Effect of adding long-acting GnRH agonist plus Letrozole to endometrial preparation method with Estradiol on pregnancy outcome in frozen embryo transfer cycles among women with recurrent implantation failure: A clinical trial
Determining the effect of adding long-acting GnRH agonist plus Letrozole to endometrial preparation method with estradiol on pregnancy outcome in frozen embryo transfer cycles among women with recurrent implantation failure.
Design
Phase 3 clinical trial is with two parallel groups and the sample size is 64 people. Randomization will be done using random allocation1 software. Block randomization method will be done. Blinding will not be done.
Settings and conduct
Clinical trial is random and without blinding. In Yazd Reproductive Research Center, 64 infertile women referred to this center who had a history of at least two repeated implantation failures despite quality A and B embryo transfer, were randomly divided into control group and case group. Blinding was not performed in this study.
Participants/Inclusion and exclusion criteria
Infertile 18 to 42 years old women with a history of at least two implantation failure of good quality embryos (A and B) who are candidate for frozen thawed embryo transfer cycle. Male factors are normal and the patient has no anomalous problems, no adenomyosis, no ectopic endometriosis.
Intervention groups
The control group just receive 6 mg of Estradiol valerate daily from the second day of the menstrual cycle. Patients in the case group will receive a monthly dose of Triptorelin 3.75 for up to two months plus 5 mg of Letrozole daily, and immediately after the end of two months of treatment they will enter the freeze embryo transfer cycle and start taking 6 mg of estradiol daily. In both groups, transvaginal sonography is performed on day 13 of the menstrual cycle, and after reaching an endometrial thickness of at least 7 mm, 400 mg of vaginal Progesterone twice daily with 6 mg of estradiol daily for three days until the day of embryo transfer will consume.
Main outcome variables
Chemical and clinical pregnancy rate, chemical abortion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053629N1
Registration date:2022-02-13, 1400/11/24
Registration timing:prospective
Last update:2022-02-13, 1400/11/24
Update count:0
Registration date
2022-02-13, 1400/11/24
Registrant information
Name
Sara Naghibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
sara_naghib848@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adding long-acting GnRH agonist plus Letrozole to endometrial preparation method with Estradiol on pregnancy outcome in frozen embryo transfer cycles among women with recurrent implantation failure: A clinical trial
Public title
Effect of adding long-acting GnRH agonist plus Letrozole to frozen embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 42 years old infertile women
The history of at least two implantation failure of good quality embryos (A and B)
Frozen thawed embryo transfer cycle
Candidate for embryo transfer with A and B grade
Exclusion criteria:
Severe male factor or sperm retrieval except ejaculation
Endometriosis in previous sonography or laparascopy
Severe adenomiosis in sonography
History of myoma surgery or any interfering myoma with implantatio
History of implantation failure because of thin endometrium
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:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of samples in the two groups will be done using permutation block method using Random allocation 1 software. 8 blocks with a size of 8 samples are considered. For allocation concealment, sealed envelopes for each person is used.
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 Yazd Reproductive Institute, Shahid Sadoughi University of medical sciences
Street address
Bouali Ave, Safaeiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2021-12-19, 1400/09/28
Ethics committee reference number
IR.SSU.RSI.REC.1400.022
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
Rate of chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
pregnancy blood test
Secondary outcomes
1
Description
Rate of clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Seeing gestational sac in sonography
2
Description
Rate of chemical abortion
Timepoint
4 weeks after embryo transfer
Method of measurement
Positive pregnancy blood test without gestational sac
Intervention groups
1
Description
Control group: This group just receive 6 mg of Estradiol valerate daily from the second day of the menstrual cycle. Transvaginal sonography is performed on day 13 of the menstrual cycle, and after reaching an endometrial thickness of at least 7 mm, 400 mg of vaginal Progesterone twice daily with 6 mg of estradiol daily for three days until the day of embryo transfer will consume.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in the case group will receive a monthly dose of Triptorelin 3.75 for up to two months plus 5 mg of Letrozole daily, and immediately after the end of two months of treatment they will enter the freeze embryo transfer cycle and start taking 6 mg of estradiol daily. Transvaginal sonography is performed on day 13 of the menstrual cycle, and after reaching an endometrial thickness of at least 7 mm, 400 mg of vaginal Progesterone twice daily with 6 mg of estradiol daily for three days until the day of embryo transfer will consume.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Behnaz Gandom
Street address
Bouali ave, Safaeiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
behnaz.gandom@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Houshang Mehrparvar
Street address
Bahonar Square, Central Building of Yazd Shahid Sadoughi University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Web page address
http://ssu.ac.ir/cms
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Razieh Dehghani Firoozabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
Firouzabadirazieh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Razieh Dehghani Firoozabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
Firouzabadirazieh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sara Naghibzadeh Sharbabaki
Position
Pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
sara_naghib848@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All participant data sets are to be shared.
When the data will become available and for how long
2 months after the result publication.
To whom data/document is available
A journal in which the results are published
Under which criteria data/document could be used
Submission of an official application via the agent that is legally in charge
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
yazd-rsi@ssu.ac.ir
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.