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Investigation of gene expression and secretion of P53, LIF, IL_10, IL-17 after administration of tacrolimus in endometrial and uterine fluid in patients with repeated implantation failure: Clinical trial

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History
# Registration date Revision Id
2 2018-01-11, 1396/10/21 32929
1 2017-11-29, 1396/09/08 28399
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  • Protocol summary

    1.Evaluate the effect of Tacrolimus on gene expression of P-53, IL-10, IL-17 and LIF in endometrial sample 2.Evaluate the effect of Tacrolimus on level of secretion of P-53, IL-10, IL-17 and LIF in endometrial sample 3.Evaluate the effect of Tacrolimus on level of u-NK-cell in endometrial sample 4.Evaluate the effect of Tacrolimus on chemical pregnancy rate, implantation rate and live birth rate
    1.Evaluate the effect of Tacrolimus on gene expression of P53, IL-10, IL-17 and LIF in endometrial sample 2.Evaluate the effect of Tacrolimus on level of secretion of IL-10, IL-17 and LIF in endometrial fluid 3. Evaluate the effect of Tacrolimus on level of secretion of P53 IL-10, IL-17 and LIF in endometrial sample 4.Evaluate the effect of Tacrolimus on level of u-NK-cell in endometrial sample 5.Evaluate the effect of Tacrolimus on chemical pregnancy rate, implantation rate and live birth rate
    1.تعیین اثر داروی تاکرولیموس در بیان ژن های LIF و P53 و IL-17 و IL-10 در نمونه اندومتر 2.تعیین اثر داروی تاکرولیموس در میزان LIF و P53 و IL-17 و IL-10 در نمونه مایع رحمی 3.تعیین اثر داروی تاکرولیموس در میزان u-NK-cell در نمونه اندومتر 4.تعیین اثر داروی تاکرولیموس در میزان حاملگی شیمیایی ، میزان لانه گزینی و میزان تولد زنده
    1.تعیین اثر داروی تاکرولیموس در بیان ژن های LIF و P53 و IL-17 و IL-10 در نمونه اندومتر 2.تعیین اثر داروی تاکرولیموس در میزان LIF و IL-17 و IL-10 در نمونه مایع رحمی 3.تعیین اثر داروی تاکرولیموس در میزان LIF و P53 و IL-17 و IL-10 در نمونه اندومتر 4.تعیین اثر داروی تاکرولیموس در میزان u-NK-cell در نمونه اندومتر 5.تعیین اثر داروی تاکرولیموس در میزان حاملگی شیمیایی ، میزان لانه گزینی و میزان تولد زنده

  • General information

    3
    2
    7
    10

  • Secondary outcomes

    #1
    level of P53 protein in uterine fluide
    Biochemical Pregnancy Rate
    میزان پروتئین p53 در مایع رحمی
    میزان حاملگی شیمیایی
    Measure twice: before and after treatment
    Two weeks after embryo transfer
    دوبار: قبل و بعد از مداخله
    دو هفته بعد از انتقال جنین
    ELISA
    Level of B-HCG in blood
    الایزا
    میزان B-HCG در خون
    #2
    Biochemical Pregnancy Rate
    Live Birth Rate
    میزان حاملگی شیمیایی
    میزان تولد زنده
    Two weeks after embryo transfer
    Nine months after embryo transfer
    دو هفته بعد از انتقال جنین
    نه ماه پس از انتقال جنین
    Level of B-HCG in blood
    Number of newborns
    میزان B-HCG در خون
    تعداد نوزادان متولد شده
    #3
    Live Birth Rate
    Embryo implantation Rate
    میزان تولد زنده
    لانه گزینی جنین
    Nine months after embryo transfer
    Two weeks after a chemical pregnancy confirmation
    نه ماه پس از انتقال جنین
    دوهفته بعد از تایید حاملگی شیمیایی
    Number of newborns
    Observation of Pregnancy Sac by Ultrasound
    تعداد نوزادان متولد شده
    رویت ساک حاملگی توسط سونوگرافی
    #4
    Embryo implantation Rate
    Blood level of Estradiol
    لانه گزینی جنین
    سطح استروژن خون
    Two weeks after a chemical pregnancy confirmation
    Measure twice: before and after treatment
    دوهفته بعد از تایید حاملگی شیمیایی
    دوبار: قبل و بعد از مداخله
    Observation of Pregnancy Sac by Ultrasound
    Measurement in blood
    رویت ساک حاملگی توسط سونوگرافی
    سنجش در نمونه خون
    #5
    Blood level of Estradiol
    Blood level of Progestron
    سطح استروژن خون
    سطح پروژسترون خون
    #6
    Blood level of Progestron
    P53 protein level in endometrium
    سطح پروژسترون خون
    میزان پروتئین P53 در نمونه اندومتر
    Measurement in blood
    immunohistochemistry
    سنجش در نمونه خون
    ایمونو هیستو شیمی
    #7
    empty
    LIF protein level in endometrium
    empty
    میزان پروتئین LIF در نمونه اندومتر
    empty
    Measure twice: before and after treatment
    empty
    دوبار: قبل و بعد از مداخله
    empty
    immunohistochemistry
    empty
    ایمونو هیستو شیمی
    #8
    empty
    IL-10 protein level in endometrium
    empty
    میزان پروتئین IL-10 در نمونه اندومتر
    empty
    Measure twice: before and after treatment
    empty
    دوبار: قبل و بعد از مداخله
    empty
    immunohistochemistry
    empty
    ایمونو هیستو شیمی
    #9
    empty
    IL-17 protein level in endometrium
    empty
    میزان پروتئین IL-17 در نمونه اندومتر
    empty
    Measure twice: before and after treatment
    empty
    دوبار: قبل و بعد از مداخله
    empty
    immunohistochemistry
    empty
    ایمونو هیستو شیمی

  • Recruitment centers

    #1
    Name of recruitment center - English: Department of Infertility, Alzahra Hospital
    Name of recruitment center - Persian: بخش ناباروری بیمارستان الزهرا
    Full name of responsible person - English: Zahra Bahrami Asl
    Full name of responsible person - Persian: زهرا بهرامی اصل
    Street address - English:
    Street address - Persian:
    City - English: Tabriz
    City - Persian: تبریز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Department of Infertility, Alzahra Hospital
    Name of recruitment center - Persian: بخش ناباروری بیمارستان الزهرا
    Full name of responsible person - English: Zahra Bahrami Asl
    Full name of responsible person - Persian: زهرا بهرامی اصل
    Street address - English: Al-zahra Hospital, South-Artesh Ave
    Street address - Persian: بیمارستان الزهرا، خیابان ارتش جنوبی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5138665793
    Phone: +98 41 3553 6197
    Fax:
    Email: dr.za.bahrami@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Dr Afshin Rezghi
    Full name of responsible person - Persian: دکتر افشین رزقی
    Street address - English: Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
    Street address - Persian: ولنجک، بلوار دانشجو، خیابان اعرابی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Dr Afshin Rezghi
    Full name of responsible person - Persian: دکتر افشین رزقی
    Street address - English: Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
    Street address - Persian: ولنجک، بلوار دانشجو، خیابان اعرابی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1985717443
    Phone: +98 21 2387 2577
    Fax:
    Email: dr.za.bahrami@gmail.com
    Web page address:

Protocol summary

Study aim
1.Evaluate the effect of Tacrolimus on gene expression of P53, IL-10, IL-17 and LIF in endometrial sample 2.Evaluate the effect of Tacrolimus on level of secretion of IL-10, IL-17 and LIF in endometrial fluid 3. Evaluate the effect of Tacrolimus on level of secretion of P53 IL-10, IL-17 and LIF in endometrial sample 4.Evaluate the effect of Tacrolimus on level of u-NK-cell in endometrial sample 5.Evaluate the effect of Tacrolimus on chemical pregnancy rate, implantation rate and live birth rate
Design
In this research, as a first phase of study, 7 eligible patients referring to Al-Zahra Hospital were chosen purposefully.Implantation factors in endometrial and uterine fluid were assessed before and after treatment and finally pregnancy outcomes will be reviewed.
Settings and conduct
Al-Zahra Hospital
Participants/Inclusion and exclusion criteria
patients who have at least three-time implantation failure and normal karyotype and have no anatomical problems, autoimmune disease and clotting disorders and have no history of abortion.
Intervention groups
1. Endometrial sample and uterine fluid are taken in the first menstrual cycle 2.prescription of Tacrolimus and endometrial sample and uterine fluid are taken in the second menstrual cycle 3.prescription of Tacrolimus and embryo transfer
Main outcome variables
1.Gene expression of P-53, IL-10, IL-17 and LIF in endometrial sample 2. Level of secretion of P-53, IL-10, IL-17 and LIF in endometrial sample 3.Level of u-NK-cell in endometrial sample 4. Chemical pregnancy rate, implantation rate and live birth rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171007036623N1
Registration date: 2017-11-29, 1396/09/08
Registration timing: prospective

Last update: 2018-01-12, 1396/10/22
Update count: 1
Registration date
2017-11-29, 1396/09/08
Registrant information
Name
zahra Bahrami asl
Name of organization / entity
Shahid Beheshti university
Country
Iran (Islamic Republic of)
Phone
+98 21 2387 2577
Email address
za.bahrami@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Science
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-04-22, 1397/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of gene expression and secretion of P53, LIF, IL_10, IL-17 after administration of tacrolimus in endometrial and uterine fluid in patients with repeated implantation failure: Clinical trial
Public title
The Effect of Tacrolimus in patients with recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of 3 or more failed IVF/ET cycles with morphologically and developmentally average to good-quality embryo( 7 or more blastomeres and less than 10% fragmentation in day 3 ) into an adequately prepared endometrium (endometrial thickness equal or more than 8 mm); Women who had regular menses (25 to 35 days); Women who had normal karyotype; women who had at least one of these Immunological disorders in their peripheral blood sample between day of 5 to 10 of menstrual cycle: IFN-g/IL-4 equal or more than 10.3 or Nk-cell percentage greater than 12%
Exclusion criteria:
Present of sub mucosal fibroids, endometrial polyps, intrauterine adhesions, congenital anomalies of uterus or hydrosalpinges History of active autoimmune disease (With assessment of ANA, Anti-TG, Anti-TPO, Anti-dsDNA); Women with acquired or inherited thrombophilia (With assessment of Factor2, Factor5, Factor 8, Fibrinogen, Anti- Cardiolipin, Anti-Phospholipid Antibody, Lupus Anti-Coagulate, s-MTHFR gene) Pregnant women; History of miscarriage in a former IVF/ET cycle; Women who received vaccine in the last three months; Women who received steroid hormones in the last 2 months; Women receiving immunotherapy; Women with chronic inflammatory diseases
Age
From 20 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
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
Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
198396-3113
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.SBMU. MSP.REC.1395. 580

