In this double blind controlled trial study,80 women that had 4 good quality embryo after thawing in Avicenna center were included.these patients was divided to two group by randomization. we will study beta-HCG level,implantation and clinical pregnancy rates ,abortion under 12 weeks,multiple pregnancy , embryo qualities before ET and blastocyst outgrowth in 2 groups.In intervention group embryos after thawing will cultured in embryo culture whit GM-CSF (Embryogen) and in another group embryos will cultured in G2 medium(Vitrolife) without GM-CSF.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021611430N4
Registration date:2014-03-17, 1392/12/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-17, 1392/12/26
Registrant information
Name
Simin Zafardoust
Name of organization / entity
Jahad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 4701
Email address
s.zafardoost@avicenna.ac.ir
Recruitment status
Recruitment complete
Funding source
Infertility and recurrent abortion treatment center of avicenna
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of GM-CSF in embryo culture for freezed embryos in embryo development and pregnancy outcomes
Public title
Efficacy of embryo culture on freezed embryos and pregnancy outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1)Couples that undergoing treatment whit own gametes
2)women under 40 ears old
3)Women whit at least 4 good quality embryo after thawing(grade A)
4)Women that did not have more than 1 previous embryo transfer
Exclusion criteria:
1)Cycles whit no PGD(Preimplantation genetic diagnosis)
2)Women whit no uterine anatomic disorder or hydrosalpinx
Age
To 42 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research center of Avicenna
Street address
97 no.Yakhchal street, Shariati Street.
City
Tehran
Postal code
19419113194
Approval date
2014-01-14, 1392/10/24
Ethics committee reference number
92-037
Health conditions studied
1
Description of health condition studied
In vitro fertilization
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Development of embryos to blastocysts
Timepoint
5 days after intervention
Method of measurement
Microscopic evaluation of embryos
2
Description
Implantation rate
Timepoint
5 weeks after intervention
Method of measurement
Vaginal ultrasonography
3
Description
Clinical pregnancy rate
Timepoint
6 weeks after intervention
Method of measurement
Vaginal ultrasonography
Secondary outcomes
1
Description
Quality of embryos
Timepoint
5 days after intervention
Method of measurement
Microscopic evaluation of embryos
2
Description
Beta HCG level
Timepoint
19 days after intervention
Method of measurement
Blood sample evaluation
3
Description
Evaluation of abortion under 12 weeks
Timepoint
12 weeks after intervention
Method of measurement
History of patient
4
Description
Multiple pregnancy
Timepoint
5 weeks after intervention
Method of measurement
Vaginal ultrasonography
Intervention groups
1
Description
In intervention group , embryos after thawing will cultured in medium with growth factor and in control group they will cultured in medium without growth factor. IN two groups will evaluate Blastocyst development and embryo quality.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and recurrent abortion treatment center of Avicenna
Full name of responsible person
Dr Sadeghi Mohammd Mehdi
Street address
97 no.Yakhchal street, Shariati Street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Infertility and recurrent abortion treatment center of Avicenna
Full name of responsible person
Mohammad Mehdi Akhondi
Street address
97 no.Yakhchal street, Shariati Street.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Infertility and recurrent abortion treatment center of Avicenna
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
Infertility and recurrent abortion of Avicenna
Full name of responsible person
Zafardoust Simin
Position
Obsteterics and Gynecologist- Fellowship of infertility