The main of this study is to Impact of intrauterine injection of G-csf on implantation and clinical pregnancy rate in repeated implantation failure. In a randomized unit-central clinical trial, 68 patients with recurrent implantation failure referring to infertility clinic of Alzahra Hospital, Tabriz, Iran, will be randomly assigned to two groups’ case and control. The main inclusion criterion is to have a history of two or more implantation failure in in-vitro fertilization and age between 18 to 45 years and the main exclusion criterion is occurrence of intolerable adverse effects. Endometrial preparation starts with the Estradiol valerate 4 mg tablet once a day and after three days to 6 mg per day increases. Endometrial thickness is determined by ultrasound after 7 days. progesterone injections administered at a dose of 100 mg daily in achieving endometrial thickness of 8 mm. 8-cell embryo transfer after 3 days and 5 days after blastocyst transfer is done. Before progesterone injection in study group 100 micrograms G-CSF with IUI catheter as infusion intrauterine. Three days after the injection of progesterone transferred embryo transfer with a special catheter with abdominal ultrasound . 100 mg daily intramuscular progesterone for luteal phase support continues. in the patients who are FRESH embryo injected GCS-F 100 mcg with HCG by IUI catheter. BHCG test two weeks after embryo transfer is requested. Vaginal ultrasound done 3 weeks after embryo transfer, if it is positive BHCG. In this study, the primary outcome of successful implantation and clinical pregnancy is considered to be a secondary consequence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042312146N6
Registration date:2015-04-28, 1394/02/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-28, 1394/02/08
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
2015-05-05, 1394/02/15
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of intrauterine injection of G-csf on implantation and clinical pregnancy rate in repeated implantation failure
Public title
Impact of intrauterine injection of G-csf on implantation and clinical pregnancy rate in repeated implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 45-18 , and personal satisfaction; Had two or more failures of implantation
Exclusion criteria: patients with a history of uterine surgery; hydrosalpinges; endometriosis; Endometrial polyps; Submucosal myoma; Contraindications G-CSF as:Kidney failure; Chronic Neutropenia;anemia; Cancer; Pneumonia.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
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
Tabriz University of Medical Sciences
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
TBZMED.REC.1394.14
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Primary outcomes
1
Description
Implantation rates
Timepoint
Two weeks after embryo transfer
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Two weeks after positive BHCG
Method of measurement
Vaginal ultrasound
Intervention groups
1
Description
In the control group: Endometrial preparation starts with the Estradiol valerate 4 mg tablet once a day and after three days to 6 mg per day increases. Endometrial thickness is determined by ultrasound after 7 days. progesterone injections administered at a dose of 100 mg daily in achieving endometrial thickness of 8 mm. 8-cell embryo transfer after 3 days and 5 days after blastocyst transfer is done.
Category
Treatment - Drugs
2
Description
In the case group: Before progesterone injection in study group 100 micrograms G-CSF with IUI catheter as infusion intrauterine. Three days after the injection of progesterone transferred embryo transfer with a special catheter with abdominal ultrasound . 100 mg daily intramuscular progesterone for luteal phase support continues. in the patients who are FRESH embryo injected GCS-F 100 mcg with HCG by IUI catheter
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Farzadi Laya
Street address
Alzahra Hospital, South Artesh Ave
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
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
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
Dr.Farzadi Laaya
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
farzadl@yahoo.com; lahroudin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
ِDr.Farzadi Laaya
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
farzadl@yahoo.com; lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Farzadi Laeya
Position
Fellowship of Infertility
Other areas of specialty/work
Street address
Golgasht Street ,Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
farzadl@yahoo.com; lahroudin@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)