This study designed to identify the immunological causes of recurrent miscarriage and using IVIG for treatment of these patients.In this study patients with recurrent spontaneous abortion in terms of immunological problems investigated and 40 patients with cellular immunity abnormalities will selected. The patients ranging from 20 to 41 years and IVIG will be used at a dose of 400 mg per kilogram of body weight to treat patients. Patients will be selected from September 95 to June 96 in Al-Zahra Infertility Center Hospital in Tabriz and as soon as the pregnancy will receive a dose of IVIG therapy and then every 4 weeks during pregnancy will receive IVIG treatment. At the end of 32 weeks the last dose of the IVIG will be injected into the patient.The main inclusion criteria included at least three times abortion and cellular immune system problems.Exclusion criteria include anatomical, genetic and chromosomal abnormalities and immunotherapy history. At the end of treatment, the pregnancy success rate and changes to the immune system will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050127520N2
Registration date:2016-09-02, 1395/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-02, 1395/06/12
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
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of IVIg on Pregnancy Rate of Patient with recurrent pregnancy loss with Immunological Causes
Public title
IVIG and treatment of recurrent spontaneous abortion (RSA)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who experienced at least three miscarriage; 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
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- daneshghah st- tabriz university of medical sciences
City
Tabriz
Postal code
7386-51656
Approval date
2016-07-04, 1395/04/14
Ethics committee reference number
IR.TBZMED.REC.1395.316
Health conditions studied
1
Description of health condition studied
Recurrent aburtion
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion
Primary outcomes
1
Description
Pregnancy rate
Timepoint
After treatment
Method of measurement
Live birth
Secondary outcomes
1
Description
Immune cells modification
Timepoint
After treatment
Method of measurement
Flow cytometry, ELISA, RT-PCR
Intervention groups
1
Description
IVIG 400 mg per kg of body weight once every four weeks until week 32 of pregnancy
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
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medica; 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 medica; 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
Department of Immunology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Mehdi Yousefi
Position
Professor Assistant
Other areas of specialty/work
Street address
Department of Immunology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Postal code
51656-87386
Phone
+98 41 1336 4665
Fax
Email
mehdi_yousefy@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 41 1336 4665
Fax
Email
yousefime@tbzmed.ac.ir
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 41 3336 4665
Fax
Email
m.ahmadi6892@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)