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IRCT20191231045960N1 IRCT 2020-01-19 Mashhad University of Medical Sciences Investigation of immunomodulatory effects of hydroxychloroquine on pregnancy outcomes in patients with repeated implantation failure Investigation of immunomodulatory effects of hydroxychloroquine on pregnancy outcomes in patients with repeated implantation failure (RIF) 2019-09-23 anticipated 70 Complete https://irct.ir/trial/44663 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 women infertility. Intervention 1: 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). Intervention 2: 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 . Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Elahe Akhgari
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2608 akhgarie971@mums.ac.ir Mashhad University of Medical Sciences scientific Malihe Afiat
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2608 afiatm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 20 years 42 years Female Drug sensitivity patient dissatisfaction N98.3 Complications of attempted introduction of embryo in embryo transfer Treatment - Drugs N/A 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). 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 . Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: Conducting BHCG test. Implantation rate. Timepoint: 2-4 weeks after BHCG test is positive. Method of measurement: viewing the number of gestational sacs using ultrasound scan. Clinical pregnancy. Timepoint: 3-5 weeks after BHCG test is positive. Method of measurement: viewing the live fetus using ultrasound scan. Mashhad University of Medical Sciences Approved 2019-08-27 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)