Objectives: To assess the systemic granulocyte-colony stimulating factor versus placebo on implantation in infertile women.
Design: a single blind randomized clinical trial.
Setting and conduct: The eligible infertile women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) being infertile; (b) age of 20 to 40 years.
Exclusion criteria: (a) contraindication of pregnancy; (b) secondary infertility due to background disease; (c) infertility because of her spouse; (d) weak response to gonadotropin.
Intervention group: Injection of granulocyte-colony stimulating factor 300 IU intramuscularly in deltoid muscle at first day and 48 hours later.
Control group: Injection of normal saline intramuscularly in deltoid muscle at first day and 48 hours later.
Primary outcome: Assessing the formation of gestational sac by transvaginal ultrasound 3 weeks after intervention.
Secondary outcome: Assessing beta human chorionic gonadotropin 10 days after intervention by laboratory test.
Randomization: Random assignment of the patients to the intervention and control groups one at a time.
Blinding: Patients will be unaware of the type of intervention, but the physician who will examine the patients will be aware of the intervention. Therefore, the trial will be run as single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511269014N85
Registration date:2015-12-05, 1394/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-05, 1394/09/14
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
2015-04-04, 1394/01/15
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of systemic granulocyte-colony stimulating factor versus placebo on implantation in infertile women: a single blind randomized clinical trial
Public title
Effect of systemic granulocyte-colony stimulating factor versus placebo on implantation in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) being infertile; (b) age of 20 to 40 years.
Exclusion criteria: (a) contraindication of pregnancy; (b) secondary infertility due to background disease; (c) infertility because of her spouse; (d) weak response to gonadotropin.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups one at a time.
Blinding: Patients will be unaware of the type of intervention, but the physician who will examine the patients will be aware of the intervention. Therefore, the trial will be run as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-11-02, 1394/08/11
Ethics committee reference number
IR.UMSHA.REC.1394.334
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Assessing the formation of gestational sac
Timepoint
3 weeks after intervention
Method of measurement
By transvaginal ultrasound
Secondary outcomes
1
Description
Assessing beta human chorionic gonadotropin
Timepoint
10 days after intervention
Method of measurement
By laboratory test
Intervention groups
1
Description
Injection of granulocyte-colony stimulating factor 300 IU intramuscularly in deltoid muscle at first day and 48 hours later
Category
Treatment - Drugs
2
Description
Injection of normal saline intramuscularly in deltoid muscle at first day and 48 hours later
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Nages Mehrabi
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 Nages Mehrabi
Position
Resident of Gynecology
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
narges.mehrabi95@gmail.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 3828 3939
Fax
Email
farimanie@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)