Determination of the effect of letrozole on endometrial thickness in transvaginal ultrasound in IVF candidate patients
Design
Phase 3 clinical trial with a control group, with a parallel design, double-blind, is conducted on 100 patients using the random allocation rule.
Settings and conduct
This randomized study will be performed on 100 patients with IVF indication in Yas Hospital with a convenient sampling method. This is a double-blind study, the patient and analyzer do not know the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Women diagnosed with infertility
- Women who are candidates for IVF
Exit criteria:
-Pregnancy
- Presence of endometrial pathological lesions
- The person's lack of consent to participate in the study
- Intolerance of letrozole in the patient
- Presence of letrozole contraindications in patients such as liver diseases
Intervention groups
The case group receives 2.5 mg of letrozole daily from the third day of the menstrual cycle for 5 days.
Main outcome variables
The thickness of the uterine endometrium,Biochemical pregnancy,Clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120104008611N14
Registration date:2023-07-19, 1402/04/28
Registration timing:prospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of letrozole on endometrial thickness in IVF candidate patients at Yas Hospital infertility clinic
Public title
the effect of letrozole on endometrial thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women diagnosed with infertility
IVF candidate women
Exclusion criteria:
pregnancy
Presence of endometrial pathological lesions
The person's lack of consent to participate in the study
Intolerance of Letrozole in the patient
Presence of Letrozole contraindications in patients such as liver diseases
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 50 letters A and 50 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 patient. In addition, interventions A (letrozole) or B (clomiphene) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed double-blind, the participants, and the analyzer do not know the type of treatment. The participants, because of placebo usage, do not know the type of their treatment. Also, the analyzer does not know about the treatment group codes in the SPSS datasheet.
Placebo
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 Sciences
Street address
Pour Sina St
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2022-04-21, 1401/02/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.467
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Assess endometrial thickness
Timepoint
The second or third day of the menstrual cycle
Method of measurement
sonography
Secondary outcomes
1
Description
Biochemical pregnancy
Timepoint
Once, 14 days after fetus transfer
Method of measurement
Blood sampling
2
Description
Clinical pregnancy
Timepoint
Once, 6 to 8 weeks after embryo transfer
Method of measurement
Observation of pregnancy sac and heart rate on ultrasound
Intervention groups
1
Description
Intervention group:Patients receive letrozole 2.5 mg daily for 5 days from the third day of the menstrual cycle.
Category
Treatment - Drugs
2
Description
Control group: People receive daily placebo for 5 days from the third day of the menstrual cycle.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Hamideh Pakniat
Street address
Yas hospital, Next to the sarv street, North Nejatollahi street, karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
hpakniat@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Sahraiyan
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3689
Email
vcr@tums.ac.ir
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
Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
4321102589
Phone
+98 28 3333 6001
Fax
+98 28 3324 2661
Email
pakniat110@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
4321102589
Phone
+98 28 3333 6001
Fax
+98 28 3324 2661
Email
pakniat110@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
4321102589
Phone
+98 28 3333 6001
Fax
+98 28 3324 2661
Email
pakniat110@yahoo.com
Web page address
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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified participants.
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Pakniat, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Pakniat
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Pakniat