The goal of this study is to evaluate the effect of a single dose of colony stimulating factor ,granulocyte macrophage successful pregnancy in patients with pregnancy failure that is studied in this group of patients for the first time. In this study ,a group of 50 after getting testimonial was injected 300 mcg G- CSF(one dose)once on a day of embryo transfer. After 14 days pregnancy outcome will be recorded and pregnancy ,abortion rates and live birth rate will be compared with a control group of 50 patients with the (help of infertility treatment)(IVF). All patients will be treated on antagonists protocol, and pregnancy outcome will be checked afterward. the result of that will be investigated in the form of clinical pregnancy rates, abortion rates and live birth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072118381N1
Registration date:2015-01-03, 1393/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Ahmad Hosseini
Name of organization / entity
Shahid Beheshty University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 9153
Email address
ahmad-hosseini@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshty University of Medical Science
Expected recruitment start date
2014-04-19, 1393/01/30
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of single G-CSF injection on pregnancy outcome in patients with IVF failure
Public title
The effect of Granulocyte Colony-Stimulating Factor (G-CSF) on IVF failiuare
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: the patient with ivf failiuare
exclusion criteria: male factor patients
Age
No age limit
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshty University of Medical Science
Street address
velenjak, koodakyar ave, shahid beheshty medical university
City
tehran
Postal code
Approval date
2014-06-15, 1393/03/25
Ethics committee reference number
153 با توجه به اینکه در کمیته اخلاق دانشگاه تایید شده،
Health conditions studied
1
Description of health condition studied
ivf failiuare
ICD-10 code
N97
ICD-10 code description
female infertility
Primary outcomes
1
Description
ivf outcome
Timepoint
2 weeks after start of drug
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
study group: injection of 300 mg G-CSF after embryo transfer
Category
Treatment - Drugs
2
Description
control group: not injection of G- CSF after embryo transfer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Givar
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshty University of Medical Science
Full name of responsible person
Dr. Zarghi
Street address
Cellular & Mollecular Biology Research Center, Shahid Beheshty Medical University, Koodakyar Ave, Daneshjoo Blv, Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshty University of Medical Science
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
Shahid Beheshty Medical University
Full name of responsible person
Fattaneh Farifteh
Position
phd
Other areas of specialty/work
Street address
Cellular & Mollecular Biology Research Center, Shahid Beheshty Medical University, Koodakyar Ave, Daneshjoo Blv, Velenjak
City
Tehran
Postal code
Phone
+98 21 2235 9154
Fax
Email
f.farifteh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gثenetics & In Vitro Assisted Reproduction (GIVAR) Center, Erfan Hospital
Full name of responsible person
Seyyede Soheila Arefi
Position
Infertility Specialist
Other areas of specialty/work
Street address
Erfan Hospital, Bakhshayesh St., Saadat Abad
City
Tehran
Postal code
Phone
+98 21 2235 9153
Fax
Email
soheilaarefi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Fattaneh Farifteh
Position
PhD
Other areas of specialty/work
Street address
Cellular & Mollecular Biology Research Center, Shahid Beheshty Medical University, Koodakyar Ave, Daneshjoo Blv, Velenjak
City
Tehran
Postal code
0098
Phone
+98 21 2235 9153
Fax
+98 21 2235 9152
Email
f.farifteh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)