Immunomodulatory Effects of Hydroxychloroquine on immunological factors involved in implantation of women with repeated implantation failure: clinical trial
This study was designed to evaluate the effectiveness of Hydroxychloroquine on implantation. This clinical trial is performed in Infertility and IVF word, Shahid Motahari hospital. 30 infertile patients with a history of at least three repeated implantation failure or immune system disorders (impaired T helper 1/ T helper 2 balance) are recruited into the study. Patients were treated with 400 mg Hydroxychloroquine daily for 16 days. The treatment was started from day 3 or 4 of the menstrual cycle and at the 19-20th day of the cycle, the endometrial samples were obtained. In fact, the sampling was performed twice: once before the treatment and again after the treatment. Then, each endometrial sample was divided into two parts to examine the cytokines involved in the implantation by immunohistochemistry and their related genes by polymerase chain reaction (PCR).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060634209N1
Registration date:2017-07-13, 1396/04/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-13, 1396/04/22
Registrant information
Name
Hojjat Ghasemnejad berenji
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 340 7313
Email address
ghasemnejad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immunomodulatory Effects of Hydroxychloroquine on immunological factors involved in implantation of women with repeated implantation failure: clinical trial
Public title
Effect of Hydroxychloroquine in patients with repeated implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients having an immunological disorder in serum (Tumor necrosis factor alpha/Interleukin-10>= 30.6); 3 failed embryo transfer
Exclusion criteria: uterine abnormality (acquired or congenital); unwillingness to continue
Age
From 25 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Postal code
Approval date
2017-05-30, 1396/03/09
Ethics committee reference number
IR.SBMU. MSP.REC.1396.160
Health conditions studied
1
Description of health condition studied
Repeated Implantation Failure
ICD-10 code
N-97.2
ICD-10 code description
Female infertility of uterine origin
Primary outcomes
1
Description
Interleukin -10
Timepoint
Twice: before and after intervention
Method of measurement
Immunohistochemistry
2
Description
Tumor necrosis factor alfa
Timepoint
Twice: before and after intervention
Method of measurement
Immunohistochemistry
3
Description
Interleukin-17
Timepoint
Twice: before and after intervention
Method of measurement
Immunohistochemistry
4
Description
GATA3 gene
Timepoint
Twice: before and after intervention
Method of measurement
Polymerase chain reaction
5
Description
Interleukin-4
Timepoint
Twice: before and after intervention
Method of measurement
Immunohistochemistry
6
Description
T-bet gene
Timepoint
Twice: before and after intervention
Method of measurement
Polymerase chain reaction
7
Description
FOXP-3 gene
Timepoint
Twice: before and after intervention
Method of measurement
Polymerase chain reaction
8
Description
RORγt gene
Timepoint
Twice: before and after intervention
Method of measurement
Polymerase chain reaction
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer in next cycle
Method of measurement
Serum BHCG
Intervention groups
1
Description
Women receive oral Hydroxychloroquine (400 mg/day) for 16 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and IVF ward of Shahid Motahari hospital
Full name of responsible person
00984433197713
Street address
Kashani Blvd Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Urmia University of Medical Sciences
Full name of responsible person
Dr.Sonia Sadeghpour
Position
Assistant professor
Other areas of specialty/work
Street address
Shahid Motahari Hospital, Kashani Blvd
City
Urmia
Postal code
Phone
+98 44 3319 7713
Fax
Email
dr.sadeghpour.s@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Marefat Ghaffari Novin
Position
Professor
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences, Yaman st, Velenjak, Chamran highway
City
Tehran
Postal code
Phone
+98 21 2387 2555
Fax
Email
ghasemnejad@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Hojjat Ghasemnejad Berenji
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)