Health conditions studied

1

Description of health condition studied
Recurrent Implantation Failure
ICD-10 code
N-97.2
ICD-10 code description
Female infertility of uterin

Primary outcomes

1

Description
Expression of P53 gene
Timepoint
Measure twice: before and after treatment
Method of measurement
qRT-PCR

2

Description
Expression of LIF gene
Timepoint
Measure twice: before and after treatment
Method of measurement
qRT-PCR

3

Description
Expression of IL-10 gene
Timepoint
Measure Twice: before and after treatment
Method of measurement
qRT-PCR

4

Description
Expression of IL-17 gene
Timepoint
Measure twice: before and after treatment
Method of measurement
qRT-PCR

Secondary outcomes

1

Description
LIF protein levels in uterine fluid
Timepoint
Measure twice: before and after treatment
Method of measurement
ELISA

2

Description
Level Of IL-10 protein in uterine fluid
Timepoint
Measure twice: before and after treatment
Method of measurement
ELISA

3

Description
Level Of IL-17 protein in uterine fluid
Timepoint
Measure twice: before and after treatment
Method of measurement
ELISA

4

Description
Biochemical Pregnancy Rate
Timepoint
Two weeks after embryo transfer
Method of measurement
Level of B-HCG in blood

5

Description
Live Birth Rate
Timepoint
Nine months after embryo transfer
Method of measurement
Number of newborns

6

Description
Embryo implantation Rate
Timepoint
Two weeks after a chemical pregnancy confirmation
Method of measurement
Observation of Pregnancy Sac by Ultrasound

7

Description
Blood level of Estradiol
Timepoint
Measure twice: before and after treatment
Method of measurement
Measurement in blood

8

Description
Blood level of Progestron
Timepoint
Measure twice: before and after treatment
Method of measurement
Measurement in blood

9

Description
P53 protein level in endometrium
Timepoint
Measure twice: before and after treatment
Method of measurement
immunohistochemistry

10

Description
LIF protein level in endometrium
Timepoint
Measure twice: before and after treatment
Method of measurement
immunohistochemistry

11

Description
IL-10 protein level in endometrium
Timepoint
Measure twice: before and after treatment
Method of measurement
immunohistochemistry

12

Description
IL-17 protein level in endometrium
Timepoint
Measure twice: before and after treatment
Method of measurement
immunohistochemistry

Intervention groups

1

Description
Prescription of Tacrolimus in the second menstrual cycle for up to 16 days (until 2 days before second biopsy) with 1-3 mg per day upon on IFN-g/IL-4 ratio: Prescription of 1 mg per day if this ratio is equal or more than10.3 and less than 13 Prescript
Category
Treatment - Drugs

2

Description
Prescription of Tacrolimus in third cycle of menstruation from 2 days before embryo transfer until 14 days after embryo transfer for overall 16 days with 1-3 mg per day upon on IFN-g/IL-4 ratio. Prescription of 1 mg per day if this ratio is equal or mo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Infertility, Alzahra Hospital
Full name of responsible person
Zahra Bahrami Asl
Street address
Al-zahra Hospital, South-Artesh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 6197
Email
dr.za.bahrami@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Rezghi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2577
Email
dr.za.bahrami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Bahrami Asl
Position
PhD student of reproductive biology
Latest degree
Medical doctor
Other areas of specialty/work
Reproductive Biology
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 23872555
Fax
Email
za.bahrami@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Marefat Gaffari Novin
Position
Professor of Reproductive Biology
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2577
Fax
Email
dr.za.bahrami@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra bahrami Asl
Position
PhD student of reproductive biology
Latest degree
Medical doctor
Other areas of specialty/work
Reproductive Biology
Street address
School of Medicine, Koodakyar St. Danshjoo Blv, Velenjak, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2577
Fax
Email
dr.za.bahrami@gmail.com
Web page address

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Share with other studies and collaborate with other research and clinical centers to increase the effectiveness of the study
When the data will become available and for how long
After the study is completed and 6 months after the results are printed
To whom data/document is available
Research Centers and Study Groups of Basic Sciences and Clinical Sciences
Under which criteria data/document could be used
It is possible to use the analyzed results after receiving written permission from the executor
From where data/document is obtainable
Principal Investigator or corresponding author of study
What processes are involved for a request to access data/document
After a written request for the use of results in clinical studies
Comments
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