Using drugs with less side effects (letrozole and gonadotropin instead of estradiol) to prepare the uterus for frozen embryo transfer
Design
The clinical trial has a control group and a parallel group that is blinded on one side and individual and block randomization with RAS software on 108 patients.
Settings and conduct
This study is a one-sided blind clinical trial that is performed in the frozen embryo transfer cycle of patients referred to the infertility center of Mahdieh Hospital in Tehran. Patients will be randomly assigned to two groups receiving estradiol and the group receiving letrozole and HMG.
Participants/Inclusion and exclusion criteria
Intervention group: Women with frozen embryos who are in the embryo transfer cycle and are treated with letrozole and gonadotropin to prepare the uterine endometrium for embryo transfer, and when the thickness of the endometrium reaches the desired size (7 mm) and a dominant follicle Ovulation stimulation is done and depending on the age of the embryo, embryo transfer is done after a few days. Control group: women candidates for the frozen embryo transfer cycle are subjected to the usual treatment with estradiol tablets to prepare the endometrium to the desired size (7 mm) and the embryo transfer is performed.
Intervention groups
Intervention group: 18-42-year-old frozen embryo transfer candidate women without uterine anatomical disorders who are treated with letrozole and gonadotropin to prepare the uterine endometrium. Control group: 18-42-year-old frozen embryo transfer candidate women without uterine anatomical disorders. which are treated with estradiol pills to prepare the endometrium for embryo transfer.
Main outcome variables
Chemical and clinical pregnancy. abortion Appropriate thickness of the endometrium (cancellation or not of the cycle)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230514058176N1
Registration date:2023-06-19, 1402/03/29
Registration timing:prospective
Last update:2023-06-19, 1402/03/29
Update count:0
Registration date
2023-06-19, 1402/03/29
Registrant information
Name
samira azimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
drazimi48@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-21, 1402/03/31
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Hormone replacement therapy with ovarian stimulation as endometrial preparation protocols for frozen thawed embryo transfer
Public title
Comparison of Hormone replacement therapy with ovarian stimulation as endometrial preparation protocols for frozen thawed embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women referring to Mahdiyeh infertility treatment center aged between 18 and 42 years who have frozen embryos
Have a normal uterine structure
Have a healthy endometrium without endometrial polyps or submucosal myoma
Exclusion criteria:
anatomical malformation of uterus ; unicorn. bicorn
underlying disease like diabet. thyroid . cardiovascular. immun disease
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
184
More than 1 sample in each individual
Number of samples in each individual:
92
patient candidated for frozen embryo transfer
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be done in a randomized block fashion. Individual randomization unit is considered. RAS statistical software will be used for block randomization and also for determining the sequence of blocks. All patient information will be recorded in spss26 software.
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
Ethic committee of Shahid Beheshti University of Medical Science
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.084
Health conditions studied
1
Description of health condition studied
The method of endometrial preparation in the frozen embryo transfer cycle
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factor
Primary outcomes
1
Description
Endometrial thickness: The appropriate thickness of the endometrial layer of the uterus for embryo transfer, which is better to be above 6 to 7 mm to prepare for embryo transfer.
Timepoint
The thickness of the endometrium is measured before the start of the treatment and 7-14 days after the intervention.
Method of measurement
Endometrial thickness is measured by transvaginal ultrasound.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infertile women referred to the infertility treatment center of Mahdieh Hospital, who are in the cycle of frozen embryo transfer, and in order to prepare the endometrium on the third day of menstruation, letrozole tablets (Latrax 2.5 mg, Aburihan Pharmaceuticals) were taken once a day at night for 5 days. Human menopausal gonadotropin (HMG 75 IU) ampoule will be injected intramuscularly once a day for three days. Then a control ultrasound is performed and if the follicle is 17 to 22 mm and the thickness of the endometrium is 6 to 7 mm, the human chorionic gonadotropin ampoule will be administered. (HCG 5000 IU) is injected intramuscularly. 36 hours later, 50 mg progesterone ampoule (Abourihan Company) will be injected intramuscularly for 3 days in the case of three-day-old embryos and 5 days in the case of 5-day-old embryos, and then embryo transfer is performed and two weeks after the transfer, a pregnancy test will be performed.
Category
Treatment - Drugs
2
Description
Control group: Infertile women referred to the infertility treatment center of Mahdieh Hospital, who are in the cycle of frozen embryo transfer, who receive 2 mg estradiol pills (Aburihan Company) three times a day (every 8 hours) to prepare the endometrium on the third day of menstruation. one number) then a control ultrasound is performed and if the follicle reaches 17 to 22 mm and the endometrium thickness reaches 6 to 7 mm, 100 mg progesterone ampoule (Aburihan company) for 3 days in the case of 3-day and 5-day embryos In the case of 5-day-old embryos, the day is injected, and then embryo transfer is performed, and two weeks later, a pregnancy test is performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh hospital
Full name of responsible person
Samira Azimi
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419943471
Phone
+98 21 23871
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
Samira Azimi
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
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
drazimi48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samia Azimi
Position
infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
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
drazimi48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samira Azimi
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
00989 21 55062628
Email
drazimi48@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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