Evaluation of the effects of using letrozole and methotrexate in comparison with the use of placebo and methotrexate on the management of tubal ectopic pregnancies
Design
Controlled Clinical Trial, with parallel groups, triple blinded, randomized by random allocation method
Settings and conduct
Yas Hospital patients
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age: 18 - 40 years old
- Ectopic tubal pregnancy
- BetaHCG levels less than 5000 IU/L
Exclusion criteria:
- Fetal heart rate
- hemodynamic instability
- Significant abdominal pain
- History of allergic reactions to methtrexate
- History of allergic reactions to letrozole and other aromatase inhibitor agents
- Hypercholesterolemia
- Heterotopic pregnancy
Intervention groups
Adding letrozole or placebo to methotrexate treatment
Main outcome variables
BetaHCG level changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130808014301N2
Registration date:2020-07-01, 1399/04/11
Registration timing:prospective
Last update:2020-07-01, 1399/04/11
Update count:0
Registration date
2020-07-01, 1399/04/11
Registrant information
Name
zahra rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 0002
Email address
rezaizah@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of adding letrozole to methotrexate on the management of tubal ectopic pregnancies at Yas Hospital
Public title
The effects of adding letrozole to methotrexate on the management of tubal ectopic pregnancies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tubal ectopic pregnancies
BetaHCG level less than 5000 IU/L
Exclusion criteria:
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
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.070
Health conditions studied
1
Description of health condition studied
Tubal ectopic pregnancy
ICD-10 code
O00.1
ICD-10 code description
Tubal pregnancy
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.