The Effect of Intrauterine Injection of Granulocyte Stimulant Factor on the Success of Intrauterine Sperm insemination in Patients Referred to Infertility Center of Ardabil University of Medical Sciences
The Effect of Intrauterine Injection of Granulocyte Stimulant Factor on the Success of Intrauterine Sperm insemination
Design
In this interventional study, 40 infertile women who met the inclusion criteria will be selected and divided into two groups using block randomization method (n=20in each group). Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen.
Settings and conduct
Both intervention and control groups will receive clomiphene (50 mg, daily, manufactured by Iran Hormone Pharmaceutical Company) from 3 to 7 days for 5 days. On the ninth day, an ultrasound will be performed. If the follicle is greater than or equal to 20 mm, in Fourteenth day 5,000 units of HCG (manufactured by Ronak Daru) will be given intramuscularly and will be administered IUI 36 hours later. In the intervention group, in addition to the previous actions on the day of IUI injection, 100 µg of G-CSF (Recpharma product) will be injected with the IUI catheter.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertility. Exclusion criteria: Endometriosis، Uterine Surgery History.
Intervention groups
Intervention group: Intrauterine injection of 100 μg G-CSF (Recpharma Co. product) and 36 hours later IUI. Control group: Perform IUI without intrauterine G-CSF injection.
Main outcome variables
Pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191122045466N1
Registration date:2019-12-18, 1398/09/27
Registration timing:prospective
Last update:2019-12-18, 1398/09/27
Update count:0
Registration date
2019-12-18, 1398/09/27
Registrant information
Name
elham mostafavi rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 2232
Email address
e.mostafavirad@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Intrauterine Injection of Granulocyte Stimulant Factor on the Success of Intrauterine Sperm insemination in Patients Referred to Infertility Center of Ardabil University of Medical Sciences
Public title
The Effect of Intrauterine Injection of Granulocyte Stimulant Factor on the Success of Intrauterine Sperm insemination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility
Exclusion criteria:
Endometriosis
Uterine Surgery History
Age
To 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned randomly by blocking in one of the two specified groups and after selecting the envelope for each patient, before starting the treatment regimen envelope will be opened and based on the protocol, one of two methods will be selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are not aware of the type of medication
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
ARDABIL
Province
Ardabil
Postal code
5615783134
Approval date
2019-08-29, 1398/06/07
Ethics committee reference number
1398.286.IR.ARUMS.REC
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy
Timepoint
3 weeks after intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Human chorionic gonadotropin hormone
Timepoint
Two weeks after intervention
Method of measurement
Laboratory
Intervention groups
1
Description
Intervention group: Intrauterine injection of 100 μg G-CSF (Recpharma product) during IUI
Category
Treatment - Drugs
2
Description
Control group: Perform IUI without intrauterine G-CSF injection
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Elham Mostafavirad
Street address
Alavi Hospital, Moadi street, Ardabil
City
ARDABIL
Province
Ardabil
Postal code
5615783134
Phone
+98 45 4233 8888
Email
e.mostafavirad@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahab.bohlooli
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
ARDABIL
Province
Ardabil
Postal code
5615783134
Phone
+98 45 3352 2247
Email
s.bohlooli@pharmacy.arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Elham Mostafavirad
Position
Gynecology Asisstant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 3324 8888
Email
e.mostafavirad@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Fariba Kahnamoee Agdam
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 3324 8888
Email
f.kahnamuee.a@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Elham Mostafavirad
Position
Gynecology Asisstant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 3324 8888
Email
e.mostafavirad@arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available