Molecular evaluation of endometrium obtained from women with repeated implantation failure (RIF) after endometrial injury in compare to women without endometrial injury
Molecular evaluation of endometrium obtained from women with repeated implantation failure (RIF) after endometrial injury in compare to women without endometrial injury
Design
A randomized clinical trial with control group, double blind, two arm parallel group design of 20 patients. Randomization is performed using a computer-generated random assignment schedule for each patient. Sealed and numbered envelopes are used to conceal the treatment allocation until randomization.
Settings and conduct
Female infertility Clinic of ROYAN institute.
Participants/Inclusion and exclusion criteria
- less thsn 40 years old
- Patients had history of 3 failed consecutive cycles of IVF / ICSI.
- Patients were good responders in prior ovulation induction cycle.
- There were at least two embryos with grade A in each embryo transfer cycle.
- Normal uterus in Hysterosalpingography (HSG) or ultrasound or hysteroscopy scans.
- The minimum thickness of the endometrium is 7 mm in injection day.
Intervention groups
ntervention: Endometrial injury
In the intervention group, endometrial sampling is obtained twice by Pipelle [one in the follicular phase (during 8-9 or 11- 13 day in the beginning of buserelin cycle) and the last in the luteal phase (during 19-21 or 20-23 day) of the same cycle preceding the embryo transfer cycle.
No Intervention: Control
In the control group endometrial sampling will be done only in the luteal phase (during 19-21 or 20-23 day) of the cycle preceding the embryo transfer cycle.
Main outcome variables
Determination of cytokine and chemokine genes expression in endometrial specimens in the intervention group (with local endometrial abrasion) compared with the control group (without local endometrial abrasion)
General information
Reason for update
Acronym
RIF-Injury
IRCT registration information
IRCT registration number:IRCT20080831001141N28
Registration date:2020-11-25, 1399/09/05
Registration timing:retrospective
Last update:2020-11-25, 1399/09/05
Update count:0
Registration date
2020-11-25, 1399/09/05
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
Expected recruitment start date
2014-06-30, 1393/04/09
Expected recruitment end date
2016-06-29, 1395/04/09
Actual recruitment start date
2014-06-30, 1393/04/09
Actual recruitment end date
2020-09-09, 1399/06/19
Trial completion date
2020-09-09, 1399/06/19
Scientific title
Molecular evaluation of endometrium obtained from women with repeated implantation failure (RIF) after endometrial injury in compare to women without endometrial injury
Public title
Molecular evaluation of endometrium after endometrial injury
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with repeated implantation failure (RIF) refers to cases in which women have had three failed in vitro fertilization (IVF) attempts with good quality embryos.
Exclusion criteria:
Women with Sub mucosal myoma
Women with Intramural and subserosal myomas larger than 5 cm
Women with Endometrioma larger than or equal to 3 cm
Women with Hydrosalpinx
If the number of available embryos is less than 2 in the current cycle
Women with endometrial tuberculosis and those undergoing tuberculosis treatment.
Patients with any specific medication
Patients with a history of thyroid disease, diabetes and other hormonal disorders and diseases
Failure to return the patient to prepare an endometrial sample
Inability to obtain tissue samples from patients due to severe pain or the possibility of infection
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Consecutive sampling until the required sample size is reached.
Women by Balanced Block Randomization method are randomly divided into 2 equal groups of 10 people (intervention group and control group). Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 4.
Envelopes are prepared for 20 people and inside each envelope is written the group in which the patient should be placed. The envelopes are prepared in a way that the writing inside is not clear. A nurse before the patient enters the operating room, removes the envelope and sends the patients in one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, a doctor scratches the endometrium in the intervention group on days 8-9 or 11-13. The biopsy specimen is prepared in the luteal phase of the same cycle during days 19-21 or 20-23 by the same doctor or other. Therefore, in this study, it is not possible to blind the doctor. In order to blind the patients participating in this study, all conditions will be the same between the two groups, so patients in the control group also referred to the center on the day of scratching (on days 8-9 or 11-13) and due to the blindness of the study, all sampling steps except scratching The endometrium will be performed for the control group as well as the intervention group. The endometrial biopsy specimen of both groups is transferred to the Laboratory, which also does not know information about whether the tissue sample received is for the intervention or control group and examines it only based on the received code (researcher blindness).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا (www.clinicaltrial.gov)
Secondary trial Id
NCT02480127
Registration date
2015-06-24, 1394/04/03
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Royan Institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2014-08-12, 1393/05/21
Ethics committee reference number
EC/93/1070
Health conditions studied
1
Description of health condition studied
repeated implantation failure (RIF)
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Evaluation of gene expression
Timepoint
In the endometrial sample obtained in the luteal phase during days 19-21 or 20-23
Method of measurement
Using PCR Array method and based on the copy number
Secondary outcomes
1
Description
clinical pregnancy rate
Timepoint
Only once; 6 weeks after embryo transfer.
Method of measurement
Vaginal ultrasound
Intervention groups
1
Description
Intervention group: In the intervention group, endometrial sampling is obtained twice by Pipelle [one in the follicular phase (during 8-9 or 11- 13 day in the beginning of buserelin cycle) and the last in the luteal phase (during 19-21 or 20-23 day) preceding the embryo transfer cycle.The endometrial injury which is induced with pipelle.
Category
Treatment - Other
2
Description
Control group: In the control group endometrial sampling will be done only in the luteal phase of the cycle preceding the embryo transfer cycle.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of ROYAN
Full name of responsible person
Mahnaz Ashrafi
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2727
Email
dr.mahnaz.ashrafi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ROYAN Institute
Full name of responsible person
Parvaneh Afsharian
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2727
Email
pafshar@royaninstitute.org
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
ROYAN Institute
Full name of responsible person
مهناز اشرفی
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2727
Email
dr.mahnaz.ashrafi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Mahnaz Ashrafi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2727
Email
dr.mahnaz.ashrafi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Mahnaz Ashrafi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway
City
Tehran
Province
Tehran
Postal code
148- 16635
Phone
+98 21 2356 2727
Email
dr.mahnaz.ashrafi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Clinical study report (published article)
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Available to the public
Under which criteria data/document could be used
Scientific use by citing the source
From where data/document is obtainable
Dr. Mahnaz Ashrafi
What processes are involved for a request to access data/document