Objectives: evaluating the effect of intrauterine infusion of G-CSF on pregnancy rate. study groups is infertile patients. study phase 2. sample size is 100. blinding: not blinded. randomized controlled, single center. Setting and conduct: after obtained consent informed patients randomized in two groups. in control group usual IVF and embryo transfer will be performed. In intervention group G-CSF injected in uterine cavity. major eligibility criteria: infertile patients that candidate for IVF. Exclusion criteria: women older than 40 years, women with history of endocrine disorder, intrauterine abnormality, contraindication for use of G-CSF. Intervention: injection of 300 microgram G-CSF in uterine cavity with IUI catheter in oocyte retrieval day. primary outcome chemical pregnancy and secondary outcome clinical pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508236420N13
Registration date:2015-11-07, 1394/08/16
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-11-07, 1394/08/16
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of granulocyte colony stimulating factor (G-CSF) on IVF outcome and pregnancy rates.
Public title
Effect of granulocyte colony stimulating factor in ART treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infertile patients that candidate for IVF. Exclusion criteria: history of endocrine disorder; intrauterine abnormality; uterine polyp; submucosal fibroma; intrauterine adhesions; endometriosis; contraindication for use of G-CSF; women older than 40 years.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
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
randomization with enveloped pocket method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Science
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
yazd
Postal code
8916877391
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
444
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
serum βhCG
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
3 weeks after positive serum βhCG
Method of measurement
vaginal ultrosonography
Intervention groups
1
Description
In intervention group in oocyte retrieval day, 300 microgram G-CSF ampoul infused in endometrial cavity with IUI catheter immediately after retrieval.
Category
Treatment - Drugs
2
Description
in control group (50 patients) G-CSF not infused in endometrial cavity.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr.Maryam eftekhar, Associated Professor of Shahid Sadoughi University of medical science
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Abass Aflatounian
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
yazd
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 Shahid Sadoughi 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
Sadoughi University of Medical Science ,Yazd
Full name of responsible person
Maryam Eftekhar
Position
Associated Professor
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
eftekharmaryam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sadoughi University of Medical Science
Full name of responsible person
Maryam Eftekhar
Position
Associated Professor
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
eftekharmaryam@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sadoughi University of Medical Science
Full name of responsible person
Maryam Eftekhar
Position
Associated professor
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
eftekharmaryam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)