Comparison of ovarian response to ovulation stimulation with letrozole tablets by 20 mg and 5-day methods
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients. Excel software "rand" function was used for randomization.
Settings and conduct
Patients visit one to three cycles a day and receive one of the treatments randomly. Then the patient performs transvaginal ultrasound on days 9 to 11 of the cycle. The size of the follicles and the thickness of the endometrium are checked. The number of HMG ampoules is prescribed and again two days later the patient will have an ultrasound. The number of observed follicles and the diameter of the largest observed follicle will be recorded. If a follicle above 14 mm is seen, the patient is followed by a follicle in the size of 19-18 mm HCG and 36 hours later IUI is performed. Then the results will be recorded and compared in two groups. The amount of HMG consumed will also be recorded will be. The patient is given a letter to refer to Mahdieh Hospital in case of any emergency problems such as abdominal pain, nausea, vomiting, etc.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 40-20 years old; at least one year of infertility; no underlying disease. The spermogram was within acceptable range for IUI and at least one fallopian tube was open.
Exclusion criteria: history of allergy to letrozole and other aromatase inhibitors; cabergoline and other ergot derivatives; history of pelvic surgery and the presence of any factor other than infertility.
Intervention groups
Patients are divided into two random groups and will be given 20 mg of letrozole single dose or 5 times daily letrozole 3 times.
Main outcome variables
Number of follicles per day 9 to 11 cycles; diameter of the largest follicle; HMG consumption; incidence of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220412054511N1
Registration date:2022-12-10, 1401/09/19
Registration timing:prospective
Last update:2022-12-10, 1401/09/19
Update count:0
Registration date
2022-12-10, 1401/09/19
Registrant information
Name
Elham Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6605 6115
Email address
helham260@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of letrozole administration to stimulate ovulation in IUI cycles by two methods of 20 mg single dose and 5 days
Public title
Letrozole for IUI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have a history of at least one year of infertility
Absence of underlying disease including abnormal thyroid stimulating hormone prolactin
Spermogram within acceptable range for IUI
At least one fallopian tube is open.
Exclusion criteria:
History of allergy to letrozole and other aromatase inhibitors
History of allergy to cabergoline and other ergot derivatives
History of pelvic surgery
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using randomization software
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind and the patient and the researcher do not know which group the patient belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Koodakiar street, Tehran
City
Tehran
Province
Tehran
Postal code
146367
Approval date
2022-11-05, 1401/08/14
Ethics committee reference number
IR.SBMU..MSP.REC.1401.375
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
Ovarian response (the number of follicle with size more than 14 millimeter)
Timepoint
The day 9 to 11 of menstruation cycle
Method of measurement
Vaginal ultrasound
2
Description
Ovarian response (the size of biggest follicle)
Timepoint
The day 9 to 11 of menstruation cycle
Method of measurement
Vaginal ultrasound
3
Description
Endometrial thickness
Timepoint
The day 9 to 11 of menstruation cycle
Method of measurement
Vaginal ultrasound
4
Description
The number of HMG ampoules required
Timepoint
from day 11 to 13 menstruation cycle
Method of measurement
Medical record
Secondary outcomes
1
Description
Pregnancy (Positive BHCG test)
Timepoint
Two weeks after IUI (intra uterine insemination)
Method of measurement
Blood test
2
Description
Abortion
Timepoint
During 3 months after pregnancy confirmation
Method of measurement
Getting out of pregnancy products (direct observation or ultrasound)
Intervention groups
1
Description
Intervention group: Women candidates for IUI who will receive a single dose of Letrozole 20 mg tablet
Category
Treatment - Drugs
2
Description
Control group: Women candidates for IUI who will receive 5 mg of Letrozole tablets daily for 5 days from the third day of the cycle (common approach)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh Hospital
Full name of responsible person
Zahra Heidar
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://mmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zaraghi
Street address
Shahid Beheshti University of Medical Sciences, Koodakiar street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti University of Medical Sciences, Koodakiar street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 6605 6115
Fax
Email
helham260@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti University of Medical Sciences, Koodakiar street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 6605 6115
Fax
Email
helham260@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Hashemi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti University of Medical Sciences, Koodakiar street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 6605 6115
Fax
Email
helham260@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
6 months after publication
To whom data/document is available
For researchers working in academic and scientific institutions and people working in industry
Under which criteria data/document could be used
The data of this study can be used for meta-analysis.
From where data/document is obtainable
The applicant for the information must send an email in English containing the name and how to use this data to the executor's email address.
helham260@gmail.com
What processes are involved for a request to access data/document
The applicant for the information must send an email in English containing the name and how to use this data to the executor's email address. Information will be sent to them within 10 working days of sending the email.