Protocol summary

Summary
This is a randomized clinical trial which has two groups: In control group there are 45 women. The control group will have blastocyst transfer at the 20th day of cycle. In the intervention group there are 45 women. This group will have 20µl of embryo culture medium (Blast Assist System2) injected into the uterine cavity at 17th day of cycle and then at the 20th day Blstocyct is transferred. This media is derived from media culture that the best embryos are cultured. At the 2nd day of culture the best embryos transferred to another media and are cultured till 5th day. The embryo culture medium injection is performed transcervically into the uterus using Cook IVF catheter. The catheter, loaded with 20 µl of embryo culture medium is inserted into uterine cavity and embryo is released. The tip of the catheter is about 1 cm from the fundus of the uterine cavity. Implantation rates and pregnancy rates will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902232576N2
Registration date: 2010-09-09, 1389/06/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-09, 1389/06/18
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university medical sciences,TEHRAN, IRAn
Expected recruitment start date
2009-09-01, 1388/06/10
Expected recruitment end date
2010-08-01, 1389/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of stimulation of endometrium before embryo transfer on pregnancy rates in patients undergoing assisted reproduction
Public title
Effects of stimulation of endometrium before embryo transfer on pregnancy rates in patients undergoing assisted reproduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All women with infertility who refer to infertility clinic of Valiasr reproductive health research center, age 20-38, infertility<10y Exclusion criteria: Age>38, Hydrosalpinx, FSH>10, History of IVF failure
Age
From 20 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran university of medical sciences
Street address
Tehran university medical sciences, 6th floor, Central Building of Tehran University of Medical Sciences, Keshavarz Boulevard, Ghods Avenue
City
TEHRAN
Postal code
Approval date
2009-11-12, 1388/08/21
Ethics committee reference number
9725

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Chemical pregnancy
Timepoint
After14 days of embryo transfer
Method of measurement
B-hcG

Secondary outcomes

1

Description
Clinical pregnancy
Timepoint
13 weeks
Method of measurement
Trans vaginal sonography

Intervention groups

1

Description
Intervention: Media that blastocyst has developed on it inserted via transcervical in 17th day and then blastocyst transfer is in 20th day
Category
Treatment - Other

2

Description
Control: blastocyst transfer is done at 20th day of cycle without media transfer on 17th day
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr reproductive health research center
Full name of responsible person
Fatemeh Davari Tanha
Street address
Women's hospital, Ostad Nejatollahi Shomally Avenue, Karim khan Zand bridge
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Pegahe Aslanpour
Street address
Tehran university of medical sciences - research adminstrator
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran university of medical sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Assistant professor
Other areas of specialty/work
Street address
Women's hospital, Ostad Nejatollahi Shomally Avenue, Karim khan Zand bridge
City
Tehran
Postal code
15978
Phone
+98 982188313955
Fax
Email
fdavaritanha@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Assistant professor
Other areas of specialty/work
Street address
Women's hospital, Ostad Nejatollahi Shomally Avenue, Karim khan Zand bridge
City
Tehran
Postal code
15978
Phone
+98 21 8831 3955
Fax
+98 21 8831 3955
Email
fdavaritanha@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact

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
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