Comparative study of the effect of immunotherapy with hydroxychloroquine and vitamin D3 compared to vitamin D3 alone in patients with recurrent miscarriage

Comparison of the results of using a combination of hydroxychloroquine and vitamin D3 compared to vitamin D alone on live birth in women with a history of recurrent miscarriage

The clinical trial will be conducted in a controlled, double-blind, randomized, phase 2 and 3, parallel-group design on 80 eligible subjects. The sealed envelope method will be used for randomization.

Eligible women aged 18–40 years at Imam Reza and Ghaem hospitals in Mashhad will be divided into two groups after randomization: Intervention group: 200 mg of hydroxychloroquine every 12 hours + 1000 units of vitamin D3 daily from 6 to 20 weeks of pregnancy. Control group: Routinely receive 1000 units of vitamin D3 daily. Examinations will be performed by ultrasound. The study is double-blind, and the assessors and analysts are unaware of the groups.

Inclusion criteria: Women aged 18 to 40 years, trying to conceive, with at least 2 consecutive first-trimester miscarriages of unknown origin, a normal parental karyotype, no uterine abnormalities, serum vitamin D level 30 to 100, and consent to participate in the study. Exclusion criteria: Pregnancy at entry or normal pregnancy after the last miscarriage, antiphospholipid syndrome (persistent positive APL + Myakis criteria), contraindications for hydroxychloroquine or vitamin D, other chronic diseases, history of epilepsy or psychotic disorders, recent use of hydroxychloroquine or vitamin D in the past two months.

Control group: A group of 40 people is eligible for inclusion and receives 1000 units of oral vitamin D3 daily. Intervention group: A group of 40 people is eligible for inclusion and receives 200 mg of oral hydroxychloroquine twice daily, every 12 hours, along with 1,000 units of oral vitamin D3 daily.

Frequency of ongoing pregnancy

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.

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.

Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.

Data can be made available 4 months after the results are published and after personally identifiable information is removed.

The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.

Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.

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