Implantation of the human embryo is the limiting factor in the success of invitro-fertilization and embryo transfer (IVF-ET).We wanted to find out whether creating a local injury to the endometrium in the non-transfer cycle would improve the IVF-ET outcome in the subsequent cycle. We believe that the injury created causes release of substances which help in implantation.
Study Design and Subjects: This is a randomized control study designed to evaluate the effect of local injury to the endometrium in non-transfer cycle in patients with previous failed IVF (at least ≥1 cycles have failed).
Patients will be randomly allotted to control and intervention group. The patients in the intervention group Pipelle endometrial sampling 19-21th day (biopsy in luteal) in the cycle prior to IVF transfer cycle.
Outcome Measures: Clinical pregnancy rate, implantation rate and ongoing pregnancy rate
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302091141N13
Registration date:2013-03-07, 1391/12/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-07, 1391/12/17
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2013-04-03, 1392/01/14
Expected recruitment end date
2014-02-04, 1392/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of endometrial local injury in increasing pregnancy rate in patients undergoing ART (IVF/ICSI)
Public title
The effect of endometrial local injury in increasing pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Previous failed In-vitro fertilization embryo transfer cycle (at least ≥1 cycles have failed); Patients who are good responders and have good quality embryos in the previous attempts; Age of patients up to 40 years. Exclusion Criteria: Those with intramural fibroid distorting the endometrial cavity/sub-mucous myoma; Those with sonographically detected hydrosalpinx; age over than 40 years old; poor responders to ovarian stimulation.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
220
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
Royan Institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-02-04, 1391/11/16
Ethics committee reference number
EC/91/1132
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4-6 weeks after embryo transfer
Method of measurement
Ultrasound visualization of a gestational sac
Secondary outcomes
1
Description
Biochemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
BhCG test
2
Description
Implantation
Timepoint
4-6 weeks after embryo transfer
Method of measurement
Number of sacs by Sonography
3
Description
Endometrial thickness
Timepoint
Third day
Method of measurement
Sonography
4
Description
Early abortion
Timepoint
Week 12
Method of measurement
Sonography
5
Description
Late abortion
Timepoint
Week 20
Method of measurement
Sonography
Intervention groups
1
Description
Pipelle endometrial sampling 19-21th day in the cycle prior to IVF transfer cycle.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Dr Mahnaz Ashrafi
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Mahnaz Ashrafi
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
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
Royan Institute
Full name of responsible person
Dr Mahnaz Ashrafi
Position
Gynecologist/Head of Endocrinology and Female Infertility Department of Royan Institute
Other areas of specialty/work
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2644
Fax
+98 21 2230 6481
Email
Ashrafim@royaninstitute.org
Web page address
www.royaninstitute.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Mahnaz Ashrafi
Position
Gynecologist
Other areas of specialty/work
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2644
Fax
+98 21 2230 6481
Email
Ashrafim@royaninstitute.org
Web page address
www.royaninstitute.org
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Mahnaz Ashrafi
Position
Gynecologist
Other areas of specialty/work
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2644
Fax
+98 21 2230 6481
Email
Ashrafim@royaninstitute.org
Web page address
www.royaninstitute.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)