A prospective randomized controlled trial showing efficacy of luteal phase low molecular weight heparin in fresh non-donor IVF/ICSI cycles in women with previous implantation failures

摘要

Background: Implantation failure is a major challenge in in-vitro fertilization (IVF) cycles. The present study was undertaken to determine the immunomodulatory effects of heparin in patients with previous implantation failures undergoing assisted reproductive techniques (ART). Methods: This was a prospective randomized controlled trial with sample size of 100 patients who had history of at least one previously failed IVF/ICSI. Study group of 50 patients received heparin and 50 patients in control group received routine luteal phase support. Results: Primary outcome of the study was implantation rate (IR) which was 11.03% in the study group was and 5.48% in the control group (p=0.08). Biochemical pregnancy rate and clinical pregnancy rate in the study group was 18% and 12% in the control group (p=0.401). Calculated live birth was 5.15% and 3.42% in the study and control groups respectively (p=0.562). 11 babies were taken home from the study group and 6 from the control group (p=0.18). Conclusions: The result of this pilot study showed relative increase in implantation rates (IR) suggesting beneficial effects of heparin in patients with repeated implantation failures. Although these changes are not statistically significant, the presence of an increasing trend in all the outcome parameters signify the possible benefits of heparin proving for the present study hypothesis.