Objectives: evaluating the effect of intrauterine infusion of Granulocyte colony-stimulating factor (G-CSF) on improvement endometrial thickness and improvement implantation rate and increasing pregnancy rate after transferring frozen embryo transfer in infertile women. Blinding: not blinding. Randomization: non-randomized. Study population : selecting 80 patients of infertile women admitting to infertile center of Ghadir child and mother hospital in shiraz after obtained informed consent and dividing them into two groups of 40 women ( one group has women with endometrial thickness more than 6 mm as a control group, another group has women with endometrial thickness less than 6 mm as an intervention group). Inclusion criteria : Infertile women - Age between 20-45 - Patients are receiving estradiol valerate - women with endometrial thickness more than 6 mm and women with endometrial thickness less than 6 mm. Exclusion criteria: Presence of Granulocyte colony-stimulating factor (G-CSF) contra-indications including past history and presence of malignancy - History of uterine surgery - Renal failure - Azoospermia in patient's husband - Diabetes. Intervention : intrauterine injection of 300 microgram Granulocyte colony-stimulating factor (G-CSF) in tenth day of hormone replacement therapy (HRT cycle). Primary outcome : endometrial thickness. Secondary outcomes : implantation rate and clinical pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030722206N3
Registration date:2017-05-01, 1396/02/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Alamtaj Samsami
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 9715
Email address
samsamia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research of Shiraz University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intrauterine infusion of Granulocyte Colony-Stimulating Factor (G-CSF) on endometrial thickness in frozen embryo transfer
Public title
The effect of Granulocyte Colony-Stimulating Factor (G-CSF) on endometrial thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women, Age between 20-45, women are receiving conventional treatment: estradiol valerate , women with normal endometrial thickness (more than 6 mm) for control group and women with endometrial thickness less than 6 mm for intervention group
Exclusion criteria: Presence of Granulocyte colony, stimulating factor (G-CSF) contra-indications including: Sickle cell anemia, Chronic neutropenia, Past history of malignancy, Presence of malignancy, Upper respiratory infections, History of uterine surgery, Renal failure, Azoospermia in patient's husband, Pneumonia, Congenital fructose intolerance, Thyroid diseases , Diabetes, Asherman syndrome
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.SUMS.MED.REC.1395.04
Health conditions studied
1
Description of health condition studied
Infertility and treatment methods
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Endometrial thickness
Timepoint
Before intervention and 72 hours after intervention
Method of measurement
Transvaginal sonography
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
3 weeks after positive serum βhCG
Method of measurement
Vaginal ultrosonography
2
Description
Implantation rate
Timepoint
14 days after embryo transfer
Method of measurement
Measurement of serum βhCG
Intervention groups
1
Description
Intervention group : intrauterine injection of 300 microgram Granulocyte colony-stimulating factor (G-CSF) in tenth day of hormone replacement therapy (HRT cycle)
Category
Treatment - Drugs
2
Description
Control group: not intrauterine injection of Granulocyte colony-stimulating factor (G-CSF), prescription of Estradiol valerate from second day of menstrual cycle and increasing dose (2 mg, every 4)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother & Child hospital
Full name of responsible person
Shima Talebi
Street address
Shiraz University of Medical Sciences, Zand Street
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, Shiraz
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. Shima Talebi
Position
Rezedent of Obstetrics & GYN
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, zand street
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
stud2480307603@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr.Alamtaj Samsami
Position
Professor of Obstetrics & GYN, Fellowship Infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
samsamia@sums.ac.irhafez_perina@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
DR.Alamtaj Samsami
Position
Professor of Obstetrics & GYN, Fellowship Infertility
Other areas of specialty/work
Street address
Shiraz University of Medical Science, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 2365
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)