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Evaluation of the effects of endometrial scratching on angiogenic and anti-angiogenic growth factors expression in unexplained repeated implantation failure (uRIF) patients

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History
# Registration date Revision Id
5 2024-01-22, 1402/11/02 292763
4 2023-11-08, 1402/08/17 287340
3 2023-09-27, 1402/07/05 281898
2 2022-06-11, 1401/03/21 229581
1 2021-07-12, 1400/04/21 189969
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  • Secondary outcomes

    #1
    Age
    Total dose of gonadotropin (IU)
    سن
    دوز کلی گنادوتروپین (واحد بین الملل)
    At the time of entering the study
    From ovarian stimulation to human chorionic gonadotropin (hCG) injection
    در زمان ورود به مطالعه
    از شروع تحریک تخمدان تا تزریق هورمون گنادوتروپین جفتی انسان (hCG)
    Based on the person's birth certificate and the information contained in the file
    The number of international units (IU) received during the ovarian stimulation cycle
    بر اساس شناسنامه فرد و اطلاعات مندرج در پرونده
    تعداد واحد بین الملل (IU) دریافت شده در طول سیکل تحریک تخمدان
    #2
    Duration of infertility (years)
    Duration of ovarian stimulation (day)
    مدت زمان ناباروری (سال)
    مدت زمان تحریک تخمدان (روز)
    At the time of entering the study
    From the start of gonadotropin administration to human chorionic gonadotropin (hCG) injection
    در زمان ورود به مطالعه
    از شروع تجویز گنادوتروپین تا تزریق گنادوتروپین جفتی انسان(hCG)
    According to the history taken by the infertility specialist at the time of filing the case (trying to get pregnant despite regular intercourse)
    According to the patient's monitoring ultrasound chart (number of days receiving the medicine)
    طبق شرح حال اخذ شده توسط متخصص ناباروری در زمان تشکیل پرونده (تلاش جهت بارداری با وجود نزدیکی منظم)
    طبق چارت سونوگرافی مانیتورینگ بیمار (تعداد روز دریافت دارو)
    #3
    Body mass index
    Number of retrieved oocytes
    شاخص توده بدنی
    تعداد تخمک‌های به‌دست آمده
    At the time of entering the study
    On the day of oocyte pick-up
    در زمان ورود به مطالعه
    در روز تخمک‌کشی
    Weight divided by the square of height in meters
    The number of retrieved oocytes reported in the embryology chart
    وزن تقسیم بر مجذور قد به متر
    تعداد تخمک های به دست آمده گزارش شده در چارت جنین شناسی
    #4
    Luteinizing hormone (LH )
    Metaphase II oocytes
    هورمون لوتئینه کننده (LH)
    تخمک‌های متافاز II
    On the third day of menstruation
    On the day of oocyte pick-up
    در روز سوم قاعدگی
    در روز تخمک‌کشی
    LH titer in blood serum using ELISA method (IU/L)
    Based on the presence of the polar body reported by the embryologist
    تیتر LH در سرم خون با استفاده از روش الایزا (واحد بین المللی بر لیتر)
    براساس وجود گویچه قطبی گزارش شده توسط جنین شناس
    #5
    Follicle-Stimulating Hormone (FSH)
    Number of embryos
    هورمون تحریک کننده فولیکول (FSH)
    تعداد جنین
    On the third day of menstruation
    Three or five days after oocyte pick-up
    در روز سوم قاعدگی
    سه یا پنج روز پس از تخمک‌کشی
    FSH titer in blood serum using ELISA method (IU/L)
    The number of cleavage embryos reported by the embryologist
    تیتر FSH در سرم خون با استفاده از روش الایزا (واحد بین المللی بر لیتر)
    تعداد جنین‌های تسهیم شده گزارش شده توسط جنین شناس
    #6
    Anti Mullerian Hormone (AMH)
    Embryo transfer cancelation
    هورمون آنتی مولرین (AMH)
    انتقال جنین کنسل شده
    On the third day of menstruation
    Three or five days after oocyte pick-up
    در روز سوم قاعدگی
    سه یا پنج روز پس از تخمک‌کشی
    AMH titer in blood serum using ELISA method (ng/ml)
    Participants with no embryo transfer
    تیتر AMH در سرم خون با استفاده از روش الایزا (واحد نانوگرم بر میلی لیتر)
    شرکت کنندگان با عدم انتقال جنین
    #7
    Total dose of gonadotropin (IU)
    Chemical pregnancy rate/Embryo transfer
    دوز کلی گنادوتروپین (واحد بین الملل)
    حاملگی شیمیایی به ازای انتقال جنین
    From ovarian stimulation to human chorionic gonadotropin (hCG) injection
    2 weeks after embryo transfer
    از شروع تحریک تخمدان تا تزریق هورمون گنادوتروپین جفتی انسان (hCG)
    2هفته بعد از انتقال جنین
    The number of international units (IU) received during the ovarian stimulation cycle
    Beta human chorionic gonadotropin (beta hCG) titer in blood serum by ELISA method
    تعداد واحد بین الملل (IU) دریافت شده در طول سیکل تحریک تخمدان
    تیتر هورمون بتا گنادوتروپین انسانی در سرم خون با روش الایزا
    #8
    Duration of ovarian stimulation (day)
    Blighted ovum/Embryo transfer
    مدت زمان تحریک تخمدان (روز)
    حاملگی پوچ به ازای انتقال جنین
    From the start of gonadotropin administration to human chorionic gonadotropin (hCG) injection
    5 weeks after embryo transfer
    از شروع تجویز گنادوتروپین تا تزریق گنادوتروپین جفتی انسان(hCG)
    5 هفته بعد از انتقال جنین
