Comparison of treatment with letrozole and methotrexate in patients with ectopic pregnancy in Kowsar Qazvin hospital
Design
Clinical trials include a 24-person group receiving mtx for ep treatment and a 24-person group receiving letrozole for ep treatment. Without control group, parallel groups, data collection is blind. Random allocation is based on software allocation ra software, phase 2 on 48 patients.
Settings and conduct
This study will begin at Kowsar Hospital in Qazvin in 1401. Patients receiving MTX receive 50 mg / m2 of intramuscular methotrexate. We measure BHCG on the fourth day of the seventh day and then every week until zero. CBC, LFT and BUN measurements are also on the fourth day 0 and every week until zero BHCG. The other group will receive 2.5 mg of letrozole every 12 hours for 10 days. BHCG, CBC, LFT and BUN are the same as the previous group
Participants/Inclusion and exclusion criteria
Women with ectopic pregnancies can participate in this study if they have the following conditions:
The adnexal mass is less than four centimeters
Absence of active intra-abdominal bleeding
The person is healthy in terms of kidney health diseases
Lack of fetal heart activity
Hcg B level is less than 5000
Do not breastfeed
The conditions for not entering the study are as follows:
The disease is a candidate for surgery
Patient's dissatisfaction with participating in the study
Intervention groups
In this study, the intervention was therapeutic use of letrozole instead of methotrexate to treat EP in order to prevent liver and blood complications and to prevent adverse effects on patients' ovarian reserve.
Main outcome variables
The rate of BHCG drop on the seventh day compared to the fourth day; BHCG zeroing time; The effect of medication on blood platelets; The effect of drug therapy on liver enzymes; The effect of medication on the patient's BUN and Cr
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220411054497N1
Registration date:2022-10-03, 1401/07/11
Registration timing:prospective
Last update:2022-10-03, 1401/07/11
Update count:0
Registration date
2022-10-03, 1401/07/11
Registrant information
Name
Sanaz Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 6374
Email address
sanazmlk97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison evaluation of letrozol metoretoxate treatment in patients with ectopic pregnancy
Public title
Evaluation of the effectiveness of letrozole in EP treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of active intra-abdominal bleeding
Adnexal mass below four centimeters
The person is healthy in terms of liver and kidney disease
B-HCG levels should be less than 5000
The patient should not breastfeed
Exclusion criteria:
If the patient is a candidate for surgery
If the patient does not consent to participate in the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Not randomized
Randomization description
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 of committee of Qazvin University of Medical sciences
Street address
Bahonar
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2021-02-22, 1399/12/04
Ethics committee reference number
IR.QUMS.REC.1399.484
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
B-HCG
Timepoint
0 day fourth day and seventh day
Method of measurement
Blood test and B-HCG check request
2
Description
Duration of zeroing of B-HCG in the two groups of letrozole and methotrexate
Timepoint
From day one of B-HCG assay until the B-HCG marker is zero
Method of measurement
Blood test and B-HCG check request
Secondary outcomes
1
Description
Hbg
Timepoint
The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero
Method of measurement
Taking blood tests and checking CBC
2
Description
WBC
Timepoint
The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero
Method of measurement
Taking blood tests and checking CBC
3
Description
platelets
Timepoint
The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero
Method of measurement
Taking blood tests and checking CBC
4
Description
LFT
Timepoint
The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero
Method of measurement
Blood test and blood biochemistry check
5
Description
BUN
Timepoint
The first day of referral, the fourth day and the seventh day and then weekly until the BHCG is zero
Method of measurement
Blood test and blood biochemistry check
Intervention groups
1
Description
The intervention group: includes a group of 24 people receiving letrozole for the treatment of EP, after explaining the benefits and side effects of both treatment methods and obtaining informed consent from them, 2.5 mg tablets every twelve hours for ten days receive letrozole
Category
Treatment - Drugs
2
Description
The intervention group: includes a group of 24 people receiving methotrexate for the treatment of EP, who after explaining the benefits and complications of both treatment methods and obtaining informed consent from them, methotrexate ampoules with a dose of fifty mg per square meter It is done for them in a muscular way
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Dr. Fatemeh Lalouha
Street address
Taleghani Ave.
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6380
Email
Lalooha44@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Lalooha
Street address
Taleghani Ave
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6380
Email
sanazmlk97@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin University of Medical Sciences Research Assistant
Proportion provided by this source
100
Public or private sector
Private
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
Qazvin University of Medical Sciences
Full name of responsible person
Sanaz Maleki
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Bahonar Ave.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
sanazmlk97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Lalouha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kosar Hospital, Taleghani Ave.
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
lalooha44@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sanaz Maleki
Position
medical intern
Latest degree
A Level or less
Other areas of specialty/work
Others
Street address
Qazvin university of Medical science, Bahonar Ave.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
sanazmlk97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Only information from the study participants will be published that is relevant to the outcome of the study and that they have been informed of their consent prior to the start of the study.
When the data will become available and for how long
The access period started at the beginning of 1401 and continues until the examination of 24 patients receiving letrozole treatment
To whom data/document is available
This information is available in the early stages for researchers and university-level research supervisors
Under which criteria data/document could be used
This information is available in the early stages for researchers and university-level research supervisors
From where data/document is obtainable
To receive comments, you can refer to the main project manager and then the executive project manager
What processes are involved for a request to access data/document
Submitting a request to the research director After reviewing by the project manager, a request to the research vice chancellor of the university