The effect of long term Gnrh agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis in avecinna infertility center in 2 018_2019
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Protocol summary
Determination of the effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with endometriosis
Determination of the effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis
Determination of the effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with endometriosisadenomyosis
تعیین اثر آگونیست طولانی مدت Gnrh قبل از انتقال جنین فریز شده در نتایج بارداری در زنان مبتلا به اندومتریوزیس
تعیین اثر آگونیست طولانی مدت Gnrh قبل از انتقال جنین فریز شده در نتایج بارداری در زنان مبتلا به آدنومیوزیس
تعیین اثر آگونیست طولانی مدت Gnrh قبل از انتقال جنین فریز شده در نتایج بارداری در زنان مبتلا به اندومتریوزیسآدنومیوزیس
Inclusion criteria: having at least 2 criteria in sonography; age between 20 to 40 years old; the candidate for frozen embryo transfer; the embryo has a quality A or blastocyst. Exclusion criteria: recurrent abortion; azospermia in sperm analysis of male partner; uncontrolled medical condition, abnormal karyotype, Uterine abnormal anatomy; immune and coagulation dysfunction; using immune suppressive medications; using immune suppressive medications; using another treatments for improvement of fertility success rate.
Inclusion criteria: having at least 2 criteria in sonography; age between 20 to 40 years old; the candidate for frozen embryo transfer; the embryo has a quality A or blastocyst. exclusion criteria: recurrent miscarriage, azoospermia in male partner, using alternative infertility treatment services (such as donation), uncontrolled underlying diseases such as diabetes, hypertension, kidney dysfunction, lupus, and untreated thyroid dysfunction, abnormal karyotype, anatomical disorder of the uterus (such as Mullerian anomaly, submucosal myoma with compression effect), thrombophilia, candidate of using any immunosuppressive or immunomodulatory drugs and interventions such as endometrial scratch or Platelet-Rich Plasma.
Inclusion criteria: having at least 2 criteria in sonography; age between 20 to 40 years old; the candidate for frozen embryo transfer; the embryo has a quality A or blastocyst. Exclusionexclusion criteria: recurrent abortion; azospermiamiscarriage, azoospermia in sperm analysis of male partner;, using alternative infertility treatment services (such as donation), uncontrolled medical conditionunderlying diseases such as diabetes, hypertension, kidney dysfunction, lupus, and untreated thyroid dysfunction, abnormal karyotype, Uterine abnormal anatomy; immuneanatomical disorder of the uterus (such as Mullerian anomaly, submucosal myoma with compression effect), thrombophilia, candidate of using any immunosuppressive or immunomodulatory drugs and coagulation dysfunction; using immune suppressive medications; using immune suppressive medications; using another treatments for improvement of fertility success rateinterventions such as endometrial scratch or Platelet-Rich Plasma.
معیارهای ورود: داشتن حداقل 2 معیار سونوگرافیک آدنومیوز،سن بین 20 تا 40 سال
کاندید انتقال جنین فریز باشد، جنین با کیفیت A یا بلاستوسیست داشته باشد. معیارهای خروج :سقط مکرر، آزواسپرمی در اسپرم آنالیز همسر، استفاده از خدمات درمان ناباروری جایگزین(اهدا)
شرایط پزشکی غیرقابل کنترل، کاریوتایپ غیر طبیعی، اختلال آناتومیکی رحم، اختلال ایمنی و کواگولیشن، استفاده از داروهای سرکوب کننده ایمنی، استفاده از درمان های دیگر برای بهبود نرخ بارداری
معیارهای ورود: داشتن حداقل 2 معیار سونوگرافیک آدنومیوز،سن بین 20 تا 40 سال
کاندید انتقال جنین فریز باشد، جنین با کیفیت A یا بلاستوسیست داشته باشد. معیارهای خروج :سقط مکرر، آزواسپرمی در همسر، استفاده از خدمات درمان ناباروری جایگزین (مانند اهدا)، بیماریهای اساسی کنترل نشده (مانند دیابت، فشارخون بالا، نارسایی کلیه، لوپوس و اختلال عملکرد تیروئید درمان نشده)، کاریوتیپ غیرطبیعی، اختلال آناتومیک رحم (مانند آنومالی مولرین، میوم ساب موکوز با اثر فشاری)، ترومبوفیلی، استفاده از داروهای سرکوبگر یا تنظیم کننده ایمنی و مداخلاتی مانند خراش اندومتر یا پلاسمای غنی از پلاکت.
