The effect of hydroxychloroquine on pregnancy outcomes in patients with unexplained recurrent pregnancy loss: a placebo-controlled study "pilot study".

This double-blind placebo-controlled study investigated the effect of hydroxychloroquine on pregnancy outcomes in people with unexplained recurrent pregnancy loss (URPL). The inclusion criteria included gestational age ≤6 weeks and a history of at least two miscarriages. The exclusion criteria included any known cause for previous abortions or a history of any chronic diseases. Participants were given 200 mg hydroxychloroquine or placebo twice a day until gestational week 20. Twenty-nine women were enrolled. There was no statistically significant difference between the two groups in terms of age, BMI, gravidity, previous abortion, relative married couple, and infertility. Miscarriage occurred in five women including one in the hydroxychloroquine group (7.69%) and four women in the placebo group (28.57%) (OR: 2.36, 95% PL CI:1.07, 8.93). However, after adjusting for potential confounders, there was no significant difference between the two groups (aOR: 2.96, 95%CI: 0.91, 10.02).IMPACT STATEMENT Miscarriage, a prevalent concern in the field reproductive medicine, causes psychological and family problems for couples. Unfortunately, no effective treatment has been yet found for URPL. There are some hypotheses about the role of immunological factors in URPL. Hydroxychloroquine (HCQ) has various immunological effects and may theoretically have a role in the treatment of URPL. Although few studies have been registered to investigate the effect of HCQ on URPL, none of them has been published. In our double-blind placebo-controlled trial, the prevalence of abortion in the HCQ group was four times lower than that in the placebo group, however, this difference was not statistically significant, which can be attributed to the small sample size. We hope that HCQ will be of interest to researchers and future research help clarify the role of HCQ in preventing URPL.