    According to the patient's monitoring ultrasound chart (number of days receiving the medicine)
    Absence of fetus in gestational sac according to ultrasound report
    طبق چارت سونوگرافی مانیتورینگ بیمار (تعداد روز دریافت دارو)
    عدم وجود جنین در ساک حاملگی طبق گزارش سونوگرافی
    #9
    Number of retrieved oocytes
    Ectopic pregnancy/Embryo transfer
    تعداد تخمک‌های به‌دست آمده
    حاملگی خارج از رحم به ازای انتقال جنین
    On the day of oocyte pick-up
    5 weeks after embryo transfer
    در روز تخمک‌کشی
    5 هفته بعد از انتقال جنین
    The number of retrieved oocytes reported in the embryology chart
    According to the ultrasound report, there is a gestational sac outside the uterus with a positive Beta hCG titer
    تعداد تخمک های به دست آمده گزارش شده در چارت جنین شناسی
    طبق گزارش سونوگرافی مبنی بر وجود ساک حاملگی در خارج از رحم با وجود تیتر Beta hCG مثبت
    #10
    Metaphase II oocytes
    Miscarriage rate/Embryo transfer
    تخمک‌های متافاز II
    نرخ سقط به ازای سیکل انتقال جنین
    On the day of oocyte pick-up
    Pregnancy loss before 20 weeks
    در روز تخمک‌کشی
    از دست دادن حاملگی قبل از هفته 20
    Based on the presence of the polar body reported by the embryologist
    Excretion of pregnancy remnants with vaginal bleeding (absence of heartbeat according to ultrasound report)
    براساس وجود گویچه قطبی گزارش شده توسط جنین شناس
    دفع بقایای حاملگی همراه با خونریزی واژینال (عدم ضربان قلب طبق گزارش سونوگرافی)
    #11
    Number of embryos
    Multiple Pregnancy (Twin)
    تعداد جنین
    حاملگی چند قلویی (دو قلویی)
    Three or five days after oocyte pick-up
    5 weeks after embryo transfer
    سه یا پنج روز پس از تخمک‌کشی
    5 هفته بعد از انتقال جنین
    The number of cleavage embryos reported by the embryologist
    Ultrasound report based on the number of gestational sacs with embryo
    تعداد جنین‌های تسهیم شده گزارش شده توسط جنین شناس
    گزارش سونوگرافی مبنی بر تعداد ساک حاملگی با جنین
    #12
    Embryo transfer cancelation
    Live birth rate/Embryo transfer
    انتقال جنین کنسل شده
    تولد زنده به ازای انتقال جنین
    Three or five days after oocyte pick-up
    Time of delivery
    سه یا پنج روز پس از تخمک‌کشی
    زمان زایمان
    Participants with no embryo transfer
    Birth of a live baby
    شرکت کنندگان با عدم انتقال جنین
    تولد نوزاد زنده
    #13
    Chemical pregnancy rate/Embryo transfer
    Fertilization rate
    حاملگی شیمیایی به ازای انتقال جنین
    نرخ لقاح
    2 weeks after embryo transfer
    The day after the sperm injection
    2هفته بعد از انتقال جنین
    روز بعد از تزریق اسپرم
    Beta human chorionic gonadotropin (beta hCG) titer in blood serum by ELISA method
    number of oocytes with two pronuclei (2PN) divided by the number of injected oocytes
    تیتر هورمون بتا گنادوتروپین انسانی در سرم خون با روش الایزا
    تعداد تخمک های با دو پیش هسته (2PN) تقسیم بر تعداد تخمک های تزریق شده
    #14
    Blighted ovum/Embryo transfer
    empty
    حاملگی پوچ به ازای انتقال جنین
    empty
    5 weeks after embryo transfer
    empty
    5 هفته بعد از انتقال جنین
    empty
    Absence of fetus in gestational sac according to ultrasound report
    empty
    عدم وجود جنین در ساک حاملگی طبق گزارش سونوگرافی
    empty
    #15
    Ectopic pregnancy/Embryo transfer
    empty
    حاملگی خارج از رحم به ازای انتقال جنین
    empty
    5 weeks after embryo transfer
    empty
    5 هفته بعد از انتقال جنین
    empty
    According to the ultrasound report, there is a gestational sac outside the uterus with a positive Beta hCG titer
    empty
    طبق گزارش سونوگرافی مبنی بر وجود ساک حاملگی در خارج از رحم با وجود تیتر Beta hCG مثبت
    empty
    #16
    Miscarriage rate/Embryo transfer
    empty
    نرخ سقط به ازای سیکل انتقال جنین
    empty
    Pregnancy loss before 20 weeks
    empty
    از دست دادن حاملگی قبل از هفته 20
    empty
    Excretion of pregnancy remnants with vaginal bleeding (absence of heartbeat according to ultrasound report)
    empty
    دفع بقایای حاملگی همراه با خونریزی واژینال (عدم ضربان قلب طبق گزارش سونوگرافی)
    empty
    #17
    Multiple Pregnancy (Twin)
    empty
    حاملگی چند قلویی (دو قلویی)
    empty
    5 weeks after embryo transfer
    empty
    5 هفته بعد از انتقال جنین
    empty
    Ultrasound report based on the number of gestational sacs with embryo
    empty
    گزارش سونوگرافی مبنی بر تعداد ساک حاملگی با جنین
    empty
    #18
    Live birth rate/Embryo transfer
    empty
    تولد زنده به ازای انتقال جنین
    empty
    Time of delivery
    empty
    زمان زایمان
    empty
    Birth of a live baby
    empty
    تولد نوزاد زنده
    empty
    #19
    Fertilization rate
    empty
    نرخ لقاح
    empty
    The day after the sperm injection
    empty
    روز بعد از تزریق اسپرم
    empty
    number of oocytes with two pronuclei (2PN) divided by the number of injected oocytes
    empty
    تعداد تخمک های با دو پیش هسته (2PN) تقسیم بر تعداد تخمک های تزریق شده
    empty