معیارهای ورود: داشتن حداقل 2 معیار سونوگرافیک آدنومیوز،سن بین 20 تا 40 سال کاندید انتقال جنین فریز باشد، جنین با کیفیت A یا بلاستوسیست داشته باشد. معیارهای خروج :سقط مکرر، آزواسپرمی در اسپرم آنالیز همسر، استفاده از خدمات درمان ناباروری جایگزین(اهداجایگزین (مانند اهدا) شرایط پزشکی غیرقابل، بیماریهای اساسی کنترل نشده (مانند دیابت، کاریوتایپ غیر طبیعیفشارخون بالا، نارسایی کلیه، لوپوس و اختلال عملکرد تیروئید درمان نشده)، کاریوتیپ غیرطبیعی، اختلال آناتومیکیآناتومیک رحم (مانند آنومالی مولرین، اختلال ایمنی و کواگولیشنمیوم ساب موکوز با اثر فشاری)، ترومبوفیلی، استفاده از داروهای سرکوبسرکوبگر یا تنظیم کننده ایمنی، استفاده و مداخلاتی مانند خراش اندومتر یا پلاسمای غنی از درمان های دیگر برای بهبود نرخ بارداریپلاکت.
Pregnancy rate
Chemical and clinical pregnancy rate
PregnancyChemical and clinical pregnancy rate
میزان بارداری
میزان بارداری شیمایی و بالینی
میزان بارداری شیمایی و بالینی
General information
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2020-02-29, 1398/12/10
2021-02-28, 1399/12/10
20202021-02-2928 00:00:00
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2019-03-01, 1397/12/10
2019-03-01 00:00:00
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2021-09-01, 1400/06/10
2021-09-01 00:00:00
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2021-09-01, 1400/06/10
2021-09-01 00:00:00
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The trial end date was entered and the final volume of the sample was entered.
The trial end date was entered and the final volume of the sample was entered.
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تاریخ پایان کارآزمایی درج گردید و حجم نهایی نمونه وارد شد
تاریخ پایان کارآزمایی درج گردید و حجم نهایی نمونه وارد شد
Protocol summary
Study aim
Determination of the effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis
Design
Clinical trial with control group
Settings and conduct
Avecinna infertility center
Participants/Inclusion and exclusion criteria
Inclusion criteria: having at least 2 criteria in sonography; age between 20 to 40 years old; the candidate for frozen embryo transfer; the embryo has a quality A or blastocyst. exclusion criteria: recurrent miscarriage, azoospermia in male partner, using alternative infertility treatment services (such as donation), uncontrolled underlying diseases such as diabetes, hypertension, kidney dysfunction, lupus, and untreated thyroid dysfunction, abnormal karyotype, anatomical disorder of the uterus (such as Mullerian anomaly, submucosal myoma with compression effect), thrombophilia, candidate of using any immunosuppressive or immunomodulatory drugs and interventions such as endometrial scratch or Platelet-Rich Plasma.
Intervention groups
The intervention group will receive the GnRH agonist for 3 months.
Main outcome variables
Chemical and clinical pregnancy rate
General information
Reason for update
The trial end date was entered and the final volume of the sample was entered.
