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Investigating the success rate of aromatase inhibitor (letrozole) in the treatment of ectopic pregnancies compared to methotrexate.

Protocol summary

Study aim
Determination of the success rate of aromatase inhibitor (letrozole) in the treatment of ectopic pregnancy compared to methotrexate
Design
A clinical trial, with parallel groups, double-blind, randomized, phase 2 on 40 patients
Settings and conduct
40 people are selected from among the people who referred to the hospital in whom ectopic pregnancy was proven. Checklist of demographic and laboratory information is completed.Patients will be divided into two equal groups of 20 to receive letrozole or methotrexate. BHCG levels will be checked in both groups on the first day of treatment and on days 4, 7, and 14 after treatment. The selection of patients is done by a doctor other than the researcher, and the researcher is not aware of how the patients are divided based on the type of medicine received. However, the choice of the type of medicine is made based on whether the file number is even or odd, thus, the patient is not aware of the type of medicine received
Participants/Inclusion and exclusion criteria
Entry requirements : 1. Proven ectopic pregnancy 2. The age of the patient is 18-40 years 3. Laboratory standards Non-entry conditions: 1. Instability of vital signs and occurrence of symptoms based on internal bleeding 2. Presence of surgical indication 3. Contraindications for use of letrozole or methotrexate
Intervention groups
Patients are divided into two equal groups of 20 people to receive letrozole or methotrexate. In the group receiving methotrexate, a single dose of methotrexate will be calculated with a dose of 50 mg per square meter of the body. In the group receiving letrozole, 2.5 mg tablets are prescribed twice a day for 10 consecutive days.
Main outcome variables
BHCG test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170828035961N2
Registration date: 2023-07-01, 1402/04/10
Registration timing: registered_while_recruiting

Last update: 2023-07-01, 1402/04/10
Update count: 0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Farahnaz Mardanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3693 2380
Email address
mardanian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the success rate of aromatase inhibitor (letrozole) in the treatment of ectopic pregnancies compared to methotrexate.
Public title
Investigation of the effect of letrozole in the treatment of ectopic pregnancies compared to methotrexate.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Proven ectopic pregnancy(EP) Patient age 18-40 years Serum level (BHCG) beta Human Chorionic Gonadotropin less than 5000 Serum hemoglobin level above 10 Serum platelet level above 150,000
Exclusion criteria:
unstability of vital signs and occurrence of symptoms related to internal bleeding. The presence of surgical indications (viewing the fetal heart, abdominal EP(ectopic pregnancy), size above 3.5 cm, EP rupture and abdominal bleeding) Contraindications for use of letrozole or methotrexate (chronic kidney, liver and blood diseases, immunodeficiency, breastfeeding, active lung disease, peptic ulcer, simultaneous intrauterine pregnancy, drug interactions, severe drug sensitivity)
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 40 eligible ectopic pregnant will be selected randomly. Then the letters A and B are written on 20sheets and each one is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two drugs, letrozole and methotrexate, are placed in coded packages by the pharmacy manager and delivered to the researcher, who is unaware of the type of each. Medications are prescribed. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences.
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Esfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-10-06, 1400/07/14
Ethics committee reference number
IR.MUI.MED.REC.1400.559

Health conditions studied

1

Description of health condition studied
Ectopic pregnancy.
ICD-10 code
O00.9
ICD-10 code description
Ectopic pregnancy, unspecified

Primary outcomes

1

Description
Serum levels of beta Human Chorionic Gonadotropin(BHCG)
Timepoint
The first day of treatment and days 4, 7 and 14 after treatment
Method of measurement
BHCG test.

Secondary outcomes

1

Description
Serum levels of liver enzymes
Timepoint
The first day of treatment and 7 days after that
Method of measurement
Blood test

2

Description
Serum levels of creatinine
Timepoint
The first day of treatment and 7 days after that
Method of measurement
Blood test

3

Description
Serum hemoglobin level
Timepoint
The first day of treatment and 7 days after that
Method of measurement
Blood test

4

Description
Counting the number of blood platelets
Timepoint
The first day of treatment and 7 days after that
Method of measurement
Blood test

5

Description
Anti-Müllerian hormone serum level
Timepoint
The first day of treatment and 3 months after that
Method of measurement
Blood test

6

Description
Drug side effects
Timepoint
while taking medication
Method of measurement
check list

7

Description
History of ectopic pregnancy
Timepoint
The beginning of treatment
Method of measurement
check list

8

Description
Number of pregnancies
Timepoint
The beginning of treatment
Method of measurement
check list

Intervention groups

1

Description
Intervention group: In the group receiving methotrexate, a single dose of methotrexate with a dose of 50 mg per square meter of the body will be calculated and injected intramuscularly or subcutaneously.
Category
Treatment - Drugs

2

Description
Intervention group: In the group receiving letrozole, 2.5 mg tablets are prescribed twice a day for 10 consecutive days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti Hospital.
Full name of responsible person
Farhanaz Mardanian
Street address
Shahid Beheshti Hospital, Shahid Motahari Street
City
Esfahan
Province
Isfehan
Postal code
8184853542
Phone
+98 31 3236 3500
Email
fmardani2005@yahoo.com

2

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Farhanaz Mardanian
Street address
Al-Zahra Hospital; Sofeh boulevard
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
fmardani2005@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Farhanaz Mardanian.
Position
Professor, specialist doctor of the academic staff.
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti Hospital, Shahid Motahari Street
City
Esfahan
Province
Isfehan
Postal code
8184853542
Phone
009832363500
Email
fmardani2005@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Farhanaz Mardanian
Position
Professor, specialist doctor of the academic staff
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti Hospital, Shahid Motahari Street
City
Esfahan
Province
Isfehan
Postal code
8184853542
Phone
+98 31 3236 3500
Email
fmardani2005@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Farhanaz Mardanian
Position
Professor, specialist doctor of the academic staff
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti Hospital, Shahid Motahari Street
City
Esfahan
Province
Isfehan
Postal code
8184853542
Phone
+98 31 3236 3500
Email
fmardani2005@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
There is no further information
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
No - There is not a plan to make this available
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