Evaluation the effect of granulocyte colony stimulating factor in infertile woman with unexplained infertility
Design
This study is a randomized clinical trial that will be performed on 126 women with unexplained infertility in infertility clinic of Yasouj University of Medical Sciences during 2018-2019.
Settings and conduct
All patients eligible for inclusion in the study are treated with letrozole tablets and manotropin injection during the IUI cycle. After ovulation induction on the eleventh day of the menstrual cycle, transvaginal sonography is performed to examine the growth and size of the follicles. In the event of one or two follicles with a size greater than 18 mm, the same day in both groups, injection of HCG ampule are done, and IUI is administered in both groups 36 hours after injection of HCG ampule. Two days after performing IUI in the intervention group, a recombinant human granulocyte colony stimulating factor (GCSF) (300 micrograms) injection is injected subcutaneously. After two weeks from the date of the IUI, patients will be screened for the BHCG test of pregnancy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Unexplained infertility, Endometrial thickness more than 6 mm.
Exclusion criteria:Lack of follow-up, Unwillingness to participate in the study, Infertility duration more than 5 year, Age >35 year, Blocked fallopian tubes, Having endocrine disorders, Acquired and congenital uterus anomalies
Intervention groups
Administration of granulocyte colony stimulatory factor (300 μg) subcutaneously two days after IUI in comparison with no reception of granulocyte colony stimulus factor
Main outcome variables
Fertility rate
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20160524028038N4
Registration date:2019-06-03, 1398/03/13
Registration timing:registered_while_recruiting
Last update:2019-06-03, 1398/03/13
Update count:0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of granulocyte colony stimulating factor on fertility rate in infertile woman with unexplained infertility
Public title
Granulocyte colony stimulating factor on fertility rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unexplained infertility
Endometrial thickness more than 6 mm
Age between 15-37 year
Exclusion criteria:
Lack of follow-up
Unwillingness to participate in the study
Infertility duration more than 5 year
Blocked fallopian tubes
Having endocrine disorders
Acquired and congenital uterus anomalies
Age
From 15 years old to 37 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The sealed envelopes were used.
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
Ethics committee of Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2018-12-08, 1397/09/17
Ethics committee reference number
IR.YUMS.REC.1397.122
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Fertility rate
Timepoint
After two weeks from the date of the IUI
Method of measurement
BHCG test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Administration of granulocyte colony stimulatory factor (300 μg) subcutaneously two days after IUI in comparison with no reception of granulocyte colony stimulus factor
Category
Treatment - Drugs
2
Description
Control group: No receipt of granulocyte colony stimulating factor
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Fateneh Najafi
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
fataneh.najafi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari-Oriad
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
fataneh.najafi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fataneh Najafi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
fataneh.najafi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fateneh Najafi
Position
Studnet
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
fataneh.najafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fateneh Najafi
Position
Studnet
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
fataneh.najafi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD