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Influence of growth hormone supplementation on pregnancy outcome of patients undergoing frozen thawed embryo transfer(FET)

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History
# Registration date Revision Id
2 2020-09-11, 1399/06/21 151058
1 2020-03-02, 1398/12/12 123933
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  • Protocol summary

    two arm parallel 50 patients group quasi randomized through visited day as odd or even
    non randomized 2 arm parallel group with 50 patients
    کارازمایی بالینی دارای گروه کنترل با ۲ گروه موازی ۵۰ نفره و شبه تصادفی شده با روز مراجعه به صورت زوج و فرد
    کارازمایی بالینی غیرتصادفی دارای گروه کنترل با ۲ گروه موازی ۵۰ نفره
    Endometrial preparation will be done from second day of cycle with 6mg daily estradiol in patient who are candidate for frozen thawed embryo transfer and serial sonography will be done from 12th day of cycle ;when thickness reaches 7mm or more and patients have including criteria they will divided into 2 groups through visited day as odd or even ;in control group we just prescribe 400mg daily progesterone for 3 days and in case group they will receive 1.2 mg growth hormone along with 400mg progesterone.72 hours later all pateints will be transferred maximum 2 cleaved embryo; serum BHCG wil be checked 2weeks later and if it is positive, vaginal sonography must be done for identification of gestational sac with fetal heart beat.
    Endometrial preparation will be done from second day of cycle with 6mg daily estradiol in patient who are candidate for frozen thawed embryo transfer and serial sonography will be done from 12th day of cycle ;when thickness reaches 7mm or more and patients have including criteria they will divided into 2 groups ;in control group we just prescribe 400mg daily progesterone for 3 days and in case group they will receive 1.2 mg growth hormone along with 400mg progesterone.72 hours later all pateints will be transferred maximum 2 cleaved embryo; serum BHCG wil be checked 2weeks later and if it is positive, vaginal sonography must be done for identification of gestational sac with fetal heart beat.
    در بیمارانی که کاندید انتقال جنین در سیکل برگشت از فریز هستند جهت اماده سازی اندومتر از روز دوم سیکل قاعدگی روزانه ۶ میلیگرم استرادیول دریافت میکنند و از روز ۱۲ سیکل قاعدگی سونوگرافی سریال بررسی ضخامت اندومتر انجام میشود .در صورتی که ضخامت اندومتر ۷میلیمتر یا بیشتر باشد و بیماران شرایط ورود به مطالعه را داشته باشند به صورت شبه تصادفی بر اساس روز مراجعه زوج یا فرد به دو گروه تقسیم میشوند. گروه مورد شامل ۵۰ نفر و گروه شاهد۵۰ نفر هستند.در گروه مورد علاوه بر ۴۰۰ میلیگرم شیاف پروژسترون دو نوبت در روز ، 1.2میلیگرم هورمون رشد روزانه به صورت زیر جلدی داده میشود و گروه شاهد فقط ۴۰۰ میلیگرم شیاف پروژسترون دو نوبت در روز دریافت میکنند و ۷۲ ساعت بعد حداکثر ۲ عدد جنین در مرحله کلیواژ منتقل میشود و از بیماران ۲ هفته بعد از انتقال تست بارداری گرفته میشود و ۲ هفته بعد از مثبت شدن تست بارداری سونوگرافی ترانس واژینال جهت بررسی ساک حاملگی و تشکیل قلب جنین انجام میشود.
    در بیمارانی که کاندید انتقال جنین در سیکل برگشت از فریز هستند جهت اماده سازی اندومتر از روز دوم سیکل قاعدگی روزانه ۶ میلیگرم استرادیول دریافت میکنند و از روز ۱۲ سیکل قاعدگی سونوگرافی سریال بررسی ضخامت اندومتر انجام میشود .در صورتی که ضخامت اندومتر ۷میلیمتر یا بیشتر باشد و بیماران شرایط ورود به مطالعه را داشته باشند به صورت غیرتصادفی دو گروه تقسیم میشوند. گروه مورد شامل ۵۰ نفر و گروه شاهد۵۰ نفر هستند.در گروه مورد علاوه بر ۴۰۰ میلیگرم شیاف پروژسترون دو نوبت در روز ، 1.2میلیگرم هورمون رشد روزانه به صورت زیر جلدی داده میشود و گروه شاهد فقط ۴۰۰ میلیگرم شیاف پروژسترون دو نوبت در روز دریافت میکنند و ۷۲ ساعت بعد حداکثر ۲ عدد جنین در مرحله کلیواژ منتقل میشود و از بیماران ۲ هفته بعد از انتقال تست بارداری گرفته میشود و ۲ هفته بعد از مثبت شدن تست بارداری سونوگرافی ترانس واژینال جهت بررسی ساک حاملگی و تشکیل قلب جنین انجام میشود.

