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IRCT20130808014301N2 IRCT 2020-07-01 Tehran University of Medical Sciences The effects of adding letrozole to methotrexate on the management of tubal ectopic pregnancies The effects of adding letrozole to methotrexate on the management of tubal ectopic pregnancies at Yas Hospital 2020-07-22 anticipated 90 Complete https://irct.ir/trial/49182 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation, there are 45 small envelopes containing letter A and 45 small envelopes in the same shape containing letter B in a bag; and for each patient one envelope is selected randomely, Blinding description: Placebo and letrozole tablets are in the same shape and depending on the patient's group name (A or B) are given to the patient's nurse by the responsible doctor; thus the patient and the nurse are blinded. In addition, outcome observer physician, data collector, and data analyzer are blinded and they don't know which intervention is used for each group. N/A Tubal ectopic pregnancy. Intervention 1: Intervention group: The main treatment is a single dose of 50 mg/m2 intramuscular methotrexate injection. By the day of methotrexate injection, the interventional treatment as Abureyhan Co. 2.5 milligram letrozole tablets - 4 tablets daily - is prescribed orally for seven days. Intervention 2: Control group: The main treatment is a single dose of 50 mg/m2 intramuscular methotrexate injection. By the day of methotrexate injection, the interventional treatment as Abureyhan Co. placebo tablets - 4 tablets daily - is prescribed orally for seven days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr. Zahra Khalaj Sereshki
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8890 0002 zahrakhalaj@yahoo.com Tehran University of Medical Sciences scientific Dr Zahra Khalaj Sereshki
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
Tehran Iran (Islamic Republic of) 1598718311 +98 21 8890 0002 zahrakhalaj@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Tubal ectopic pregnancies BetaHCG level less than 5000 IU/L 18 years 40 years Female Fetal heart rate Hemodynamic instability Significant abdominal pain History of allergic reactions to methotrexate History of allergic reactions to letrozole and other aromatase inhibitor agents hypercholesterolemia Liver enzymes abnormalities Abnormal renal function tests Heterotopic pregnancies O00.1 Tubal pregnancy Treatment - Drugs Placebo Intervention group: The main treatment is a single dose of 50 mg/m2 intramuscular methotrexate injection. By the day of methotrexate injection, the interventional treatment as Abureyhan Co. 2.5 milligram letrozole tablets - 4 tablets daily - is prescribed orally for seven days. Control group: The main treatment is a single dose of 50 mg/m2 intramuscular methotrexate injection. By the day of methotrexate injection, the interventional treatment as Abureyhan Co. placebo tablets - 4 tablets daily - is prescribed orally for seven days. Blood beta-HCG level changes. Timepoint: Before, and 4 and 7 days after beginning of the treatment, then weakly until the negative test. Method of measurement: blood test. Tehran university of medical sciences Approved 2020-05-20 Ethics committee of Tehran University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)