty
Intervention groups
1
Description
For intervention group: A pipelle biopsy to cause endometrial trauma in the day 19th will be performed and superfact 500µg subcutaneously in the day 21st of the menstrual period will be administered and then routine in vitro fertilization will be performed.
Category
Treatment - Other
2
Description
For control group superfact 500µg subcutaneously will be administered in day 21st of the menstrual period and then routine in vitro fertilization will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility clinic of Alzahra Hospital
Full name of responsible person
Arefe Fakour
Street address
Alzahra Hospital, Baghshomal Sq.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
AliReza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Arefe Fakour
Position
Resident of Gynecology and Obstetrics
Other areas of specialty/work
Street address
Alzahra Hodpital, Baghshomal Sq.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
a.Fakour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Laya Farzadi
Position
Assistant professor of Obstetrics
Other areas of specialty/work
Street address
Alzahra Hospital, Baghshomal Sq.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
farzadl@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Hemmati
Position
General physician
Other areas of specialty/work
Street address
Emam Reza Hospital, Daneshgah Ave.
City
Tabriz
Postal code
Phone
+98 41 1658 4305
Fax
Email
mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)