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Effect of local scratch of endometrium on the outcome of pregnancy in women with the previous failure of intrauterine insemination

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History
# Registration date Revision Id
3 2021-03-04, 1399/12/14 174051
2 2021-02-27, 1399/12/09 173506
1 2018-09-03, 1397/06/12 58242
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  • Protocol summary

    interventional study that was conducted on a randomized clinical trials in infertility center during 6 months.336patients 173 case,163control
    interventional study that was conducted on a non_randomized clinical trials in infertility center during 6 months.336patients 173 case,163control
    روش نمونه گیری تصادفی سیستماتیک میباشد با توجه به تعداد بیماران مراجعه کننده به مرکز نازایی سعی میشود در طی مدت 6 ماه336 نمونه جمع اوری شود
    کارازمایی بالینی باروش نمونه گیری غیر تصادفی سازی شده میباشد با توجه به تعداد بیماران مراجعه کننده به مرکز نازایی سعی میشود در طی مدت 6 ماه336 نمونه جمع اوری شود
    Infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI.Inclusion criteria:Patients are candidates for induction ovulation and intrauterine insemination.Normalized thyroid and prolactin function tests.Age range18 to 40 years. Having at least one healthy fallopian tube and normal uterine cavity. Normalized semen fluid or mild disorders.At least one year of infertility due to regular sexual intercourse 2-3 per week, despite using of preventive methods.Exclusion criteria:No consent to participate in the study.Poor Response patients. Disturbance thyroid function and high prolactin.Tubal abnormalities leading to infertility amoderate to severe in terms number and morphology sperm.People with polycybnormalities leading to infertility.Semen analysis disorder. polystic ovary syndrome
    Infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI.Inclusion criteria:Patients are candidates for induction ovulation and intrauterine insemination.Normalized thyroid and prolactin function tests.Age range18 to 40 years.BMI<30kg/m2,and1
    زنان بامشکل نازایی که بدنبال یک یا دوبار شکست در روش تلقیح داخل رحمی قصد بارداری دارند.و کاندید مجدد روش تلقیح داخل رحمی میباشند. معیار های ورود: بیماران کاندید اینداکشن اوولیشن و تلقیح داخل رحمی .نرمال بودن تست های عملکرد تیرویید و پرولاکتین .محدوده سنی 18 تا40 سال .دارای حداقل یک لوله فالوپ سالم و حفره رحمی نرمال .انالیز مایع سمن همسر نرمال ویا اختلالات خفیف داشته باشد 6.سابقه حداقل یکسال نازایی با توجه به مقاربت های منظم(2-3)بار در هفته و عدم استفاده از روش های پیشگیری.افراد مبتلا به سندرم تخمدان پلی کیستیک.معیارهای خروج از : عدم رضایت به شرکت در مطالعه.افراد پور رسپانس.اختلال عملکرد تیرویید و پرولاکتین بالا .اختلالات لوله ای رحمی که منجر به نازایی شده باشد.اختلال مایع سمن در حد متوسط تا شدید از نظر تعداد حرکت و شکل اسپرم.افراد مبتلا به سندرم تخمدان های پلی کیستیک
    زنان بامشکل نازایی که بدنبال یک یا دوبار شکست در روش تلقیح داخل رحمی قصد بارداری دارند.و کاندید مجدد روش تلقیح داخل رحمی میباشند. معیار های ورود: بیماران کاندید اینداکشن اوولیشن و تلقیح داخل رحمی .نرمال بودن تست های عملکرد تیرویید و پرولاکتین .محدوده سنی 18 تا40 سال,توده بدنی کمتر از ۳۰،انتی مولرین هورمون بین ۱تا۳/۵، .دارای حداقل یک لوله فالوپ سالم و حفره رحمی نرمال .انالیز مایع سمن همسر نرمال ویا اختلالات خفیف داشته باشد ،معیارهای خروج از : عدم رضایت به شرکت در مطالعه.افراد پور رسپانس(انتی مولرین هورمون کمتر از۱نانگرم در دسی لیتر).اختلال عملکرد تیرویید و پرولاکتین بالا .اختلالات لوله ای رحمی دوطرفه یا هیدروسالپنکس ،.افراد مبتلا به بیماری تخمدان های پلی کیستیک

