The aim of our study is to compare the pregnancy outcomes of cryopreserved embryos transfer in cleavage with blastocyst stage in patients with the history of recurrent implantation failure.
Design
A randomized, not blinded, controlled clinical trial with a parallel group design of 100 patients.
Settings and conduct
This randomized clinical trial will be done at Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, All women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) with embryo cryopreservation and have the history of repeated implantation failure. The patients are divided into group I (blastocyst group) and group II (cleavage group) at the time of disclosing the sealed envelopes by computerized randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women who will be undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with the cryopreserved embryo.
Exclusion criteria: women with the history of sever endometriosis; endocrine disorders; or hysteroscopic surgery
Intervention groups
Intervention: Transfer of frozen embryo after culture in the medium in blastocyst stage.
Control: Transfer of frozen embryo in the cleavage stage.
Main outcome variables
chemical pregnancy; clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006420N16
Registration date:2018-07-30, 1397/05/08
Registration timing:registered_while_recruiting
Last update:2018-07-30, 1397/05/08
Update count:1
Registration date
2018-07-30, 1397/05/08
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The pregnancy outcome after blastocyst transfer in women with the history of repeated implantation failure in frozen-thawed cycles
Public title
Blastocyste transfer in patients with history of repeated implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women use frozen embryo transfer
History of repeated implantation failure
Exclusion criteria:
History of severe endometriosis
History of severe male factor infertility
History of endocrine disorder
History of hysteroscopic surgery
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
using computer-generated random numbers in wrapped,
unlabeled envelope each holding a unique number
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 Infertility Research Center
Street address
Bouali avenue , Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.SSU.RSI.REC.1396.9
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
15 days after embryo transfer
Method of measurement
Blood laboratory kit
2
Description
Clinical pregnancy
Timepoint
3 weeks after positive beta-h Cg
Method of measurement
Observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
1
Description
Miscarriage rate
Timepoint
Loss of pregnancy before 20 gestational week
Method of measurement
Absence of fetal heart activity in ultra sound sonography
Intervention groups
1
Description
Intervention group: Thawing will be done at least 2 months after cryopreservation. All embryos in group 1 (blastocyst group) transfer to media and extended culturewill be done for 3 days until blastocyst development. Endometrial preparation will be done by estradiol valerate (Aburaihan,Iran) consumption orally at the dose of 6 mg per day from the second day of the menstrual cycle. In day13 of the cycle, an ultrasound examination will be perform. When the endometrial thickness reaches more than 8 mm in diameter, 400 mg vaginal progesterone(Aburaihan,Iran) will be used 2 times daily. Transfer of embryos will be done done 3 days after thawing and thawing will be done 2 days after progesterone injection. Estradiol and progesterone consumption will be continued until the documentation of fetal heart activity by ultrasound.
Category
Treatment - Other
2
Description
Control group: Thawing will be done at least 2 months after cryopreservation. All embryos in group 2 (cleavage group) are transferred to the uterine cavity 2 hours after thawing. Endometrial preparation will be done by estradiol valerate(Aburaihan,Iran) consumption orally at the dose of 6 mg per day from the second day of the menstrual cycle. In day13 of the cycle, an ultrasound examination will be performed. When the endometrial thickness reaches more than 8 mm in diameter, 400 mg progesterone(Aburaihan,Iran) vaginally will be used 2 times in a day. Thawing will be done 2 days after progesterone injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Street address
Bouali avenue , Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Email
eftekharmaryam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
abass aflatounian
Street address
Bouali avenue , Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
Eftekhar@ssu.ac.ir
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
maryam eftekhar
Position
assocuated professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali avenue ,Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
maryam eftekhar
Position
associated professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali avenue ,Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekhar@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
maryam eftekhar
Position
associated professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali avenue ,Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of patients
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
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
The study protocol, the statistical analysis map, the clinical study report will be available after publishing of the article.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
use in the retrospective study
From where data/document is obtainable
Yazd research and clinical center for infertility
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, request is referred to the research experts and then get the data.