Comparison of endometrial preparation with estradiol and letrozole in IVF cycles
Design
Two arm parallel group randomised trial with blinded treatment.
Settings and conduct
This study is conducted in Akbarabadi Hospital on women aged 18 to 42 with frozen embryos. In this study, women are divided into two control and intervention groups.
Participants/Inclusion and exclusion criteria
Women 18 to 42 years old with high-quality 6 to 8 cells frozen embryos
Intervention groups
89 women aged 18 to 42 years were given 5 mg of letrozole daily on the 3rd-7th day of menstruation to prepare the endometrium.
Main outcome variables
The effect of letrozole drug compared to estradiol drug on endometrial thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240521061861N1
Registration date:2024-07-08, 1403/04/18
Registration timing:retrospective
Last update:2024-07-08, 1403/04/18
Update count:0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Somayeh Ebadisoflo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3661 6706
Email address
ebadisoflo.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-28, 1403/02/09
Expected recruitment end date
2024-05-29, 1403/03/09
Actual recruitment start date
2024-04-28, 1403/02/09
Actual recruitment end date
2024-05-29, 1403/03/09
Trial completion date
2024-08-30, 1403/06/09
Scientific title
Comparison of endometrial preparation with estradiol and letrozol in IVF cycles returned from freezing
Public title
endometrial preparation with estradiol and letrozol in IVF cycles
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 42 with frozen embryos
Exclusion criteria:
Mother's underlying disease such as thrombophilia, uncontrolled diabetes, uncontrolled hyperprolactinemia, uncontrolled thyroid disorder.
Lack of informed consent to participate in the study
Hydrosalpinx
Having uterine anomaly and premature ovarian insufficiency (POF) and low quality embryos
Repeated implantation failure
Age
From 18 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
178
Actual sample size reached:
178
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the participants will be placed in two intervention and control groups by block randomization method, each group will include 89 participants. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. The difference in the number of people in each group will never be more than half of the number of people in each block. Block randomization will be done using a table of random numbers.
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 committee of Iran University of Medical sciences
Street address
Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-06-08, 1403/03/19
Ethics committee reference number
IR.IUMS.FMD.REC.1402.155
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Investigating the effect of oral letrozole administration on endometrial thickness
Timepoint
From the third to the fifth day of menstruation until the tenth day
Method of measurement
Transvaginal ultrasound
2
Description
Investigating the effect of oral estradiol administration on endometrial thickness
Timepoint
From the second day to the tenth day of menstruation
Method of measurement
Transvaginal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: including 89 women aged 18 to 42 who meet the conditions to enter the study. In order to prepare the endometrium, on day 3-7 of menstruation, 5 mg of letrozole is given daily, and on day 10, transvaginal ultrasound is performed, and if the follicle size is greater than 14, serial ultrasound is performed. If the size of the follicle reaches 18 to 20 mm and the thickness of the endometrium reaches 8 mm and the tree line is reached, and the estradiol level is above 150 pg, hCG 10000 IU ampoule is given, and after 36-48 hours, we start progesterone suppository 400 mg every 12 hours. The next day, embryo transfer is done. If the size of the follicle is less than 14 mm on the 10th day, hmg is injected daily for two to three days. And when the follicle is 18 mm and the estradiol level is above 150, then hCG is prescribed, and 3 days later, a three-day embryo transfer is performed, and a week after the embryo transfer, the progesterone level is checked, and if it is below 20 nanomoles, progesterone suppositories are given. If there is no dominant follicle on the 17th day and if the thickness of the endometrium does not reach the desired size during serial transvaginal ultrasound or if the estradiol level is less than 150 pg, the cycle will be canceled.
Category
Treatment - Drugs
2
Description
Control group: including 89 women aged 18 to 42 who meet the conditions to enter the study. From the second day of the menstrual cycle, 3 tablets (2 mg three times a day) of oral estradiol are given. From the 10th day, the thickness of the endometrium is checked serially with vaginal ultrasound. If the thickness of the endometrium is 7-8 mm, in addition to giving estradiol, progesterone suppository 400mg every 12 hours is started for the patient, and 3 days later, the transfer of a three-day-old embryo is carried out under the guidance of ultrasound. is done A pregnancy test will be done two weeks later. If it is positive, estradiol is stopped and progesterone suppositories are continued twice a day until the gestational age of W10. If the thickness of the endometrium is less than 8 or the endometrium does not have three lines by the 16th day, the cycle will be canceled.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Somayeh Ebadi
Street address
Molavi Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh Ebadisoflou
Street address
Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Email
intl@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
10
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
Iran University of Medical Sciences
Full name of responsible person
Somayeh Ebadisoflou
Position
Gynecology and obstetrics specialist assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Email
ebadisoflo.s@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh EbadiSoflou
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Email
ebadisoflo.s@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Somayeh Ebadisoflou
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2030
Email
ebadisoflo.s@iums.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The data of this study can be useful for people who are experts in this field and those who are being treated for more information. Therefore, this data can be provided to people as an article.
When the data will become available and for how long
It is possible to start accessing the data 6 months after the results are published.
To whom data/document is available
Everyone will be allowed to read the article.
Under which criteria data/document could be used
The data obtained from this study can help obstetricians and gynecologists to choose a more beneficial treatment method for preparing the endometrium in frozen eggs. Therefore, experts and researchers can access these data and documents.
From where data/document is obtainable
ebadisoflo.s@iums.ac.ir
What processes are involved for a request to access data/document
The data will be accessible 6 months after the publication of the results.