Abstract

BACKGROUND The purpose of this study was to compare the success rates of 70 patients from the same database, each with an ectopic pregnancy (EP) that was treated with either the single- or multi-dose methotrexate (MTX) protocols for unruptured EPs. MATERIALS AND METHODS This study was a blinded, randomized clinical trial. Treatment protocols were either single- (50 mg/m(2)) dose MTX or multi-dose (1 mg/kg MTX + 0.1 mg/kg folinic acid). There were 35 cases in each group. The outcome was measured by adverse events, resolution of pregnancy without surgical treatment, success rate of MTX treatment, and fertility outcome in each group. RESULTS With the single-dose protocol, response to treatment was considered successful in 29 (82.9%) patients; in the multi-dose protocol 31 (88.6%) responded to treatment. The difference between success rates in the groups was not statistically significant (p=0.587). In the singledose group, 2 (5.7%) patients and in the multi-dose group, 6 (17.2%) patients had complications (p=0.28). Of the 14 patients in the single-dose group. Clinical pregnancy occurred in 9 (75%) whereas clinical pregnancy occurred in 3 (25%) patients from the multi-dose group. Infertility was seen in 4 (33.3%) patients in the single-dose group and in 8 (66.7%) in the multi-dose group. CONCLUSION We believe that the single-dose MTX protocol could be as successful as multi-dose MTX for the treatment of EP. It is effective, cost-effective, and associated with better fertility outcomes than the multi-dose MTX protocol (Registration Number: IRCT201112178435N1).