  • General information

    Change in the number of sample and change in the time of writing manuscript due to the large number of samples and prolonged duration of sampling
    Change in the inclusion and exclusion criteria to increase accuracy in selected sample cases of study and change in the number of sample and change in the time of study due to the large number of samples and prolonged duration of sampling
    تغییر در تعداد حجم نمونه وتغییر درتاریخ انجام مقاله به دلیل به تعداد زیاد نمونه و طولانی شدن مدت زمان نمونه گیری
    تغییر در معیارهای ورود وخروج از مطالعه برای افزایش دقت مطالعه وتغییردر تعداد حجم نمونه وتغییر درتاریخ انجام مقاله به دلیل تعداد زیاد نمونه و طولانی شدن مدت زمان نمونه گیری
    Infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI
    Inclusion criteria of the study were:infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI despite proper ovolation and primary and secondary infirtility with having at least one patent fallopian tube,women eged18_40years BMI<30kg/m2and1
    زنان بامشکل نازایی که بدنبال یک یا دوبار شکست در روش تلقیح داخل رحمی قصد بارداری دارند.و کاندید مجدد روش تلقیح داخل رحمی میباشند.
    معیار ورود به مطالعه :زنان بامشکل نازایی که بدنبال یک یا دوبار شکست در روش تلقیح داخل رحمی قصد بارداری دارند.و کاندید مجدد روش تلقیح داخل رحمی میباشند.علی رغم تخمک گذاری مناسب ونازایی اولیه وثانویه،حداقل یک لوله فالوپ سالم دارند،
    سن ۱۸تا۴۰سال،شاخص توده بدنی کمتراز ۳۰و انتی مولرین هورمون بین ۱تا۳/۵،وعملکرد تیرویید وپرولاکتین نرمال
    انالیز مایع منی نرمال و اولیگواسپرمی خفیف
    1. No consent to participate in the study2. Poor Response patients3. Disturbance of thyroid function and high prolactin4. Tubal abnormalities leading to infertility5. Semen analysis disorder (moderate to severe in terms of number and morphology of sperm) 6. People with polycystic ovary syndrome
    Exclusion criteria,. No consent to participate in the study, Poor Response patients(AMH<1ng/dl) Disturbance of thyroid function and high prolactin, double blocked fallopian tubes or hydrosalpinx), People with polycystic ovary disease(PCOD)
    1.عدم رضایت به شرکت در مطالعه2.افراد پور رسپانس3.اختلال عملکرد تیرویید و پرولاکتین بالا 4.اختلالات لوله ای رحمی که منجر به نازایی شده باشد5.اختلال مایع سمن در حد متوسط تا شدید از نظر تعداد حرکت و شکل اسپرم6.افراد مبتلا به سندرم تخمدان های پلی کیستیک
    .عدم رضایت به شرکت در مطالعه.افراد پور رسپانس(انتی مولرین هورمون کمتر ازیک نانوگرم دردسی لیتر).اختلال عملکرد تیرویید و پرولاکتین بالا ,انسداد دوطرفه لوله یا هیدروسالپنکس.افراد مبتلا به بیماری تخمدان های پلی کیستیک

