Over the decades assisted reproductive technologies and in vitro fertilization (IVF) help infertile couples to conceive, however the implantation rate is one of the limiting factors in assisted reproductive techniques. The aim of our study is to select patients with repeated implantation failure (RIF) on the basis of immunological disorders and their treatment with IVIG. The study included 40 patients with repeated implantation failure ranging from 18 to 41 years and IVIG at a dose of 400 mg per kilogram of body weight will be used to treat patients. RIF patients will be selected from September 95 to June 96 in Alzahra Hospital Fertility Center and one or two days before the embryo transfer will receive one dose IVIG. Inclusion criteria included the failure of IVF at least 3 times and immunological disorders. Exclusion criteria included genetic and chromosomal disorders and Immunotherapy history. Finally, after embryo transfer IVF success rates will evaluate by βHCG and ultrasound.Moreover, patients immunological parameters will be evaluated before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080527520N3
Registration date:2016-08-24, 1395/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-24, 1395/06/03
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
Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of IVIg on Pregnancy Rate of Paitent with Recurent Implantation Failure with Immunological Causes
Public title
IVIG and treatment of recurrent implantation failure (RIF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who experienced at least two implantation failure; patients with Azeri origin; Patients who did not have any type of immunotherapy in his medical history.
Exclusion criteria: Patients below 18 years and above 41 years; Patients with abnormal karyotype or chromosomal disorders; patients who have bleeding problems; Patients who have chronic disorders such as diabetes; Patients who have HIV, HCV or HBV positive tests; Patients who have a history of asthma and allergies to certain drugs; patients who have uterus anomalies.
Age
From 18 years old to 41 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Drug Applied Research Center
Street address
Tabriz University of Medical Sciencesabriz, Daneshghah st, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2016-07-04, 1395/04/14
Ethics committee reference number
IR.TBZMED.REC.1395.315
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
Embryo Implantation
Timepoint
2 month after intervention
Method of measurement
Laboratory tests and ultrasound
Secondary outcomes
1
Description
Changes in immune cells
Timepoint
2 month after intervention
Method of measurement
Flow cytometry, ELISA, RT-PCR
Intervention groups
1
Description
1 or 2 days before embryo transfer 400 mg per kilogram of IVIG will be administered intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Majidi infertility center of Tabriz Alzahra Hospital
Full name of responsible person
Mehdi Yousefi
Street address
Department of Immunology, Tabriz University of Medical Scaences, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Seciences
City
Tabriz
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Medical Immunology
Other areas of specialty/work
Street address
Department of Immunology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 413364665
Fax
Email
mehdi_yusefi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mehdi Yousefi
Position
PhD of Immunology
Other areas of specialty/work
Street address
Department of Immunology, Tabriz University of Medical Sciences,
City
Tabriz
Postal code
Phone
+98 413364665
Fax
Email
mehdi_yusefi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Scaences
Full name of responsible person
Majid Ahmadi
Position
PhD of Immunology
Other areas of specialty/work
Street address
Department of Immunology, Faculty of Medicine, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 413364665
Fax
Email
m.ahmadi6892@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)