We are going to study on efficacy of intrauterine G_CSF in implantation in patients with recurrent pregnancy loss. In this prospective randomized trial we are going to investigate efficacy of intrauterine G-CSF(300 micrograms or 1ml) in Avicenna research center patients’ with recurrent pregnancy loss. Patients will be divided to two groups; A: patients will be administrated intrauterine G-CSF twice(first when intra vaginal ultrasound revealed adequate follicle and then 1 week after HCG administration).These two groups will be compared about pregnancy outcomes. All groups will be administrated Heparin and Aspirin experimentally.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012211430N3
Registration date:2013-04-17, 1392/01/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-17, 1392/01/28
Registrant information
Name
Simin Zafardoust
Name of organization / entity
Jahad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 4701
Email address
s.zafardoost@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahad of University
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Granulocyte Colony Stimulating Factor(G-CF) on treatment of unexplained recurrent miscarriage in Avicena center
Public title
Treatment of patients with recurrent pregnancy loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with 3 or more abortion or 2 consecutive abortion; under 40 years old; normal karyotype; normal uterus; without infectious or immunologic or endocrine or thrombotic disorders; normal thyroid function,TPO<=500; FSH<=10; LH=normal and FBS=normal.
Exclusion criteria: cancer and no acceptance to participate in the study.
Age
To 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
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
Jahad center of university
Street address
Shahid Beheshty university
City
Tehran
Postal code
19419113194
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
91/س/15/2824
Health conditions studied
1
Description of health condition studied
Recurrent pregnancy loss
ICD-10 code
N96
ICD-10 code description
Habitual aborter
Primary outcomes
1
Description
Abortion rate
Timepoint
14 days after intervention- 3 months after intervention and 9 months after intervention
Method of measurement
Laboratory-ultrasonography
Secondary outcomes
1
Description
Natural Killer cells
Timepoint
14 days after HCG
Method of measurement
Measurment of CD16-CD56
Intervention groups
1
Description
Intra uterin infusion of G-CSF when follicle size is appropriate and 1 week after HCG
Category
Treatment - Drugs
2
Description
Routin care; we have no intervention in control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and recurrent pregnancy loss center of Avecinna
Full name of responsible person
Dr Ansaripoor Soheila- Dr Zafardoost Simin
Street address
Shriati-Yakhchal
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reaserch center of Avicenna
Full name of responsible person
Dr Akhoondi Mohammad Mehdi
Street address
Yakhchal, Shariati
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reaserch center of Avicenna
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
Infertility and recurrent pregnancy loss center of Avicenna
Full name of responsible person
Dr Zafardoost Simin
Position
Obstetrics and Gynecologist-fellowship in infertility