Protocol summary

Summary
One of the strategies frequently failed IVF is embryo transfer in blastocyst stage and It is compared with embryo transfer in 2-3 days .Therefore, a study was conducted with this objective . . In this study, 100 women 20-40 years with more than 2 failed IVF embryo transfer randomly divided into two groups. 21 cycles of agonists, GnRH 500 mcg subcutaneously Will continue until the day of HCG injection. And the next cycle of 2-3 days Gonadotropin 150 IU is injected . Based on ovarian response, the drug dose is increased . And the size of the follicle reaches 18-20 mm, HCG injections are administered at a dose of 10,000 units. 36 hours after the eggs have been taken AND IVF with using sperm with eggs are fertilized . in the first group or the intervention early cleavage stage or 2-3 day old embryos are transferred and In the second or control group at the blastocyst stage (5 days) is passed. To all patients for luteal phase support suppositories Progesterone (Cyclojest t) 800 mg is administered . Success in reaching the stage of embryo transfer, Canceled cycles, pregnancy and abortion are the study outcomes .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201310025181N11
Registration date: 2013-10-15, 1392/07/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-15, 1392/07/23
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical Research Council ,Tehran University of Medical Sciences .
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy outcomes in two ways in the early stages of transition and transfer of Blastocyst in IVF in Asr Hospital.
Public title
Comparison of pregnancy outcomes in two embryo transfer in IVF
Purpose
Treatment
Inclusion/Exclusion criteria
I nclusion criteria :women with age 20-40 years؛ Embryo transfer with IVF failuremore than twice. Exclusion Criteria:Age more than 40 years ؛ Untreated women with uterine disorders؛ male infertility.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
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
School of Medicine, Tehran University of Medical Sciences
Street address
School ofMedicine,Ghods Street,Keshavarz BLVD
City
Tehran
Postal code
14194
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
21572

Health conditions studied

1

Description of health condition studied
Female infertility associated with anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
sonography

2

Description
Twin pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Sonography

3

Description
Abortion
Timepoint
after positive pregnancy test
Method of measurement
Sonography

4

Description
chemical pregnancy
Timepoint
two weeks after pregnancy
Method of measurement
blood test

Secondary outcomes

1

Description
NO of embryo transfered
Timepoint
in the transfering the embryo
Method of measurement
Embryolog specialist

2

Description
No of fertilized oocyte
Timepoint
Second day of fertilization Until the embryo transfer
Method of measurement
Embryologists recognized under microscope

Intervention groups

1

Description
21 cycles of agonists, GnRH 500 mcg subcutaneously Will continue until the day of HCG injection. And the next cycle of 2-3 days Gonadotropin 150 IU is injected . Based on ovarian response, the drug dose is increased . And the size of the follicle reaches 18-20 mm, HCG injections are administered at a dose of 10,000 units. 36 hours after the eggs have been taken AND IVF with using sperm with eggs are fertilized In the second or control group at the blastocyst stage (5 days) is passed.
Category
Treatment - Drugs

2

Description
21 cycles of agonists, GnRH 500 mcg subcutaneously Will continue until the day of HCG injection. And the next cycle of 2-3 days Gonadotropin 150 IU is injected . Based on ovarian response, the drug dose is increased . And the size of the follicle reaches 18-20 mm, HCG injections are administered at a dose of 10,000 units. 36 hours after the eggs have been taken AND IVF with using sperm with eggs are fertilized . in the first group or the intervention early cleavage stage or 2-3 day old embryos are transferred and
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-asr infertility Clinic
Full name of responsible person
Dr,Batool Hossein Rashidi
Street address
vali-Asr Reproductive Health Research Center,Tehran Medical University
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of School Medicine ,Tehran University of Medical Sciences
Full name of responsible person
Dr,Shahin Akhoondzadeh
Street address
Building Tehran University of Medical Sciences,Ghods Street,Keshavarz BLVD.
City
Tehran
Grant name
پایان نامه شماره 21522
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of School Medicine ,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
Vali-e-Asr reproductive HealthnResearch center
Full name of responsible person
Shahrokh Tehraninejad Ensieh
Position
Assistant professor
Other areas of specialty/work
Street address
Immam Khomeini Hospital , vali-Asr Hospital
City
Tehran
Postal code
Phone
+98 21 6693 9320
Fax
Email
tehraninejadensi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vali-asr Reoroductive Health Research Center
Full name of responsible person
Rashidi Batool
Position
Assistant Professor
Other areas of specialty/work
Street address
vali-Asr Reproductive Health Research Center, Vali-Asr Hospital.
City
Tehran
Postal code
14194
Phone
+98 21 6693 9320
Fax
Email
bhrashidi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Vali-E-Asr Reproductive Health Research Center
Full name of responsible person
Haghollahi Fedyeh
Position
Research expert
Other areas of specialty/work
Street address
Imam Khomeini hospital,Vali-e-asr hospital
City
Tehran
Postal code
14194
Phone
+98 21 6658 1616
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...