Comparison the effects of letrozole on endometrial thickness and fertility outcome in endometriotic patients candidate for IVF
Design
Double blind clinical trial phase 3 ,with parallel groups which were chosen with envelop pocket A or B by patients for randomization.
Settings and conduct
All infertile endometriotic patients who are Candidate for IVF will be allocated in letrozole or placebo groups from day2-7 of cycle,when the fix antagonist cycle of ovarian stimulation is started.Both patients and caregivers are blinded regarding the groups, and they were randomized with envelope containing A or B letter.
Intervention group: Two tablets of letrozole will be used from second day of induction ovulation and continued for five days then induction continued by fixed antagonist protocol
Control group : Two tablets of placebo will be used from second day of induction ovulation and continued for five days then induction continued by fixed antagonist protocol
Main outcome variables
Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N26
Registration date:2022-09-13, 1401/06/22
Registration timing:prospective
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of letrozole on endometrial thickness in endometriosis parients who are candidate for IVF
Public title
The effect of letrozole on endometrial thickness in endometriosis IVF parients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
IVF Candidate
History of endometriosis
Exclusion criteria:
pathologic lesion in endometrial cavity
pathologic lesion in endometrial cavity; hypersensitivity to letrozole; liver disease
liver disease
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization rule: First 40 letters A and 40 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patients. In addition, interventions A (case group) or B (control group) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and care providers are blinded regarding the case and control groups with using placebo that is the same as letrozole regarding form and taste.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical sciences
Street address
Deputy of research-6th floor-central building of Tehran University of Medical sciences-Ghods avenue-Keshavarz Blvd-Tehran-Iran
City
Tehran
Province
Tehran
Postal code
۱۵۹۷۸۱۵۹۷۸۱۵
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.467
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Endometrial thickness
Timepoint
At the day of triggering(5days after ending intervention)
Method of measurement
By vaginal ultrasound
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
BhCG test
2
Description
Clinical pregnancy
Timepoint
Four weeks after embryo transfer
Method of measurement
Visualisation fetal heart rate by vaginal ultrasound
Intervention groups
1
Description
Intervention group: Two tablets of letrozole 2.5 mg(Aboureihan pharmaceutical) will be used from second day of induction ovulation and continued for five days then induction continued by fixed antagonist protocol at 5th day of induction and continued till follicle 18mm wiil be occurred in TVS, endometrial thickness will be evaluated, trigger of ovulation and OPU will be scacduled for next 36 hours .
Category
Treatment - Drugs
2
Description
Control group: Two tablets of placebo will be used from second day of induction ovulation and continued for five days then induction continued by fixed antagonist protocol at 5th day of induction and continued till follicle 18mm wiil be occurred in TVS, endometrial thickness will be evaluated, trigger of ovulation and OPU will be scacduled for next 36 hours .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF Clinic of Yas Hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital;North Nejatollahi avenue;Karim Khan zand Bridge;Villa street
City
Tehran
Province
Tehran
Postal code
1579781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, North Nejatollahi avenue, Karim Khan zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.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
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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi avenue, Karim Khan zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital,North Nejatollahi avenue, Karim Khan Zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi, Karim khan zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.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
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