Protocol summary

Study aim
Effect local scratch endometrium on outcome pregnancy in women with previous failure intrauterine insemination
Design
interventional study that was conducted on a non_randomized clinical trials in infertility center during 6 months.336patients 173 case,163control
Settings and conduct
336women with infertile women in are divided into two groups of173and163 patients.the group referring to infertility clinic on odd days,is consulted to participate in design and intervention,and after receiving informed consenton 8-9 days of menstrual cycle,endometrial scratch using Pipelle catheter is performed,but patients referring in even days, will be without any intervention and are divided into control group.On the 14th day after IUI,the biochemical pregnancy rate is measured with positive beta-test.
Participants/Inclusion and exclusion criteria
Infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI.Inclusion criteria:Patients are candidates for induction ovulation and intrauterine insemination.Normalized thyroid and prolactin function tests.Age range18 to 40 years.BMI<30kg/m2,and1<AMH<3.5,Having at least one healthy fallopian tube and normal uterine cavity. Normalized semen fluid or mild oligospermia,.Exclusion criteria:No consent to participate in the study.Poor Response patients(AMH<1ng/dl) Disturbance thyroid function and high prolactin.double blocked fallopian tubes or hydrosalpinx,and those with polycystic ovarian disease(PCOD)
Intervention groups
receiveing or not receiving endometer scratch using paipel divided into two groups of control and scratch
Main outcome variables
Comparison of success rate of pregnancy in the two groups

General information

Reason for update
Change in the inclusion and exclusion criteria to increase accuracy in selected sample cases of study and change in the number of sample and change in the time of study due to the large number of samples and prolonged duration of sampling
Acronym
IRCT registration information
IRCT registration number: IRCT20180731040659N1
Registration date: 2018-09-03, 1397/06/12
Registration timing: prospective

Last update: 2021-03-06, 1399/12/16
Update count: 2
Registration date
2018-09-03, 1397/06/12
Registrant information
Name
Farzaneh Khastefekr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5631
Email address
farzanehkhastefekr@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-10, 1398/02/20
Expected recruitment end date
2019-11-28, 1398/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of local scratch of endometrium on the outcome of pregnancy in women with the previous failure of intrauterine insemination
Public title
Effect of local scratch of endometrium on the outcome of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria of the study were:infertility women with one or two history of failure in IUI or IO who are planning to have a pregnancy and are candidates for IUI despite proper ovolation and primary and secondary infirtility with having at least one patent fallopian tube,women eged18_40years BMI<30kg/m2and1<AMH<3.5with normal thyroid and prolactin funtional tests،normal semen analysis,and mild oligospermia
Exclusion criteria:
Exclusion criteria,. No consent to participate in the study, Poor Response patients(AMH<1ng/dl) Disturbance of thyroid function and high prolactin, double blocked fallopian tubes or hydrosalpinx), People with polycystic ovary disease(PCOD)
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 336
Randomization (investigator's opinion)
Not 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
Ethics Committee,Dental Collage
Street address
Persian Goulf Blvd,Aliibn Abitalib Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Approval date
2018-06-17, 1397/03/27
Ethics committee reference number
IR.ZAUMS.REC.1397.144

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pregnancy
Timepoint
On the 14th day after IUI, the biochemical pregnancy rate is measured
Method of measurement
Serum pregnancy test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: on based receiving or no receiving endometrial scratch using paipel is divided
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
infertility clinic of Ali Ibn Abi Talib in Zahedan
Full name of responsible person
Farahnaz Farzaneh
Street address
Perian gulf ,Blvd.Ali Ebne abitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5631
Email
Farahnaz1826@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Persian Goulf Blvd,Aliebnabitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5631
Email
Farahnaz1826@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
The University of Zahedan
Full name of responsible person
Farzaneh Khasteh Fekr
Position
Gynecology Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Blvd,persian gulf,Ali ebn abitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
7969155669
Phone
+98 54 3329 5631
Email
behzadahmadi27@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of of medical science Zahedan
Full name of responsible person
Farahnaz,Farzaneh
Position
Infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Infertility
Street address
Persian gulf,Blvd,Ali ebn abitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5631
Email
Farahnaz1826@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Farzaneh
Position
Infertility fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Persian Goulf Blvd,AliebnAbitaleb Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5631
Email
Farahnaz1826@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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