Investigation of immunomodulatory effects of hydroxychloroquine on pregnancy outcomes in patients with RIF
Design
Clinical trial with control group (sample size of 70), parallel groups, triple blind, randomized
Settings and conduct
This is a triple blind study (patient, researcher and data analyst are blinded) and includes patients referring to Milad Infertility Clinic in Mashhad who are randomly assigned to two groups through simple randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant woman with lower than 35 years old and 3 unsuccessful IVF in embryo transfer, pregnant woman with greater than 35 years old and 2 unsuccessful IVF in embryo transfer, women with uterine cavity and normal thrombophilia tests and with good-quality embryos
Exclusion criteria: drug sensitivity, patient dissatisfaction
Intervention groups
Control group: Patients receive 4 mg of Estradiol valerate in the first 7 days of cycle for preparation of endometrium and 6 mg of it in the next 7 days until the endometrium is prepared. Following endometrial preparation based on a good quality fetal age (3 or 5 days), 800-mg Progesterone is given to patients .
Intervention group: In addition to the routine treatment of the control group, each person is given 2 tablets of 200-mg hydroxychlorine per day from the third day of the menstrual cycle up to 14 days after embryo transfer (time of pregnancy test).
Main outcome variables
Chemical pregnancy (conducting the BHCG test 14 days after embryo transfer); implantation rate; clinical pregnancy (viewing live fetus using ultrasound scan)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191231045960N1
Registration date:2020-01-19, 1398/10/29
Registration timing:registered_while_recruiting
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Elahe Akhgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2477
Email address
akhgarie971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of immunomodulatory effects of hydroxychloroquine on pregnancy outcomes in patients with repeated implantation failure (RIF)
Public title
Investigation of immunomodulatory effects of hydroxychloroquine on pregnancy outcomes in patients with repeated implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant woman with lower than 35 years old and 3 unsuccessful IVF in embryo transfer
pregnant woman with greater than 35 years old and 2 unsuccessful IVF in embryo transfer
women with uterine cavity and normal thrombophilia tests and with good-quality embryos
Exclusion criteria:
Drug sensitivity
patient dissatisfaction
Age
From 20 years old to 42 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one patient and places her in one of the two groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, participants are not aware of the type of treatment and the intervention. The researcher is also unaware of the type of drug being administered, and the analyst does not know which codes belong to which groups. Only a non-beneficiary outside the project is aware of the codes that will be decrypted after the completion the statistical analyses.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.702
Health conditions studied
1
Description of health condition studied
women infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Conducting BHCG test
2
Description
implantation rate
Timepoint
2-4 weeks after BHCG test is positive
Method of measurement
viewing the number of gestational sacs using ultrasound scan
3
Description
clinical pregnancy
Timepoint
3-5 weeks after BHCG test is positive
Method of measurement
viewing the live fetus using ultrasound scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive 4 mg of Estradiol valerate in the first 7 days of cycle for preparation of endometrium and 6 mg of it in the next 7 days until the endometrium is prepared. Following endometrial preparation based on a good quality fetal age (3 or 5 days) 800-mg Progesterone is given to patients . In addition to routine treatment, each person is given 2 tablets of 200-mg hydroxychlorine per day from the third day of the menstrual cycle up to 14 days after embryo transfer (time of pregnancy test).
Category
Treatment - Drugs
2
Description
Control group: Intervention group: Patients receive 4 mg of Estradiol valerate in the first 7 days of cycle for preparation of endometrium and 6 mg of it in the next 7 days until the endometrium is prepared. Following endometrial preparation based on a good quality fetal age (3 or 5 days) 800-mg Progesterone is given to patients .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Fertility Clinic
Full name of responsible person
Malihe Afiat
Street address
Milad Fertility Clinic, beside Sina hospital, Akhond Khorasani 32 Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
afiatm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?