Acronym
IRCT registration information
IRCT registration number:IRCT20160717028967N9
Registration date:2019-01-01, 1397/10/11
Registration timing:prospective
Last update:2023-07-27, 1402/05/05
Update count:2
Registration date
2019-01-01, 1397/10/11
Registrant information
Name
Safora Salemi
Name of organization / entity
Shahid Chamran University of Ahvaz
Country
Iran (Islamic Republic of)
Phone
+98 83 3821 1001
Email address
e.mahmoudi@cobeldarou.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
2019-03-01, 1397/12/10
Actual recruitment end date
2021-09-01, 1400/06/10
Trial completion date
2021-09-01, 1400/06/10
Scientific title
The effect of long term Gnrh agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis in avecinna infertility center in 2 018_2019
Public title
The effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 2 criteria in sonography
Age between 20 to 40 years old
The candidate for frozen embryo transfer
The embryo has a quality A or blastocyst
Exclusion criteria:
Recurrent abortion
Azospermia in sperm analysis of male partner
Uncontrolled medical condition
Abnormal karyotype
Uterine abnormal anatomy
Immune and coagulation dysfunction
Using immune suppressive medications
Using immune suppressive medications
Using another treatments for improvement of fertility success rate
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two equal groups (A and B) based on a randomized six-block table that is designed by Random allocation software.
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 of Avecinna infertility center
Street address
No 97, Yakhchal junction, Shariati street, Avecinna infertility center.
City
Tehran
Province
Tehran
Postal code
1941913114
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1397.015
Health conditions studied
1
Description of health condition studied
People with Adenomyosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Pregnancy rate
Timepoint
14 and 16 days after embryo transfer
Method of measurement
Beta test
2
Description
Clinical pregnancy rate
Timepoint
6th week of pregnancy
Method of measurement
With sonography
3
Description
Ongoing pregnancy rate
Timepoint
7th week of pregnancy
Method of measurement
With sonography
4
Description
Abortion rate before 12 weeks
Timepoint
12th week of pregnancy
Method of measurement
With sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The GnRH agonist group treated with a 11.25 mg intramuscular Triptorelin in the 3th menstural cycle day and after 12 weeks hormone replacement therapy starts with estradiol valerate. Then subjects will be followed with serial transvaginal ultrasound and after reaching to the endometrial thickness of 7 mm, progesterone will be added to the treatment and after 3 to 5 days embryo transfer will be performed.
Category
Treatment - Drugs
2
Description
Control group: In the control group the standard treatment begins with a 21 days of low dose contraceptives from the 3th day of the menstural cycle and a 1.875 mg intramuscular dose of Triptorelin in the 21th day of menstural cycle and the hormone replacement therapy starts with estradiol valerate in the next menstural cycle. Then subjects will be followed with serial transvaginal ultrasound and after reaching to the endometrial thickness of 7 mm, progesterone will be added to the treatment and after 3 to 5 days embryo transfer will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Avecinna infertility center
Full name of responsible person
Soheila Ansaripour
Street address
Yakhchal junction, Shariati street, Avecinna infertility center, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
Soh.ansaripour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Avicenna infertility center
Full name of responsible person
Sharare Shafiei
Street address
No 97, Yakhchal junction, Shariati street, Avicenna infertility center,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
sh.shafiei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Avicenna infertility center
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
Avecinna infertility center
Full name of responsible person
Dr. Soheila Ansaripour
Position
Assistant professor of infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 97, Yakhchal junction, Shariati street, Avecinna infertility center,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 0982123519
Email
Soh.ansaripour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Avicenna infertility center
Full name of responsible person
Dr. Soheila Ansaripour
Position
Assistant professor of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 97, Yakhchal junction, Shariati street, Avicenna infertility center,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
Soh.ansaripour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Avicenna infertility center
Full name of responsible person
Katayoun Yazdchi
Position
Assistant professor of infertility
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 97, Yakhchal junction, Shariati street, Avicenna infertility center,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 0982123519
Email
katayounyazdchi@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
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
Title and more details about the data/document
I have no plans at this time
When the data will become available and for how long
I have no plans at this time
To whom data/document is available
I have no plans at this time
Under which criteria data/document could be used
I have no plans at this time
From where data/document is obtainable
I have no plans at this time
What processes are involved for a request to access data/document