The aim of this prospective, randomized controlled study is Evaluation of effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer .
Inclusion criteria: Infertile patients candidate for frozen- thawed embryo transfer .
Exclusion criteria: women older than 40 years; women with history of endocrine disorders; intrauterine abnormality (uterine polyp, sub mucosal fibroma, intrauterine adhesion)and severe endometriosis . In intervention group (50 patients)in cycle 21-23 days (before embryo transfer cycle) ,the edometrium is scratched with piple .No intervention in control group is done.At the end, chemical and clinical pregnancy rates will be evaluated in intervention and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101324512N1
Registration date:2015-11-13, 1394/08/22
Registration timing:retrospective
Last update:
Update count:2
Registration date
2015-11-13, 1394/08/22
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd research and clinical center for infertility
Country
Iran (Islamic Republic of)
Phone
+98 358247085
Email address
abbas-aflatoonian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
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
The effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer
Public title
The effect of endometrial injury on pregnancy rate in frozen- thawed embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile patients candidate for frozen- thawed embryo transfer.
Exclusion criteria: women older than 40 years; women with history of endocrine disorders; intrauterine abnormality (uterine polyp, sub mucosal fibroma, intrauterine adhesion)and severe endometriosis .
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
yazd
Postal code
8916877391
Approval date
2015-02-10, 1393/11/21
Ethics committee reference number
445
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
Chemicall pregnancy
Timepoint
14 days after transfer
Method of measurement
B-HCG test
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
2 weeks after positive B-HCG
Method of measurement
vaginal ultrasonography
Intervention groups
1
Description
In intervention group (50 patients)in cycle 21-23 days (before embryo transfer cycle) ,the edometrium is scratched with piple .
Category
Treatment - Drugs
2
Description
No intervention in control group is done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Abass Aflatounian, Professor of Shahid Sadoughi University of medical sciences
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Abass Aflatounian
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Clinical Center for Infertility, 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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Abass Aflatounian
Position
Professor
Other areas of specialty/work
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr.Abass Aflatounian
Position
Professor
Other areas of specialty/work
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sadoughi University of Medical Sciences ,Yazd
Full name of responsible person
Dr.Abass Aflatounian
Position
Professor
Other areas of specialty/work
Street address
Bouali Ave, Safayeh , Research and Clinical Center for Infertility
City
yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)