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IRCT20250507065634N3 IRCT 2025-08-24 Mashhad University of Medical Sciences Comparing the effect of immunotherapy with hydroxychloroquine and vitamin D3 Comparative study of the effect of immunotherapy with hydroxychloroquine and vitamin D3 compared to vitamin D3 alone in patients with recurrent miscarriage 2025-09-17 anticipated 80 Complete https://irct.ir/trial/85554 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Experimental and control groups: After selecting the sample, in the next step, people are divided into experimental and control groups using a random method. How to perform randomization: First step: After selecting the voluntary sample, all selected people are placed on a list (numbers from one to 80 are assigned to people). Second step: From these individuals, a random method is used to divide them into two experimental groups and a control group, using sealed and opaque (numbered) envelopes. Each person randomly selects an envelope and is divided into the corresponding group, Blinding description: The study was double-blind. Participants were assigned to groups using sealed, opaque envelopes containing an allocation code (A and B). These envelopes were opened as individuals arrived, and each participant's unique code was recorded. The main study coordinator was responsible for maintaining the allocation list and did not interfere with the assessment or care process. Participants and caregivers were unaware of their assigned group. Information about the type of possible intervention, medications, and possible drug side effects was explained to participants, and consent was obtained from participants. The outcome assessors also only saw the participant identification code and did not have access to information about the groups. The intervention and control packages were identical in appearance and packaging to prevent their identification. 2-3 Condition 1: Recurrent Pregnancy Loss. Condition 2: Spontaneous abortion. Intervention 1: Control group: They will receive oral vitamin D3 1000 units daily after a positive pregnancy test and confirmation of intrauterine pregnancy with serial pregnancy tests or vaginal ultrasound until the 20th week of pregnancy. Ultrasound will be performed at 6-8, 11-13, and 18-22 weeks of pregnancy. Intervention 2: Intervention group: Receive oral hydroxychloroquine 200 mg twice daily every 12 hours along with oral vitamin D3 1000 units daily after a positive pregnancy test and confirmation of intrauterine pregnancy with serial titration of pregnancy test or vaginal ultrasound until the 20th week of pregnancy. Ultrasound will be performed at 6-8 weeks, 11-13 weeks, and 18-22 weeks of pregnancy. Yes - There is a plan to make this available What will be shared: Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals. When: Data can be made available 4 months after the results are published and after personally identifiable information is removed. To whom: The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions. Conditions: Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential. Where to obtain: If you need data, please contact jahantigh.sh71@gmail.com How to obtain: After receiving and reviewing the request from the researcher, the request will be responded to as soon as possible. Comments:
public Shaghayegh Jahantigh
Unit 405, Soroush Building, Elaheieh 16, Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) ۹۱۸۶۳۴۳۷۵۹ +98 936 600 3045 jahantigh.sh71@gmail.com Mashhad University of Medical Sciences scientific Malihe Afiat
Between Khaqani 5 and 7, Khaqani Boulevard, Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) 9177740015 +98 915 505 6897 Afiatm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women between the ages of 18 and 40 Women who are trying to conceive Women with a history of at least two consecutive first-trimester miscarriages of unknown origin, with normal parental karyotype, absence of uterine abnormalities associated with recurrent miscarriage Normal serum vitamin D levels (above 30) and less than 100 Consent to participate in the study 18 years 40 years Female Pregnancy at the time of study entry Normal pregnancy since last miscarriage Antiphospholipid syndrome with persistently positive APL antibodies and the presence of clinical conditions of APS based on Myakis criteria Known contraindications for the use of hydroxychloroquine or vitamin D Other chronic diseases History of epilepsy or psychotic disorders History of recent use of hydroxychloroquine or vitamin D in the past two months O26.2 O03 Pregnancy care for patient with recurrent pregnancy loss Spontaneous abortion Placebo Diagnosis Control group: They will receive oral vitamin D3 1000 units daily after a positive pregnancy test and confirmation of intrauterine pregnancy with serial pregnancy tests or vaginal ultrasound until the 20th week of pregnancy. Ultrasound will be performed at 6-8, 11-13, and 18-22 weeks of pregnancy. Intervention group: Receive oral hydroxychloroquine 200 mg twice daily every 12 hours along with oral vitamin D3 1000 units daily after a positive pregnancy test and confirmation of intrauterine pregnancy with serial titration of pregnancy test or vaginal ultrasound until the 20th week of pregnancy. Ultrasound will be performed at 6-8 weeks, 11-13 weeks, and 18-22 weeks of pregnancy. Frequency of ongoing pregnancy. Timepoint: Week 20 onwards. Method of measurement: Ultrasound. Repeated miscarriage. Timepoint: Before week 20. Method of measurement: Fetal loss before 20 weeks with Ultrasound. Gestational age at the time of miscarriage. Timepoint: Number of weeks of pregnancy. Method of measurement: Ultrasound. Fetal abnormalities. Timepoint: Weeks 6-8, 11-13, 18-22 of pregnancy. Method of measurement: Ultrasound. Mashhad University of Medical Sciences Approved 2025-08-04 Research Ethics Committees of Imam Reza Hospital Educational, Research and Treatment Center- Mashhad Basement Floor (-1), Educational Complex Building, Imam Reza Hospital, Mashhad, Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)