Specific Objectives of the Dissertation use of Letrozole and metotrexate for treatment of ectopic pregnancy compared with metotrexate
Design
Admission of Patients with EP and divided two group .first group treatment by metotrexate And second group treatment by metotrexate + letrozole And compare two groups with outcome to decrease BHCG Titration
Settings and conduct
In Gynecology Ward Admission of Patients with EP and divided two group .first group treatment by Metotrexate 50 mg/m2 And second group treatment by Metotrexate + letrozole 10mg in first day second day thired day and measuring BHCG Titration in 4 and 7 day And compare two groups with outcome to decrease BHCG Titration by 15% and check of BHCG weekly to immeasurable BHCG
Participants/Inclusion and exclusion criteria
Inclusion Criteria
18=<Age<=50
βHCG <=5000
ectopic pregnancy Positive(Sonography Criteria )
Normal LFT
Stable of vital Signe
Ep<=3.5 cm
Absent of fetal heart rate
No Contraindicated of MTX
Exclusion Criteria
Breast feeding
positive FHR
Intervention groups
letrozole and metotrexate user for treatment of ectopic pregnancy compared with only metotrexate
Main outcome variables
First outcome :measuring BHCG Titration weekly to immeasurable BHCG
second outcome:Treatment of complication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230403057811N1
Registration date:2023-07-08, 1402/04/17
Registration timing:registered_while_recruiting
Last update:2023-07-08, 1402/04/17
Update count:0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
Narjes Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5592 9540
Email address
morel607@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
use of Letrozole And Metotrexate for treatment of ectopic pregnancy compared with Metotrexate at Shahid akbarabadi hospital
Public title
Effect of Letrozole in Ectopic Pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ectopic pregnancy Positive(Sonography Criteria )
Ep<=3.5 cm
Absent of fetal heart rate
βHCG <=5000
stable of vital signe
Exclusion criteria:
treatment of ectopic pregnancy by surgicall
fetal heart rate Positive
Sensitivity of Letrozole
breast feeding
Failuer of kidney and liver function
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blind
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of school medicine -Iran Univercitiy of medical sciences
Street address
Tehran Hemat highway next to Milad tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-11-23, 1400/09/02
Ethics committee reference number
IR.IUMS.FMD.REC.1400.502
Health conditions studied
1
Description of health condition studied
Ectopic Pregnancy
ICD-10 code
O00.9
ICD-10 code description
Ectopic pregnancy
Primary outcomes
1
Description
Decrease off BHCG Titration
Timepoint
In 4,7 Day if Decrease off BHCG Titration Check off BHCG Weekly
Method of measurement
ELISA Method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : Patient by Ectopic Pregnancy Treatment by only MTX
Category
Treatment - Drugs
2
Description
Intervention group 2: Patient by Ectopic Pregnancy Treatment by MTX And Letrozole
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Narjes Farahani
Street address
Akbarabadi Hospital Bagh Ferdos Station , Molavi Ave ,Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5563 4949
Email
morel607@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences next to Milad Tower Hemat Highway ,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Assistant Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University of Medical Sciences
Full name of responsible person
Narjes Farahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
no ,12,heydari Avenue Karimi Shirazi st ,Shahre rey
City
Tehran
Province
Tehran
Postal code
1874769514
Phone
+98 21 5592 9540
Email
msafari688057@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Narges Farahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
no ,12,heydari Avenue Karimi Shirazi St ,Shahre rey
City
Tehran
Province
Tehran
Postal code
1874769514
Phone
+98 21 5592 9540
Email
morel607@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Narjes Farahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
no ,12,heydari Avenue Karimi Shirazi St ,Shahre rey
City
Tehran
Province
Tehran
Postal code
1874769514
Phone
+98 21 5592 9540
Email
morel607@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available