Protocol summary

Study aim
Determining the effect of endometrial scratching on the expression of angiogenic and anti-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: Women with Unexplained repeated implantation failure(uRIF), 20 to 40 years, Body max index less (BMI) than 25, good response to previous ovulation stimulation, at least two embryos with good grade in the current cycle, normal uterus. Exclusion criteria: Endometrial thickness is less than 7 mm, congenital anomalies,myoma,endometrioma, adhesions, hydrosalpinx, previous uterine or ovarian surgery, severe male factor infertility, number of embryos less than 2 in the current cycle, diabetes, thyroid disease, any endocrine, genetic, infection or autoimmune disorder
Intervention groups
Intervention: In the intervention group, endometrial sampling is obtained twice by Pipelle [one in the follicular phase and the last in the luteal phase of the same cycle preceding the embryo transfer cycle. Control group: In the control group endometrial sampling will be done only in the luteal phase of the cycle preceding the embryo transfer cycle.
Main outcome variables
Determination of angiogenic and anti-angiogenic growth factor gene expression in endometrial specimens in the intervention group compared with the control group

General information

Reason for update
According to the previous report, the actual recruitment end date of hospitalization is the same as 01/26/1401, and the only date of trial completion date is according to the examination of clinical pregnancy (5 weeks after embryo transfer) and live birth (9 months of pregnancy)in the participant's plan has increased. In addition, according to the evaluation of the secondary variables of implantation rate and clinical pregnancy, the variables related to them that are evaluated are added. A little rewriting has been done in the way the inclusion and exclusion criteria are expressed.
Acronym
IRCT registration information
IRCT registration number: IRCT20210316050723N1
Registration date: 2021-07-12, 1400/04/21
Registration timing: registered_while_recruiting

