P-577 A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: An RCT

Abstract

Abstract Study question To evaluate a combined therapeutic protocol of lipid emulsion, prednisolone & LMWH in cases of failed ART cycles with high NK cells Summary answer The combined therapy of lipid emulsion, prednisolone & LMWH had a higher pregnancy rate but not significant than the standard therapy alone. What is known already Many researchers have proved that a high numbers and/or cytotoxicity of peripheral blood NK cells is associated with infertility, recurrent spontaneous miscarriage (RSM) and failed ART cycles. Many investigations have shown that intralipid has the ability to suppress NK cell activity. It is well known that parenteral fat emulsions accumulate in macrophages modifying many immune responses. So, modifying the T helper1/ T helper 2 balance in favor of T helper 2 with implantation chances increase. Prednisolone has an immunosuppressive and anti-inflammatory actions and has widely used in autoimmune diseases. Prednisolone also reduces the high numbers of uNK in RSM. Study design, size, duration This was a prospective randomized controlled trial in 100 cases with failed ART cycles & high NK cells. From Jan 2019- Dec 2021 Participants/materials, setting, methods One hundred failed ART cases with high NK cells were divided into 2 groups: (Control group)(50 cases) with previous failed ART cycles will undergo standard treatment (progesterone, low dose aspirin & folic a.). While the other (Interventional group)(50 cases) will have in addition to the previous protocol: lipid emulsion begin in the cycle before embryo transfer & prednisolone begin with the start of lipid emulsion & LMWH begin with the day of ET Main results and the role of chance Chemical pregnancy was higher in the interventional group (54.0%) than the control group (40.0%) but without statistical significance (P = 0.161). Also, ongoing pregnancy was higher in the interventional group (85.0%) than the control group (60.0%) but without statistical significance (P = 0.094). No significant difference was reported regarding clinical pregnancy (P = 0.943). Limitations, reasons for caution Wider implications of the findings Our results suggest a hopeful therapeutic protocol that may be used in such failed ART cases especially when no other reason can be found. But selecting which cases will benefit the most will need much further investigations. Trial registration number NCT03792997