Effects of Intrauterine Injection of Granulocyte Colony-Stimulating Factor (G-CSF) on Pregnancy Rate of Infertile Women Undergoing Intrauterine Insemination (IUI)
(1) Objectives: The aim of the current study is to determine the effects of intrauterine granulocyte colony-stimulating factor on pregnancy outcome of those undergoing intrauterine insemination (IUI).
(2) Design: Randomized, double-blind, placebo-controlled clinical trial.
(3) Setting and conduct: Tertiary reproductive health care center
(4) Participants including major eligibility criteria: A total number of 200 infertile women between 20 and 40 years of age will be included. We will exclude those with reactions to prostaglandins and comorbidities such and liver and renal failure.
(5) Intervention: All the patients will randomly be assigned to received intrauterine injection of G-CSF (n=100) or normal saline as placebo (n=100) at the day of HCG injection. The ovarian stimulation and IUI protocols will be the same in two groups.
(6) Main outcome measures (variables): The endometrial thickness on the days of HCG triggering, pregnancy rate and miscarriage rate will be recorded and compared between two study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212079281N2
Registration date:2017-05-06, 1396/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-06, 1396/02/16
Registrant information
Name
Sedigheh Amooee
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 2426
Email address
amooee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2017-03-10, 1395/12/20
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Intrauterine Injection of Granulocyte Colony-Stimulating Factor (G-CSF) on Pregnancy Rate of Infertile Women Undergoing Intrauterine Insemination (IUI)
Public title
Granulocyte Colony-Stimulating Factor for Intrauterine Insemination (IUI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 40 years; unexplained infertility; candidate for intrauterine insemination (IUI)
Exclusion criteria:
Allergy to prostaglandins; medical history of liver disease or renal failure; asthma; pulmonary disorders; glaucoma; contraindication of G-CSF injection such as sickle cell anemia, neutropenia and autoimmune disorders; endometriosis; male infertility; decreased ovarian reserve; Asherman syndrome; diabetes mellitus (DM)
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:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Science
Street address
Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.SUMS.MED.REC.1395.60
Health conditions studied
1
Description of health condition studied
infertile women under mild ovary stimulation and IUI
ICD-10 code
N97
ICD-10 code description
Female Infertility
Primary outcomes
1
Description
endometrial thickness in IUI cycle under mild ovarian stimulation
Timepoint
on the day of HCG triggering
Method of measurement
Measuring endometrial thickness on the day of HCG triggering by vaginal sonography.
Secondary outcomes
1
Description
chemical and Clinical pregnancy or miscarriag
Timepoint
16 days after doing IUI
Method of measurement
Serum beta HCG and transvaginal sonography.
Intervention groups
1
Description
Clomiphene citrate 100 gr QD from 5th -9th day of cycle and gonadotropin (FSH), 50-150 unit will be added in 8th day of cycle till there is one follicle with diameter 18 mm in vaginal sonography and , granulocyte colony-stimulating factor (G-CSF) will be injected intrauterine on the day of HCG injection
Category
Treatment - Drugs
2
Description
Clomiphene citrate 100 gr QD from 5th -9th day of cycle and gonadotropin (FSH), 50-150 unit will be added in 8th day of cycle till there is one follicle with diameter 18 mm in vaginal sonography
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mother & Child Hospital
Full name of responsible person
Zahra Shomali
Street address
Mother & Child hospital, Quran gate
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz University of Medical Sciences، Zand Street
City
Shiraz
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 of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Zahra Shomali
Position
Fellowship Infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences، Zand Street
City
Shiraz
Postal code
7193635899
Phone
+98 71 3227 9715
Fax
Email
Shomaliz57@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences،
Full name of responsible person
Dr Sedigheh Amooee
Position
Fellowship Infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences، Zand Street
City
Shiraz
Postal code
7193635899
Phone
+98 71 3227 9715
Fax
Email
sedighehamooee@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Shomali
Position
Fellowship Infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences، Zand Street
City
Shiraz
Postal code
7193635899
Phone
+98 71 3227 9715
Fax
Email
Shomaliz57@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)