Prednisone for patients with recurrent implantation failure: study protocol for a double-blind, multicenter, randomized, placebo-controlled trial

Nowadays, infertility affects 8-12% of couples at reproductive age and has become a global problem [1]. In vitro fertilization (IVF) is widely used and well received in couples with reproductive difficulties. However, despite the optimal use of reproductive technologies (such as controlled ovarian hyper-stimulation, assisted hatching, pre-implantation genetic testing, and frozen embryo transfer), implantation remains a rate-limiting step in IVF treatment. Implantation rate is reported to be about 25% when cleavage embryos are transferred and 40% when blastocysts are transferred, which indicates that many couples would remain infertile after multiple attempts at embryo transfer [2].

Recurrent implantation failure (RIF) refers to the clinical condition of failing to achieve a clinical pregnancy after several embryo transfers, which brings great challenges to clinicians and causes deep frustration to patients [3]. The prevalence of RIF varies from 10 to 20% and is difficult to estimate, due to the condition that there is yet no universally accepted consensus on the definition of RIF [2, 4, 5]. Failure of implantation can be attributed to embryo quality, endometrial receptivity, or both. While poor embryo quality is thought to be responsible for 30-50% of implantation failures, decreased endometrial receptivity is responsible for approximately two thirds of these failures [6, 7]. Thus, many interventions aiming at overcoming decreased endometrial receptivity have been proposed to improve pregnancy outcomes in women with RIF, but only a few are evidence-based [8, 9].

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Prednisone is a common immunomodulatory agent, which can exert a range of positive effects on the treatment of autoimmune disorders as well as the establishment of early pregnancy [1, 10]. Studies have shown that prednisone could not only suppress uterine NK cells cytotoxicity and cytokine secretion in pre-implantation endometrium, but also stimulate the secretion of human chorionic gonadotropin (hCG) and promote proliferation and invasion of trophoblast [1, 6], suggesting that prednisone may have a considerable impact on embryo implantation and IVF outcomes. Prednisone is also believed to have minimal side effects [11], because only about 10% of the active substance will reach the fetus [12,13,14].

However, limited clinical trials have focused on the effect of prednisone on pregnancy outcomes. Also, the trials were either small-sized or non-randomized studies or with combined treatment regimens, which were insufficiently powered to draw a conclusion. Therefore, multiple researchers and clinicians have called for a full-scale and well-designed randomized controlled trial (RCT) to clarify whether prednisone could improve pregnancy outcomes in women with RIF [15].

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