1. Home
  2. Approved trials
  3. » فارسی

Comparing the Effectiveness of Tacrolimus and the lack of Drug Treatment in Pregnancy Rate of Patients with Recurrent Implantation Failure

Protocol summary

Study aim
pregnancy Rate in women with Recurrent Implantation Failure treated with Tacrolimus
Design
A randomized, nonblinded, controlled clinical trial with a Factorial group design of 162 patients. Randomization using Stratified Blocked Randomization Method will be done. The Random Sequence will be generated by the Software of the Website Sealed Envelope.com.
Settings and conduct
Frozen Embryo Transfer in Avicenna Infertility Clinic, will be included in the study. Patients Referred to this Center who are Eligible for the study are Divided into Two groups of Treatment with Tacrolimus and the group without Treatment based on random blocks. Endometrial Preparation Cycle with Estrogen and Progesterone will be similar in both groups. The Results obtained in these two groups are compared.
Participants/Inclusion and exclusion criteria
patients aged 20 to 39 years with Unexplained RIF with a history of Three or more Unsuccessful Embryo Transfers are included in the study. Patients who used Immunosuppressive Drugs, Chronic Endometritis, Uterine Anomalies, Active Viral, Fungal and Bacterial Diseases, Patients with Hypertension, Renal failure, liver Disorders, Heart Failure, Ischemic Heart Disease or Arrhythmia ,Patients with Immunodeficiency, Malignancy, organ Transplantation, Sensitivity to Tacrolimus, Blood Disorders, Endocrine Disorders, Antiphospholipid Syndrome and Vascular Collagen Disease , Patients Receiving potassium-sparing Diuretics ,Patients who Received live vaccine 2 months before admission are excluded from the study .
Intervention groups
Patients Receiving Tacrolimus Two Days before Embryo Transfer for 16 days , dose of 0.5 mg , twice a day.
Main outcome variables
Chemical, Clinical , Ongoing Pregnancy Rate and Abortion Rate

General information

Reason for update
Acronym
RIF
IRCT registration information
IRCT registration number: IRCT20240429061583N1
Registration date: 2024-05-10, 1403/02/21
Registration timing: registered_while_recruiting

Last update: 2024-05-10, 1403/02/21
Update count: 0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Nahal Nasehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 7347
Email address
nasehi-n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-30, 1403/02/11
Expected recruitment end date
2024-10-02, 1403/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Tacrolimus and the lack of Drug Treatment in Pregnancy Rate of Patients with Recurrent Implantation Failure
Public title
Effect of Tacrolimus in treatment of Recurrent Implantation Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unexplained RIF History of Three or more Failed Embryo Transfers
Exclusion criteria:
Patients who Used Immunosuppressive Drugs Chronic Endometritis Uterine Anomaly Active Viral Diseases, Tuberculosis, Invasive Fungal Infections and Bacterial Infections Patients with High Blood Pressure, Renal Failure, liver Disorder, Heart Failure, Ischemic Heart Disease , Arrhythmia, Untreated Endocrine Disorder Immunocompromised Patients Patients with Malignant Tumors Patients with a history of Organ Transplantation Patients with a history of Tacrolimus Allergy Patients with a history of Blood Disorders, Coagulopathy Antiphospholipid Syndrome and Collagen Vascular Disease Patients receiving Potassium-Sparing Diuretics Patients who received Live Vaccine 2 months before admission
Age
From 20 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 162
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Blocked Randomization
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
Ethical Committee of the Institute of New Technologies of Biological Sciences, Academic Jihad - AVIC
Street address
No. 97, Yakhchal St, Dr. Shariati Ave, Avicenna Clinicc
City
Tehran
Province
Tehran
Postal code
1941913114
Approval date
2024-04-23, 1403/02/04
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1403.002

Health conditions studied

1

Description of health condition studied
Recurrent Implantation Failure
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Chemical pregnancy Rate
Timepoint
Day 14 and 16 after embryo transfer
Method of measurement
level of serum βHCG

2

Description
Clinical Pregnancy Rate
Timepoint
4 to 5 Weeks after Embryo Transfer
Method of measurement
ultrasound and Observe at least one Gestational Sac

Secondary outcomes

1

Description
Ongoing Pregnancy Rate
Timepoint
12 Weeks after Embryo Transfer
Method of measurement
Normal Pregnancy with Fetal Heartbeat in ultrasound

2

Description
Abortion Rate
Timepoint
12 Weeks after Embryo Transfer
Method of measurement
Excretion of Pregnancy Products or Failure to see Fetal Heart in Ultrasound at the end of 12 Weeks

Intervention groups

1

Description
Intervention group: Tacrolimus is taken at a dose of 0.5 mg twice a day, starting two days before the Embryo Transfer, for 16 days.
Category
Treatment - Drugs

2

Description
Control group: without medicine
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Avicenna Clinic
Full name of responsible person
Nahal Nasehi
Street address
No. 97, Yakhchal St, Dr. Shariati Ave, Avicenna Clinicc
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
nasehi-n@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Dr.Soheila Arefi
Street address
No. 97, Yakhchal St, Dr. Shariati Ave, Avicenna Clinicc
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
nasehi-n@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Iranian academic center for education culture and research
Full name of responsible person
Soheila Arefi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 97, Yakhchal Ave., Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
nasehi-n@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Soheila Arefi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 97, Yakhchal Ave., Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
nasehi-n@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Nahal Nasehi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No97, Avicenna Infertility Treatment Center ,Yakhchal Street, Shariaty Ave ty
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 61 3333 7347
Fax
Email
nasehi-n@ajums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All project documents are available in the research institute and will be available to interested parties in the form of articles and final reports.
When the data will become available and for how long
The start of access can be at the same time as printing the results.
To whom data/document is available
All researchers in academic and scientific institutions can apply for them
Under which criteria data/document could be used
It is possible to request data for all researchers who work in related fields.
From where data/document is obtainable
The e-mail address and postal address of the project implementers will be provided to the applicants.
What processes are involved for a request to access data/document
Applicants can send their application through the e-mail address of the administrators of the project.
Comments
Loading...