The efficacy of systemic administration of Granulocyte Colony Stimulating factor (GCSF) in patients with repeated In Vitro Fertilization (IVF) failure, a randomized controlled trial
Objectives: The aim of this study is to evaluate the efficacy of systemic subcutaneous GCSF administration on IVF success, implantation, and pregnancy rates, in infertile women with repeated IVF failure.
Design: multi-centric, prospective, randomized, open label, controlled, trial
Inclusion: infertile women who had ≥ 2 implantation failure after IVF cycles.
Exclusion: any systemic illness and having thin (-7mm) endometrium.
Sample Size: 100 infertile women
The Intervention: GnRH agonist 0.1mg will be administered subcutaneously once/day starting from 7 days before the next expected period until the third day of the cycle. Then daily subcutaneous injection of 300 IU FSH will be applied for 4 days beginning from the third day of the cycle. On the 6th day of the cycle 150 – 300 IU intramuscular injection of hMG will be administered. Transvaginal sonography will be performed every 1-3 days to evaluate the size of the follicles. When at least 2 follicles reached a minimum of 18 mm diameter 10,000 IU intramuscular injection of hCG would be applied. The participants receive 5mg Prednisolone daily starting from the day of hCG injection until three days following oocyte pickup. Transvaginal oocyte pickup will be performed 36 hours after hCG administration. 1-3 good embryos will be transferred into the uterine cavity. The participants will randomly be allocated in 2 groups. In the intervention group a single dose 300 µg GCSF will be administered subcutaneously one hour before the embryo transfer. Luteal phase support will be carried out using Cyclogest suppository 2 times/day and 80 mg Aspirin daily. Two weeks after the embryo transfer serum β-HCG level is measured for all the participants. Four and six weeks after embryo transfer transvaginal sonography will be performed.
The outcomes: chemical pregnancy, clinical pregnancy and implantation rates. The outcomes will be assessed based on positive serum β-HCG test and detecting gestational sac and fetal heart on ultrasound examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503119568N11
Registration date:2015-03-26, 1394/01/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Golnaz Rezaeizadeh
Name of organization / entity
Maternal Fetal Neonatal Research Center,Tehran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
mfnhrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Research Deputy of the Tehran University of Medical Sciences
Expected recruitment start date
2015-03-30, 1394/01/10
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of systemic administration of Granulocyte Colony Stimulating factor (GCSF) in patients with repeated In Vitro Fertilization (IVF) failure, a randomized controlled trial
Public title
the effect of systemic GCSF administration in infertile women with repeated IVF failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1. age < 40 years
2. having ≥ 2 failed IVF attempts where at least 3 good embryos were transferred
3. the lack of contraindications for GCSF treatment (sickle cell disease, chronic neutropenia, known past or present malignancy, renal insufficiency, upper respiratory infection, pneumonia, and congenital fructose intolerance)
4. not having any systemic disease
Exclusion Criteria:
1. having inadequate thin endometrium (< 7mm) on the day of hCG injection
2. the detection of Asherman’s syndrome, fibroids, and polyps in diagnostic hysteroscopy
3. having any medical illness upon enrollment (including hypertension, diabetes, antiphospholipid syndrome, systemic lupus erythematosus, thrombophilia, thyroid disorders)
4. refusing to give an informed consent to participate in the study.
Age
From 18 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
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
Research Deputy and Ethics Committee of the Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-04-07, 1392/01/18
Ethics committee reference number
10010317
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
inability to achieve a pregnancy
Primary outcomes
1
Description
chemical pregnancy
Timepoint
2 weeks after IVF and embryo transfer
Method of measurement
serum β-HCG level
Secondary outcomes
1
Description
Implantation
Timepoint
4 weeks after IVF and embryo transfer
Method of measurement
transvaginal sonography to detect gestational sacs
2
Description
Clinical Pregnancy
Timepoint
6 weeks after embryo transfer
Method of measurement
detection of gestational sac and fetal heart rate on transvaginal sonography
Intervention groups
1
Description
The Control group:
The participants in the control group do not receive any additional treatment before embryo transfer.
Category
Treatment - Drugs
2
Description
The Intervention group:
The participants in the intervention group receive a single dose of 300 µgr GCSF subcutaneously one hour before the embryo transfer process.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Department, Shariati Hospital
Full name of responsible person
Dr. Mahdi Sheikh
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Infertility Department, Bahman Hospital
Full name of responsible person
Dr. Zhila Abediasl
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Omid Infertility Clinic
Full name of responsible person
Dr. Ashraf Aleyasin
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy, Tehran University of Medical Sciences
Full name of responsible person
Dr. Atefeh Nazari
Street address
Tehran University of Medical Sciences, Enghelab street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Tehran 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
Maternal Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Sheikh
Position
M.D, Ph.D
Other areas of specialty/work
Street address
Maternal, Fetal and Neonatal Research Center, Vali-asr Hospital, Imam Khomeini Hospital complexes, Keshavarz blvd
City
Tehran
Postal code
Phone
+98 912 848 1663
Fax
Email
mahdisheikh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Infertility, Shariati Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr. Zhila Abediasl
Position
M.D
Other areas of specialty/work
Street address
Department of Infertility, Bahman Hospital, Saadat Abad
City
Tehran
Postal code
Phone
+98 912 347 1504
Fax
Email
jabediasl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Maternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi Sheikh
Position
M.D, Ph.D
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 912 848 1663
Fax
Email
mahdisheikh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)