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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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History
# Registration date Revision Id
3 2023-06-27, 1402/04/06 273176
2 2019-01-01, 1397/10/11 73678
1 2019-01-01, 1397/10/11 73314
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  • Protocol summary

    تعیین اثر آگونیست طولانی مدت Gnrh قبل از انتقال جنین فریز شده در نتایج بارداری در زنان مبتلا به آدنومیز
    تعیین اثر آگونیست طولانی مدت Gnrh قبل از انتقال جنین فریز شده در نتایج بارداری در زنان مبتلا به اندومتریوزیس

  • General information

    The effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with endometriosis
    The effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis
    The effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with endometriosis in Avicenna infertility center in 2‌‌018_2019
    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

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Avicenna infertility center
    Name of organization / entity - Persian: مرکز ناباروی ابن سینا
    Full name of responsible person - English: Dr. Soheila Ansaripour
    Full name of responsible person - Persian: دکتر سهیلا انصاری پور
    Street address - English: No 97, Yakhchal junction, Shariati street, Avicenna infertility center,Tehran, Iran.
    Street address - Persian: ایران، تهران، خیابان شریعتی، نبش خیابان یخچال، پلاک نود و هفت، مرکز ناباروی ابن سینا
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1941913114
    Phone: +98 21 23519
    Fax:
    Email: name@domain.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Avicenna infertility center
    Name of organization / entity - Persian: معاونت پژوهشی، مرکز ناباروی ابن سینا
    Full name of responsible person - English: Sharare Shafiei
    Full name of responsible person - Persian: شراره شفیعی
    Street address - English: No 97, Yakhchal junction, Shariati street, Avicenna infertility center,Tehran, Iran.
    Street address - Persian: ایران، تهران، خیابان شریعتی، نبش خیابان یخچال، پلاک نود و هفت، مرکز ناباروی ابن سینا
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1941913114
    Phone: +98 21 23519
    Fax:
    Email: sh.shafiei@yahoo.com
    Web page address:

Protocol summary

Study aim
Determination of the effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with endometriosis
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 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.
Intervention groups
The intervention group will receive the GnRH agonist for 3 months.
Main outcome variables
Pregnancy rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160717028967N9
Registration date: 2019-01-01, 1397/10/11
Registration timing: prospective

Last update: 2019-01-03, 1397/10/13
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
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
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
I have no plans at this time
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