Last update: 2024-01-27, 1402/11/07
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
2023-01-21, 1401/11/01
Scientific title
Evaluation of the effects of endometrial scratching on angiogenic and anti-angiogenic growth factors expression in unexplained repeated implantation failure (uRIF) patients
Public title
Evaluation of the effects of endometrial scratching on angiogenic and anti-angiogenic growth factors
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with unexplained repeated implantation failure (unknown definite causes of RIF) failed to conceive after three or more embryo transfer cycles using high-quality transferred embryos (at least one blastocyst ET cycle) Age of 20 to 40 years Body mass index (BMI) less than 25 kg/m2 Good response to stimulation of previous ovulation Having at least two embryos with good grade normal uterus results of hysterosalpingography (HSG) or hysteroscopy Participant consent was required to join in the study and to complete the consent form
Exclusion criteria:
The thickness of the endometrium on the day of Human chorionic gonadotropin hormone injection is less than 7 mm Women with congenital anomalies, intramural and subserosal myomas( larger than 5 cm) Submucosal myoma Women with endometrioma larger than or equal to 3 cm With adhesions With hydrosalpinx Have previous uterine or ovarian surgery Severe male factor infertility (sperm extraction from the testis, sperm freezing, sperm DNA fragmentation index equal to or above 16%) Patients with any specific medication If the number of available embryos is less than 2 in the current cycle Women with endometrial tuberculosis and those undergoing tuberculosis treatment Have a history of diabetes, thyroid disease, any endocrine, genetic, infection or autoimmune disorder Abnormal Pre-implantation Genetic Test (PGT) Results Any specific medication Failure to return the patient to prepare an endometrial sample Women with severe pain during obtaining of tissue samples or the possibility of infection
Age
From 20 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 8-11. The biopsy specimen is prepared in the luteal phase of the same cycle during days 19-23 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 the conditions will be the same between the two groups, so the patients of the control group also referred to the center on the day of the scratching (8-11) and due to the blinding of the study, all the sampling steps were done except endometrial scratching will be done for the control group as well as the intervention group. Then, biopsy samples are prepared from both groups in the luteal phase on days 19-23. The endometrial biopsy sample of both groups is sent to the laboratory, which does not know whether the tissue sample received is for the intervention group or the control group, and only checks it based on the received code (blinding of the researcher).
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
Unexplained repeated implantation failure (uRIF)
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 19-23
Method of measurement
Using PCR Array method and based on the copy number

Secondary outcomes

1

Description
Clinical pregnancy
Timepoint
5 weeks after embryo transfer
Method of measurement
Vaginal ultrasonography (observing the gestational sac and fetal heart rate)

2

Description
Implantation
Timepoint
5 weeks after embryo transfer
Method of measurement
The number of observed sacs divided by the number of transferred embryos

3

Description
Total dose of gonadotropin (IU)
Timepoint
From ovarian stimulation to human chorionic gonadotropin (hCG) injection
Method of measurement
The number of international units (IU) received during the ovarian stimulation cycle

4

Description
Duration of ovarian stimulation (day)
Timepoint
From the start of gonadotropin administration to human chorionic gonadotropin (hCG) injection
Method of measurement
According to the patient's monitoring ultrasound chart (number of days receiving the medicine)

5

Description
Number of retrieved oocytes
Timepoint
On the day of oocyte pick-up
Method of measurement
The number of retrieved oocytes reported in the embryology chart

6

Description
Metaphase II oocytes
Timepoint
On the day of oocyte pick-up
Method of measurement
Based on the presence of the polar body reported by the embryologist

7

Description
Number of embryos
Timepoint
Three or five days after oocyte pick-up
Method of measurement
The number of cleavage embryos reported by the embryologist

8

Description
Embryo transfer cancelation
Timepoint
Three or five days after oocyte pick-up
Method of measurement
Participants with no embryo transfer

9

Description
Chemical pregnancy rate/Embryo transfer
Timepoint
2 weeks after embryo transfer
Method of measurement
Beta human chorionic gonadotropin (beta hCG) titer in blood serum by ELISA method

10

Description
Blighted ovum/Embryo transfer
Timepoint
5 weeks after embryo transfer
Method of measurement
Absence of fetus in gestational sac according to ultrasound report

11

Description
Ectopic pregnancy/Embryo transfer
Timepoint
5 weeks after embryo transfer
Method of measurement
According to the ultrasound report, there is a gestational sac outside the uterus with a positive Beta hCG titer

12

Description
Miscarriage rate/Embryo transfer
Timepoint
Pregnancy loss before 20 weeks
Method of measurement
Excretion of pregnancy remnants with vaginal bleeding (absence of heartbeat according to ultrasound report)

13

Description
Multiple Pregnancy (Twin)
Timepoint
5 weeks after embryo transfer
Method of measurement
Ultrasound report based on the number of gestational sacs with embryo

14

Description
Live birth rate/Embryo transfer
Timepoint
Time of delivery
Method of measurement
Birth of a live baby

15

Description
Fertilization rate
Timepoint
The day after the sperm injection
Method of measurement
number of oocytes with two pronuclei (2PN) divided by the number of injected oocytes

Intervention groups

1

Description
Intervention group: In the intervention group, endometrial sampling is obtained twice by Pipelle [one in the follicular phase (during 8-11 days and the last in the luteal phase (during 19-23 days) preceding the embryo transfer cycle. The endometrial scratching 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
Laleh Hospital
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
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
Request via e-mail
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