Comparison of pregnancy rate after frozen embryo transfer in two methods of endometrial preparation: using GnRH agonist together with letrozole and GnRH agonist alone in women with recurrent implantation failure
The effect of GnRH agonist with letrozole in frozen transfer in women with recurrent implantation failure
Design
In this randomized clinical trial involving 60 women (18-40 years), two groups were randomly assigned.
-Method used to generate random allocation sequence by mentioning the name of the software or site used: Computer random assignment list produced with PASS software.
Settings and conduct
This study is conducted at the Milad Infertility Center on infertile women with a history of two failed transfers. In one group, GnRH agonist, and letrozole were used two months before the transfer, and in the other group, the GnRH agonist protocol alone was used in the frozen embryo transfer. Blinding was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Infertile women (18-40 years) with a history of at least two failed embryo transfers and at least 5 good-quality embryos have been transferred.
lack of confirmed endometriosis and Endometrioma.
Exclusion criteria include:
patient dissatisfaction during treatment to continue the study and the presence of pathology endometrial
Intervention groups
Intervention group: In the intervention group, treatment with GnRH agonist, decapeptyl ampoule with a dose of 3.75 mg intramuscular (Varian Pharmed Pharmaceutical Company) along with letrozole 5 mg daily (Iran Hormone Pharmaceutical Company) is prescribed for two months and during the next period if suppression of ovaries and uterus is confirmed, treatment with oral estradiol is started. In the control group, the GnRH agonist (decapeptyl intramuscular injection with a dose of 3.75 mg) was started on the 21st day of the previous cycle, and the treatment with estradiol was prescribed on the second day of menstruation.
Main outcome variables
chemical pregnancy rate, Clinical pregnancy rate, ongoing pregnancy rate, and abortion rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181030041503N7
Registration date:2023-11-02, 1402/08/11
Registration timing:registered_while_recruiting
Last update:2023-11-02, 1402/08/11
Update count:0
Registration date
2023-11-02, 1402/08/11
Registrant information
Name
Malihe Mahmoudinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9878
Email address
mahmoudiniam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2024-03-29, 1403/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pregnancy rate after frozen embryo transfer in two methods of endometrial preparation: using GnRH agonist together with letrozole and GnRH agonist alone in women with recurrent implantation failure
Public title
Effect of GnRH agonist and letrozole treatment in women with recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women (18-40 years) with a history of at least two failed embryo transfers and at least 5 good-quality embryos have been transferred.
Document of the normal uterine cavity
normal test of TSH, Prolactin and thrombophilia
lack of confirmed endometriosis and Endometrioma
Lack of fibroma greater than 4 centimeters.
Exclusion criteria:
patient dissatisfaction during treatment to continue the study
The presence of pathology endometrial
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
Infertile patients with a history of two unsuccessful transfers
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization.
-In this randomized clinical trial involving 60 women (18-40 years), two groups were randomly assigned.
Randomization will be by block method. In this study, 6 quadruple blocks (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) will be the sampling guide. Then the list of blocks will be written and numbers will be assigned to them, then random numbers between 1 to 6 (eg 1, 4, 5, etc.) will be selected using the numbers site.
http://www.graphpad.com/quickcalcs/index. cfm
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
Mashhad university of medical sciences Ethics committee
Street address
Imam Reza Hospital, Imam Reza St., Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9178943791
Approval date
2020-10-29, 1399/08/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.462
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
chemical pregnancy rate
Timepoint
2 week after embryo transfer
Method of measurement
BHCG
2
Description
The rate of clinical pregnancy
Timepoint
6 weeks after embryo transfer
Method of measurement
Sonography
3
Description
ongoing pregnancy
Timepoint
Continue pregnancy for up to 12 weeks
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, treatment with GnRH agonist, decapeptyl ampoule with a dose of 3.75 mg intramuscular (Varian Pharmed Pharmaceutical Company) along with letrozole 5 mg daily (Iran Hormone Pharmaceutical Company) is prescribed for two months and during the next period if suppression of ovaries and uterus are confirmed (including absence of cysts and thickness of the uterus less than 5 mm), treatment with oral estradiol is started.
Category
Placebo
2
Description
Intervention group: in the control group, the GnRH agonist (decapeptyl intramuscular injection with a dose of 3.75 mg) will be started on the 21st day of the previous cycle, and estradiol will be prescribed from the second day of menstruation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Infertility center
Full name of responsible person
malihe mahmoudinia
Street address
Imam Reza Hospital, Imam Reza St., Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9178943791
Phone
+98 51 3853 4021
Email
mahmoudiniam@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
malihe mahmoudinia
Street address
Imam Reza Hospital, Imam Reza St., Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9178943791
Phone
+98 51 3583 1204
Email
mahmoudiniam@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
malihe mahmoudinia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, Imam Reza St., Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9178943791
Phone
+98 51 3853 4021
Email
mahmoudiniam@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
malihe mahmoudinia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, Imam Reza St., Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9178943791
Phone
+98 51 3583 1204
Email
mahmoudiniam@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
malihe mahmoudinia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, Milad fertility Center, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9178943791
Phone
+98 51 3853 4021
Email
mahmoudiniam@mums.ac.ir
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