Effect granulocyte colony stimulation factor (GCSF) versus placebo on implantation among infertile patients who underwent assisted reproductive technology (ART): a randomzed clinical trial
Objectives: To assess the effect of GCSF versus placebo on implantation among infertile patients who underwent ART
Design: a randomized clinical trial.
Setting and conduct: The eligible infertile women who will refer to the Infertility Research Center of Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) Infertile; (b) age of 20 to 40 years; (c) having determined factor such as endometriosis, myoma, or Asherman's syndrome.
Exclusion criteria: (a) having cycle cell anemia, renal failure, upper or lower respiratory infection, or malignancy; (b) contraindication for pregnancy; (c) weak response rate.
Intervention: transvaginal injection of GCSF 300 IU, single dose, 2 or 5 days before embryo transfer plus prescription of OCP for 21 days plus 50 mcg GNRH agonist single dose on the 3rd day of menstrual period and 300 to 450 IU FSH or HMG, single dose, on the 14th day of menstrual period.
Control: prescription of OCP for 21 days plus 50 mcg GNRH agonist single dose on the 3rd day of menstrual period and 300 to 450 IU FSH or HMG, single dose, on the 14th day of menstrual period.
Primary outcome: diagnosis of gestational sac and observation of embryo by transvaginal ultrasonography 24 days after embryo transfer.
Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501049014N52
Registration date:2015-01-07, 1393/10/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-07, 1393/10/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect granulocyte colony stimulation factor (GCSF) versus placebo on implantation among infertile patients who underwent assisted reproductive technology (ART): a randomzed clinical trial
Public title
Effect granulocyte colony stimulation factor (GCSF) versus placebo on implantation among infertile patients who underwent assisted reproductive technology (ART)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) Infertile; (b) age of 20 to 40 years; (c) having determined factor such as endometriosis, myoma, or Asherman's syndrome.
Exclusion criteria: (a) having cycle cell anemia, renal failure, upper or lower respiratory infection, or malignancy; (b) contraindication for pregnancy; (c) weak response rate.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: random assignment of the patients systematically one at a time to intervention and control groups.
Blinding: Not blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
P/16/35/9/712
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
diagnosis of gestational sac and observation of embryo
Timepoint
24 days after embryo transfer
Method of measurement
by transvaginal ultrasonography
Secondary outcomes
empty
Intervention groups
1
Description
transvaginal injection of GCSF 300 IU, single dose, 2 or 5 days before embryo transfer.
Category
Treatment - Drugs
2
Description
prescription of OCP for 21 days plus 50 mcg GNRH agonist single dose on the 3rd day of menstrual period and 300 to 450 IU FSH or HMG, single dose, on the 14th day of menstrual period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Zahra yazdi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Dr Zahra yazdi
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 7459
Fax
Email
zyazdi88@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Marzieh farimani
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 7459
Fax
Email
farimanie@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)