Effect of routine treatment with and without intravenous immunoglobulin (IVIG) on Th17 and Th1:Th2 and CD56+16+ serum levels in patients with repeated unexplained in vitro fertilization failure: a randomized clinical trial
To assess the effect of routine treatment with and without intravenous immunoglobulin (IVIG) on Th17 and Th1:Th2 and CD56+16+ serum levels in patients with repeated unexplained in vitro fertilization failure
Design
This a randomized clinical trial, phase II, in which 42 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients repeated unexplained in vitro fertilization failure who will refer to Fetemieh Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 20 to 35 years
Repeated unexplained in vitro fertilization failure
Exclusion criteria:
Anatomical abnormalities of the uterus
Endocrine disorder
Genetic disorder
Infectious diseases
Intervention groups
Intervention group: Routine treatment plus intravenous immunoglobulin single dose before embryo transfer
Control group: Just routine treatment
Main outcome variables
Primary outcome:
Measuring Th17 before intervention and two weeks after that through laboratory test
Measuring Th1:Th2 before intervention and two weeks after that through laboratory test
Measuring CD56+16+ before intervention and two weeks after that through laboratory test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N217
Registration date:2018-04-21, 1397/02/01
Registration timing:retrospective
Last update:2018-04-21, 1397/02/01
Update count:0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of routine treatment with and without intravenous immunoglobulin (IVIG) on Th17 and Th1:Th2 and CD56+16+ serum levels in patients with repeated unexplained in vitro fertilization failure: a randomized clinical trial
Public title
Effect of routine treatment with and without intravenous immunoglobulin (IVIG) on fertility induction in patients with repeated unexplained in vitro fertilization failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 35 years
Repeated unexplained in vitro fertilization failure
Exclusion criteria:
Anatomical abnormalities of the uterus
Endocrine disorder
Genetic disorder
Infectious diseases
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to the intervention and control groups by random sequencing method, in which 21 patients will be assigned to the intervention group and 21 patients will be assigned to the control group.
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
IR.UMSHA.REC.1395.580
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Measuring Th17
Timepoint
Before intervention and two weeks after that
Method of measurement
Through laboratory test
2
Description
Measuring Th1:Th2
Timepoint
Before intervention and two weeks after that
Method of measurement
Through laboratory test
3
Description
Measuring CD56+16+
Timepoint
Before intervention and two weeks after that
Method of measurement
Through laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus intravenous immunoglobulin prepared from fresh plasma 400 mg/kg just single dose before embryo transfer
Category
Treatment - Drugs
2
Description
Control group: Just routine treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr Tayebeh Artimani
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
artimani@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Artimani
Position
Reproduction Biology Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
artimani@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Artimani
Position
Reproduction Biology Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
artimani@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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