If the effect of lymphocyte therapy in the treatment of women suffering from miscarriage is determined, this treatment can be used together with other treatments or alone to solve the problem of women suffering from repeated spontaneous abortions with unknown reasons in South Khorasan province
Design
Phase 1 on 50 patients, non-randomly
Settings and conduct
Women suffering from repeated spontaneous abortions in the age range of 20-45 years, referred to Roish Birjand infertility clinic with the possibility of immunological reasons.
1) To perform lymphocyte therapy, fresh blood with heparin anticoagulant (50-80 ml) will be taken from the spouses of all participants.
2) Peripheral blood polymorphonuclear cells (PBMC) will be isolated using Ficoll.
3) The obtained cells will be washed three times with physiological serum and will be placed in a volume of 1 ml of physiological serum.
4) The amount of 80 to 100 million cells will be injected intradermally in three places in the forearm. Immunization will be done at intervals of 3 weeks and up to 3 times.
5) 3 weeks after the last immunization, necessary tests will be performed to check the existence of Anti Paternal Anti Cytotoxic Antibody (APCA) by CDC complement-dependent cytotoxicity method to confirm the production of blocking antibody.
6) Immunization will be done once every three months during pregnancy.
Participants/Inclusion and exclusion criteria
Presence of repeated miscarriages with unknown reasons and the possibility of immunological reasons
Presence of APCA antibody percentage lower than 5%
Exit criteria
Presence of abortion with known non-immunological reasons
Presence of APCA antibody percentage higher than 5%
Intervention groups
Women with frequent spontaneous abortions
Main outcome variables
Lymphocyte therapy ,APCA antibody percentage ,No miscarriage and successful pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201126049497N2
Registration date:2024-07-11, 1403/04/21
Registration timing:prospective
Last update:2024-07-11, 1403/04/21
Update count:0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Vajihe Hazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 6691
Email address
vajihehazari@bums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of lymphocyte therapy effects on treatment of women with unexplained Recurrent Spontaneous Abortion (RSA)
Public title
Evaluation of lymphocyte therapy effects on treatment of women with unexplained Recurrent Spontaneous Abortion (RSA)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range from 18 to 35 years
The presence of repeated miscarriages with unknown reasons and the possibility of immunological reasons
Presence of APCA antibody percentage lower than 5%
Exclusion criteria:
Presence of abortion with known non-immunological causes
Presence of APCA antibody percentage higher than 5%
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
IR.BUMS.REC
Street address
Ghaffari Street, Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2024-05-21, 1403/03/01
Ethics committee reference number
1403.084
Health conditions studied
1
Description of health condition studied
Recurrent spontaneous abortion
ICD-10 code
(O31.1)
ICD-10 code description
Primary outcomes
1
Description
No abortion and successful pregnancy
Timepoint
Before the intervention and after the intervention
Method of measurement
The number of births resulting in the birth of a healthy baby
Secondary outcomes
1
Description
APCA antibody percentage
Timepoint
At intervals of 3 weeks and up to 3 times
Method of measurement
complement-dependent cytotoxicity method
Intervention groups
1
Description
Intervention group: Miscarriage patients
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roish Infertility Center
Full name of responsible person
Vajihe Hazari
Street address
The beginning of Beheshti St, Birjand city
City
Birjand
Province
South Khorasan
Postal code
9719873839
Phone
+98 56 3229 0644
Email
vajihehazari@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mr. Dr. Yousefi
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
karimisomaye72@gmail.com
Grant name
60000000 million tomans
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Vajihe Hazari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tawheed St
City
Birjand
Province
South Khorasan
Postal code
9719873839
Phone
+98 56 3243 6691
Email
dr.vhazari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mitra Rafiee
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
rafiee64mitra@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Somaye Karimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Immunology
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
9773154970
Phone
+98 56 3274 4271
Email
karimisomaye72@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD