Comparing the mannitol and albumin in management of the severe ovarian hyperstimulation syndrome (OHSS), a randomized clinical trial, with cost-effectiveness analysis

Abstract

Background: Ovarian hyperstimulation syndrome (OHSS) is potentially life-threatening complication including pleural effusion, acute renal insufficiency, and venous thromboembolism associated with controlled ovarian stimulation during assisted reproductive technology. A number of clinical studies have reported on the use of plasma expanders such as albumin, hydroxyethyl starch (HES), mannitol, polygeline and dextran as a possible intervention for the prevention of OHSS. Objective: The purpose of this study was to compare the efficacy and cost-effectiveness of mannitol rather than albumin for the treatment of severe OHSS. Materials and Methods: We conducted a single-center and comparative randomized clinical trial with two parallel patient groups. 47 patients with severe OHSS were selected with inclusion criteria. In albumin group (n=26), patients received 100 g/day intravenous albumin. Mannitol therapy (n=21) started twice a day using 100 gr mannitol infusion over 4 hours. Patients were monitored according to the standard protocol. Statistical analysis will be performed to analyze and compare the data between two groups in order to determine the efficacy (based on vital sign, abdominal circumference, weight, intake/output of fluid, correction of hemoconcentration), side effects and cost of drug therapy between the two treatment modalities. Results: The efficacy of drug therapy was evaluated by examining the results of daily urine output, serum biochemistry analytes, weight and abdominal circumference in both group. There were no significant differences between the two study groups in terms of patient age, clinical signs and symptoms, and laboratory findings such as hematocrit, creatinine, oliguria, weight, and abdominal size. Significant improvement of OHSS syndrome was observed in patients using mannitol which no patient was reported any side effects such as respiratory distress syndrome, renal failure, or thromboembolism. In the albumin group, 15.38 % of patients presented with acute respiratory distress syndrome (ARDS). Another outcome of this study was the significant economic difference between the two managements of severe ovarian hyperstimulation syndrome. Mannitol therapy was obviously cost-effective versus albumin therapy. Conclusion: The use of mannitol is comparable and superior to albumin for the treatment of severe OHSS with regard to the protective effect against the occurrence of acute respiratory distress syndrome. Base on this study, its cost-effectiveness makes mannitol an ideal drug for OHSS treatment. This study suggests that mannitol can be first-line therapy for the treatment of severe OHSS, therefore, the addition of mannitol as a treatment of ovarian hyperstimulation syndrome is recommended in the pharmacopeia.