The effects of Tacrolimus on pregnancy outcome in women with recurrent implantation failure (RIF) associated with immunologic factors: clinical trial
Design
Clinical trial with control group, with parallel group, double blind, randomized, phase 2 on 50 patients. A table of random numbers will be used for randomization.
Settings and conduct
This study is a clinical trial; First, written and informed consent will be received from people with RIF (50 people) who have a history of repeated implantation failure 3 times and have referred to Al-Zahra Infertility Center and Azerbaijan Infertility Center in Tabriz, and constitute our target population in this project.
Participants/Inclusion and exclusion criteria
In conducting this study, our important criteria for patients to enter the study include the following:
Since the genetics and race of each person are effective in the effectiveness of the drug, our patients will be selected only from Azari-speaking people.
Patients who do not have any type of immunotherapy in their medical history will be included in the study.
Our criteria for withdrawing patients from the study also include the following:
Patients under 18 years old and over 41 years old
Patients who themselves or their spouses have abnormal karyotypes or genetic and chromosomal disorders.
Patients with coagulation problems.
Patients who have an underlying chronic disease and have to take special drugs.
Patients with intrauterine anomalies.
Intervention groups
1 to 2 mg of tacrolimus drug is prescribed orally 2 days before the transfer and 14 days after the transfer, taking into account the activity of the immune system of the patients. We will compare the control group that did not receive any treatment (received routine treatments but did not receive tacrolimus).
Main outcome variables
Pregnancy rate
General information
Reason for update
Acronym
TPORIF
IRCT registration information
IRCT registration number:IRCT20160422027520N22
Registration date:2023-02-20, 1401/12/01
Registration timing:prospective
Last update:2023-02-20, 1401/12/01
Update count:0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Tacrolimus on pregnancy outcome in women with recurrent implantation failure (RIF) associated with immunologic factors: clinical trial
Public title
Investigating the effect of tacrolimus on fertility in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Disturbed ratio (Th1/Th2)
Patients who have experienced at least 3 consecutive implantation failures will be included in our study.
Patients who do not have any type of immunotherapy in their medical history will be included in the study.
Exclusion criteria:
Patients under 18 years old and over 41 years oldPatients who themselves or their spouses have abnormal karyotypes or genetic and chromosomal disorders.
Patients with coagulation problems.
Patients who have an underlying chronic disease and have to take special drugs.
Patients whose HIV, HCV or HBV test results are positive.
Patients who have a history of asthma and allergy to certain drugs.
Patients with intrauterine anomalies.
Age
From 18 years old to 41 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation will be with the help of a table of random numbers, and patients will be placed in one of two study groups based on the order of entry into the study and the results of random number calculations.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the person who analyzed the results were blinded in this study. Participants were aware of the study before being randomized and informed consent was obtained from them. It should be noted that the person analyzing the results had no other role in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
6446-14155
Approval date
2023-01-23, 1401/11/03
Ethics committee reference number
IR.TBZMED.REC.1401.945
Health conditions studied
1
Description of health condition studied
Recurrent implantation failure
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Pregnancy rate
Timepoint
After positive beta-hCG test, clinical pregnancy was evaluated at 5-6 week
Method of measurement
Examining the formation of gestational sac using Sonography method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: According to the protocol, 1 to 2 mg of tacrolimus drug is administered orally to the study subjects daily, taking into account the level of immune system activity of the patients 2 days before the transfer and 14 days after the transfer.
Category
Treatment - Drugs
2
Description
Control group: receive no intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center at Alzahra Hospital
Full name of responsible person
Dr. Mehdi Yousefi
Street address
South Artesh Street, Alzahra Medical Education Center
City
Tabriz
Province
East Azarbaijan
Postal code
6446-14155
Phone
+98 41 3327 3000
Email
mehdi_yusefi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
mehdi_yusefi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5414846649
Phone
+98 41 3336 4665
Email
amir.valizadeh67@gmail.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