  • Recruitment centers

    #1
    Name of recruitment center - English: research and clinical center for infertility(Yazd reproductive sciences Institute)
    Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری(پژوهشکده علوم تولید مثل یزد)
    Full name of responsible person - English: dr.robab davar
    Full name of responsible person - Persian: دکتر رباب داور
    Street address - English: Yazd,safaeiyeh,bouali ave.
    Street address - Persian: یزد صفاییه خیابان بوعلی
    City - English: yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: ۸۹۱۶۸۷۷۳۹۱
    Phone: +98 35 3824 7085
    Fax:
    Email: info@yazd-rsi.ir
    Web page address:
    Name of recruitment center - English: Research and Clinical Center for Infertility(Yazd Reproductive Sciences Institute)
    Name of recruitment center - Persian: مرکز تحقیقاتی و درمانی ناباروری(پژوهشکده علوم تولید مثل یزد)
    Full name of responsible person - English: Dr.Robab Davar
    Full name of responsible person - Persian: دکتر رباب داور
    Street address - English: Yazd,Safaeiyeh,Bouali ave.
    Street address - Persian: یزد صفاییه خیابان بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: ۸۹۱۶۸۷۷۳۹۱
    Phone: +98 35 3824 7085
    Fax:
    Email: info@yazd-rsi.ir
    Web page address:

Protocol summary

Study aim
Influence of growth hormone supplementation on pregnancy outcome of frozen thawed embryo transfer cycle(FET)
Design
non randomized 2 arm parallel group with 50 patients
Settings and conduct
Endometrial preparation will be done from second day of cycle with 6mg daily estradiol in patient who are candidate for frozen thawed embryo transfer and serial sonography will be done from 12th day of cycle ;when thickness reaches 7mm or more and patients have including criteria they will divided into 2 groups ;in control group we just prescribe 400mg daily progesterone for 3 days and in case group they will receive 1.2 mg growth hormone along with 400mg progesterone.72 hours later all pateints will be transferred maximum 2 cleaved embryo; serum BHCG wil be checked 2weeks later and if it is positive, vaginal sonography must be done for identification of gestational sac with fetal heart beat.
Participants/Inclusion and exclusion criteria
including criteria:20-40 years old infertile patient who will transfered frozen thawed embryo and have adequate endometrial thickness excluding criteria: uterus malformation or adhesion, sever andometriosis or adenomyosis and recurrent implantation failure
Intervention groups
20-40 years old infertile woman who are candidate for frozen thawed embryo transfer and have appropriate endometrium received 1.2 mg daily growth hormone along with progesterone
Main outcome variables
chemical pregnancy; clinical pregnancy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091018002604N5
Registration date: 2020-03-02, 1398/12/12
Registration timing: retrospective

Last update: 2020-09-16, 1399/06/26
Update count: 1
Registration date
2020-03-02, 1398/12/12
Registrant information
Name
Robab Davar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
davar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-02-03, 1398/11/14
Actual recruitment start date
2019-09-22, 1398/06/31
Actual recruitment end date
2020-02-03, 1398/11/14
Trial completion date
2020-03-04, 1398/12/14
Scientific title
Influence of growth hormone supplementation on pregnancy outcome of patients undergoing frozen thawed embryo transfer(FET)
Public title
Influence of adding growth hormone in frozen embryo transfer cycle outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-40 years old infertile patient candidate for frozen thawed embryo transfer
Exclusion criteria:
uterus malformation-sever endometriosis and adenomyosis-uterus adhesion-recurrent implantation failure
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
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 of Research and Clinical Center for Infertility(Yazd Reproductive Sciences Institut
Street address
Research and Clinical Center for Infertility, BouAli avenue, Safaieye
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.SSU.RSI.REC.1398.025

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
chemical pregnancy
Timepoint
2weeks after embryo transfer
Method of measurement
serum BHCG

Secondary outcomes

1

Description
clinical pregnancy
Timepoint
2weeks after positive BHCG
Method of measurement
vaginal sonography

Intervention groups

1

Description
Intervention group:Endometrial preparation will be done for 20-40 years old infertile woman who are candidate for frozen thawed embryo transfer from second day of cycle with 6 mg daily estradiol and serial sonography will be done from 12th day of cycle ;when thickness reaches 7 mm ,they receive 1.2 mg daily growth hormone along with 400 mg progesterone for 3 days and then embryo transfer will be done.
Category
Treatment - Drugs

2

Description
Control group: :Endometrial preparation will be done for 20-40 years old infertile woman who are candidate for frozen thawed embryo transfer from second day of cycle with 6 mg daily estradiol and serial sonography will be done from 12th day of cycle ;when thickness reaches 7 mm ,they receive 400 mg progesterone for 3 days and then embryo transfer will be done.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility(Yazd Reproductive Sciences Institute)
Full name of responsible person
Dr.Robab Davar
Street address
Yazd,Safaeiyeh,Bouali ave.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
info@yazd-rsi.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Sadoughi University of Medical Science,Yazd,Iran
Full name of responsible person
Robab davar
Street address
Safaeiye-Bouali ave-Research and Clinical Center for Infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7086
Email
info@yazd-rsi.ir
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,Shahid Sadoughi University of Medical Science,Yazd,Iran
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
Research and Clinical Center forInfertility، Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Robab Davar M.D.
Position
Obstetrician and Gynecologist ،Infertility and IVF Fellowship(Professor)
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, BouAli aven, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
davar@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Robab Davar M.D.
Position
Obstetrician and Gynecologist,Infertility Fellowship (professor)
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bou Ali aven, Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 1824 7087
Email
davar@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Yasamin Mehrolhasani
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
yasamin_m@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information exist
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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