The comparing granulocyte colony stimulating factor , intra muscular and intra uterine form on fertilization at women with idiopathic infertility in intra uterine insemination.
The comparing granulocyte colony stimulating factor(GCSF) , subcutaneous and intrauterine form on fertilization at women with idiopathic infertility in intrauterine insemination(IUI).
Design
Randomized clinical trial with control and parallel group, double blind,
Randomized, third phase , on 88 patients who divided in 4 groups of 22 Persons, randomized with a table of random numbers.
Settings and conduct
patients will randomly dividing two intervention groups of sub cutaneous and intrauterine injection of GCSF and two control group of intrauterine and sub cutaneous injection of placebo. Induction ovulation process will done and on trigger day patients will receive drug or placebo then IUI will done, after 2 weeks chemical pregnancy with lab data and after 4 weeks clinical pregnancy with sonography will assist. the person who injecting and collecting data and the person who analyze the data will blind.
Participants/Inclusion and exclusion criteria
Women with unexplained infertility between 20-38 year old without anatomical pelvic problems or endometriosis or male factor infertility
Intervention groups
Group received GCSF subcutaneous
Group received GCSF intrauterine
Group received placebo subcutaneous
Group received placebo intrauterine
Main outcome variables
The main factor: endometrial thickness, chemical and clinical pregnancy will evalute.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200303046688N1
Registration date:2020-05-26, 1399/03/06
Registration timing:retrospective
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
MARYAM Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 7001
Email address
faba_1366@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-05, 1398/01/16
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
2019-04-05, 1398/01/16
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-03-18, 1398/12/28
Scientific title
The comparing granulocyte colony stimulating factor , intra muscular and intra uterine form on fertilization at women with idiopathic infertility in intra uterine insemination.
Public title
Evaluation the effect of Granulocyte Colony Stimulating Factor on infertility
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Every patients with unexplained infertility
Exclusion criteria:
Pelvic anomaly
Progressive endometriosis
Azosperm sex partner
Male factor infertility
Age
From 20 years old to 38 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Actual sample size reached:
83
Randomization (investigator's opinion)
Randomized
Randomization description
In this study patients were divided in intrvention and control groups with a table of random numbers with individual units and with simple random method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the person who injected the drug or placebo, the person who collecting data and the person who analyzing will blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of hormozgan university of medical sciences
Street address
Hormozgan university of medical sciences, shahid chamran boulivard, bandarabbas
City
bandar abas
Province
Hormozgan
Postal code
7916613885
Approval date
2020-02-26, 1398/12/07
Ethics committee reference number
IR.HUMS.REC.1398.443
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
chemical pregnancy, clinical pregnancy
Timepoint
beta hcg seum test 2 weeks after IUI, sonographic evaluation 4 weeks after IUI
Method of measurement
biochemical serum test, sonography and FHR observation
Secondary outcomes
1
Description
endometrial tickness
Timepoint
trigger day
Method of measurement
sonography
2
Description
chemical pregnancy
Timepoint
2 weeks after IUI
Method of measurement
laboratory test
3
Description
clinical pregnancy
Timepoint
4 weeks after IUI
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: sub cutaneous injection of 300 micro gram granulocyte with 0.5 milliliter in volume from Pooyesh Darou biopharmaceutical, made in iran in unique dose at trigger day
Category
Treatment - Drugs
2
Description
Intervention group: intrauterine injection of 300 micro gram granulocyte with 0.5 milliliter in volume from Pooyesh Darou biopharmaceutical, made in iran in unique dose at trigger day
Category
Treatment - Drugs
3
Description
Control group: 0.5 milliliter normal salin solution subcutaneus with unique dose on trigger day
Category
Placebo
4
Description
Control group: 0.5 milliliter normal salin solution intrauterine with unique dose on trigger day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center of Hormozgan university of medical sciences
Full name of responsible person
Dr Maryam Azizi Cutenaei
Street address
Infertility center of Hormozgan university of medical sciences, 1st floor of Shafa burn center, pyambar azam convened, Parastar avenue
City
Bandar abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
Maryamazizikut86@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hormozgan university of medical sciences
Street address
Chamran boulvard
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
mail@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi Cutenaei
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Infertility center of Hormozgan university of medical sciences, pyambar azam convined, parastar avenue, pyambar azam convined,
City
bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
Maryamazizikut86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi Cutenaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar avenue, burn center, floor 1
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
Maryamazizikut86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Maryam Azizi Cutenaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar avenue, burn center, floor 1,
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3334 7001
Email
Maryamazizikut86@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
results about fertility rate and association with BMI and endometrial thickness and ovarian reserve and injection method will participate
When the data will become available and for how long
start from winter 2020
To whom data/document is available
researchers working in educational institution
Under which criteria data/document could be used
adding up with other article
From where data/document is obtainable
dr maryam azizi, Maryamazizikut86@gmail.com
What processes are involved for a request to access data/document
The information will publish in an article at a creditable magazine after analyzing of data.