The aim of this study is evaluation of the effect of Granulocyte-colony stimulating factor(G-CSF) in َAssisted Reproductive Techniques outcomes in repeated implantation failures .Therefore from patients referred to Avicenna Infertility Treatment Center from 21/07/2013 until 22/10/2013 with more than 3 unexplained Assisted Reproductive Techniques failures in ages between 20 and 38 years and based on other Inclusion and Exclusion criteria totally 100 patients in Intervention group(50) and in Control group(50) will be evaluated randomly and double blind.
We use GnRH agonist(long protocol) For ovulation induction in all patients ;in Intervention group 1cc(300)microgram G-CSF and in Control group 1cc normal saline will be injected in to uterine cavity through vagina on day ovarian puncture(for oocytes collection), and Assisted Reproductive Techniques outcomes will be evaluated in two groups for pregnancy rates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013063011653N2
Registration date:2013-07-16, 1392/04/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Sara Mokhtar
Name of organization / entity
Avicenna Infertility Treatment Center
Country
Iran (Islamic Republic of)
Phone
+98 21 23519
Email address
s.mokhtar@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Infertility Treatment Center
Expected recruitment start date
2013-07-21, 1392/04/30
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
G-CSF and Assisted Reproductive Techniques outcomes in repeated implantation failures
Public title
G-CSF and Assisted Reproductive Techniques outcomes in repeated implantation failures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ART failure>3; Age:20-38; Normal karyotype and uterus anatomy; Do not have infection,endocrine and immune and coagulation disorders ,thrombophilia; Normal TSH,LH,FBS; FSH<10 TPO<500; Negative lupus anti coagulant; Negative Toxoplasma,CMV,Rhubella; Normal Factor 5leiden,factor2 prothrombin,protein C, Pr S
Exclusion criteria:Azoospermia with negative testis biopsy; Egg donation; Suffering from cancer
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Infertility Treatment Center
Street address
Avicenna Infertility Treatment Center, No 97, Yakhchal-Shariati junction, Shariati st, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-11-05, 1391/08/15
Ethics committee reference number
2823/15/ص/91
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
After intervention
Method of measurement
Gestational Sac in sonography
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
After intervention
Method of measurement
HCG
Intervention groups
1
Description
In Intervention group 1cc(300)microgram Granulocyte-colony stimulating factor will be injected in to uterine cavity through vagina.
Category
Treatment - Drugs
2
Description
In Control group 1cc normal salin will be injected in to uterine cavity through vagina.