Evaluation of the effects of endometrial scratching on angiogenic growth factors expression in unexplained repeated implantation failure (RIF) patients
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Protocol summary
معیار ورود
بیماران با سن زیر 40 سال ،3 سیکل IVF ناموفق قبلی و پاسخ خوب به تحریک تخمک گذاری قبلی.
معیار عدم ورود
زنان مبتلا به میوم، هیدروسالپنکس، سل اندومتر، مصرف داروی خاص و داشتن بیماری هورمونی وارد مطالعه نمی شوند.
معیار ورود
بیماران با سن زیر 40 سال، 3 سیکل IVF ناموفق قبلی و پاسخ خوب به تحریک تخمک گذاری قبلی.
معیار عدم ورود
زنان مبتلا به میوم، هیدروسالپنکس، سل اندومتر، مصرف داروی خاص و داشتن بیماری هورمونی وارد مطالعه نمی شوند.
معیار ورود بیماران با سن زیر 40 سال،3 سیکل IVF ناموفق قبلی و پاسخ خوب به تحریک تخمک گذاری قبلی. معیار عدم ورود زنان مبتلا به میوم، هیدروسالپنکس، سل اندومتر، مصرف داروی خاص و داشتن بیماری هورمونی وارد مطالعه نمی شوند.
General information
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20
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2021-06-20, 1400/03/30
2021-06-20 00:00:00
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2022-04-15, 1401/01/26
2022-04-15 00:00:00
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2022-04-15, 1401/01/26
2022-04-15 00:00:00
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Sampling was completed in this design
Sampling was completed in this design
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نمونه گیری در این طرح تمام شد .
نمونه گیری در این طرح تمام شد .
Recruitment centers
#1
Name of recruitment center - English: Iran University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Mehrdad Bakhtiyari
Full name of responsible person - Persian: مهرداد بختیاری
Street address - English: Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 4567
Fax:
Email: mehr_bakhtiyari@yahoo.com
Web page address:
Name of recruitment center - English: Iran University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Mehrdad Bakhtiyari
Full name of responsible person - Persian: مهرداد بختیاری
Street address - English: Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 4567
Fax:
Email: Mehr_bakhtiyari@yahoo.com
Web page address:
Name of recruitment center - English: Iran University of Medical Sciences Name of recruitment center - Persian: دانشگاه علوم پزشکی ایران Full name of responsible person - English: Mehrdad Bakhtiyari Full name of responsible person - Persian: مهرداد بختیاری Street address - English: Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 8670 4567 Fax: Email: mehrMehr_bakhtiyari@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mehrdad Bakhtiyari
Full name of responsible person - Persian: مهرداد بختیاری
Street address - English: Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 4567
Fax:
Email: mehr_bakhtiyari@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mehrdad Bakhtiyari
Full name of responsible person - Persian: مهرداد بختیاری
Street address - English: Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 4567
Fax:
Email: Mehr_bakhtiyari@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mehrdad Bakhtiyari Full name of responsible person - Persian: مهرداد بختیاری Street address - English: Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 8670 4567 Fax: Email: mehrMehr_bakhtiyari@yahoo.com Web page address:
Protocol summary
Study aim
Determining the effect of endometrial scratching on the expression of angiogenic growth factors
Design
A randomized clinical trial with control group, double blind, and 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
Using a pipelle, endometrial scratching is performed by a gynecologist only in the intervention group in the clinic. In this study, the participating patients (creating the same conditions) and the researcher (through sample coding) will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients under 40 years of age, 3 previous unsuccessful IVF cycles and good response to previous ovulation stimulation.
Exclusion criteria:Women with myoma, hydrosalpinx, endometrial tuberculosis, taking certain medications and having hormonal diseases are not included in the study.
Intervention groups
Intervention: 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 iatrogenesis growth factor genes expression in endometrial specimens in the intervention group (with local endometrial scratching) compared with the control group (without local endometrial scratching)
General information
Reason for update
Sampling was completed in this design
Acronym
IRCT registration information
IRCT registration number:IRCT20210316050723N1
Registration date:2021-07-12, 1400/04/21
Registration timing:registered_while_recruiting
Last update:2022-06-12, 1401/03/22
Update count:4
Registration date
2021-07-12, 1400/04/21
Registrant information
Name
Samaneh Aghajanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2727
Email address
aghajanpour.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
2021-06-20, 1400/03/30
Actual recruitment end date
2022-04-15, 1401/01/26
Trial completion date
2022-04-15, 1401/01/26
Scientific title
Evaluation of the effects of endometrial scratching on angiogenic growth factors expression in unexplained repeated implantation failure (RIF) patients
Public title
Evaluation of the effects of endometrial scratching on angiogenic growth factors
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with repeated implantation failure refers to cases in which women have had three failed in vitro fertilization (IVF) attempts with good quality embryos.
Age range 20 to 40 years
Patients respond well to stimulation of previous ovulation.
Patients should have at least two embryos with good or excellent grade.
The uterus is normal on hysterosalpanagography examination or ultrasound or hysteroscopy.
Patient consent is required to participate in the study and to complete the consent form.
Exclusion criteria:
The thickness of the endometrium on the day of gonadotropin hormone injection is less than 7 mm.
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
Having more than 30% of DNA fragmentation index (DFI) in the examination of their spouses' sperm
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of school of medicine
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-06-12, 1400/03/22
Ethics committee reference number
IR.IUMS.FMD.REC.1400.147
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
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Bakhtiyari
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4567
Email
Mehr_bakhtiyari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Bakhtiyari
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4567
Email
Mehr_bakhtiyari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Bakhtiyari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4567
Email
mehr_bakhtiyari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Bakhtiyari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4567
Email
Mehr_bakhtiyari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Bakhtiyari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4567
Email
Mehr_bakhtiyari@yahoo.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. Mehrdad Bakhtiyari
What processes are involved for a request to access data/document