Evaluating the efficacy of letrozole in treating ectopic pregnancy and comparing its effect with methotrexate treatment
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 on 75 patients, random table was used for randomization.
Settings and conduct
As a patient diagnosis in the women's department of Waliasr Hospital (AJ) of Tehran University of Medical Sciences
Participants/Inclusion and exclusion criteria
A pregnant woman diagnosed with an ectopic pregnancy is a candidate for drug treatment/
Intervention groups
The first group received methotrexate in a single dose
The second group received letrozole in a 10-day period, once a day
The third group received letrozole for a period of 5 days, 2 pills a day
Main outcome variables
BHCG level and rate of ectopic pregnancy treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220902055855N1
Registration date:2023-04-13, 1402/01/24
Registration timing:prospective
Last update:2023-04-13, 1402/01/24
Update count:0
Registration date
2023-04-13, 1402/01/24
Registrant information
Name
saeedeh Eslami khotbesara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4428 0054
Email address
saedeh_eslami2001@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of letrozole in the treatment of ectopic pregnancy and comparing its therapeutic effect with methotrexate
Public title
Investigating the effect of letrozole in the treatment of ectopic pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients diagnosed with ectopic pregnancy who are candidates for medical treatment
Exclusion criteria:
Unstable patients and candidates for surgical treatment
The presence of fetal heart activity in the gestational sac
BHCG level is more than 3000
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
In this non-blinded clinical trial with the control group patients randomly will divide into 3 groups according to the above items. There are 25 patients in each group using the randomization method of thetable of numbers of vital statistics reference books in such a way that the numbers 1 to 25 belong to the first group, and the numbers 26 to 50 belong to the second group and the numbers 51-75 belong to the third group. The analyst is blinded to the group allocation, but the researcher and the patient are not blinded in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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 science
Street address
Keshavarz Blvd., Imam Khomeini Hospital (RA), Women's Department of Valiasr Hospital
City
Tehran
Province
Tehran
Postal code
14197 33141
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.093
Health conditions studied
1
Description of health condition studied
Ectopic pregnancy
ICD-10 code
O00
ICD-10 code description
Ectopic pregnancy
Primary outcomes
1
Description
decreased bhcg trend
Timepoint
First, seventh, fourteenth day
Method of measurement
Use of defined laboratory criteria
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group received letrozole with the brand name Letrofem 2.5 mg orally by Iran Hormon Company for a period of 10 days, two oral doses in the morning at the same time.
Category
Treatment - Drugs
2
Description
The first intervention group received letrozole with the brand name Letrofem 2.5 mg orally by Iran Hormon company for a period of 5 days, three times a day in the morning.
Category
Treatment - Drugs
3
Description
The control group received methotrexate from Razavi Pharmaceutical Company, 50 mg per square meter of body surface as a single intramuscular dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital (RA) complex
Full name of responsible person
Saeedeh Eslami Khotbesara
Street address
Keshavarz Boulevard, Imam Khomeini Hospital (RA)
City
Tehran
Province
Tehran
Postal code
14197 33141
Phone
+98 911 283 3673
Email
saedeh_eslami2001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeedeh Eslami khotbesara
Street address
Tehran، keshavarz Blvd,Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
331411497
Phone
+98 21 6119
Email
saedeh_eslami2001@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Tarafdari manshadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Boulevard, Imam Khomeini Hospital (RA)
City
Tehran
Province
Tehran
Postal code
14197 33141
Phone
+98 21 6119
Email
tarafdari@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Tarafdari manshadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Boulevard, Imam Khomeini Hospital (RA)
City
Tehran
Province
Tehran
Postal code
14197 33141
Phone
+98 21 6119
Email
tarafdari@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeedeh Eslami Khotbesara
Position
Obestetrics& Gynecology Surgery Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Boulevard, Imam Khomeini Hospital (RA)
City
Tehran
Province
Tehran
Postal code
14197 33141
Phone
+98 21 6119
Email
saedeh_eslami2001@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to not starting the study and uncertain results of the stuxy.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available