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Evaluation of pregnancy outcome after Transfer of Blastocysts derived from Frozen –Thawed cleavage stage embryos

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History
# Registration date Revision Id
3 2021-03-16, 1399/12/26 177036
2 2021-03-04, 1399/12/14 173775
1 2011-09-01, 1390/06/10 6865
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  • General information

    128
    150
    2011-06-30, 1390/04/09
    2010-12-30, 1389/10/09
    2011-06-30, 1390/04/09
    2010-12-30, 1389/10/09
    2011-09-30, 1390/07/08
    2011-06-30, 1390/04/09
    ناني كه تحت درمان ناباروري با روش آي. وي. اف يا ميكرواينجكشن قرار گرفته و جنين فريز شده دارند.
    زناني كه تحت درمان ناباروري با روش آي. وي. اف يا ميكرواينجكشن قرار گرفته و جنين فريز شده دارند.
    history of diabetes mellitus
    thyroid disease
    severe endometriosis
    Oocyte donation cycles
    Women with age>35 years
    body mass index (BMI)>30 kg/m2
    History of diabetes mellitus
    Thyroid disease
    Severe endometriosis
    Oocyte donation cycles
    Women with age>35 years
    Body mass index (BMI)>30 kg/m2
    The patients were divided into group I (blastocyst group) and group II (cleavage group) at the time of disclosing the sealed envelopes by computerized randomization.
    In this trial, 135 infertile women who were candidate for IVF or ICSI were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table.
    بیماران با استفاده از تصادفی سازی کامپیوتری به دو گروه بلاستوسیت و کلیواژ تقسیم شدند.
    در این مطالعه 134 زن کاندید IVF و یا ICSI پس از توجیه شدن در مورد شرایط مطالعه و اخذ رضایت آگاهانه وارد مطاله شدند. تمام بیماران به صورت تصادفی به دو گروه تقسیم شدند. تصادفی سازی به صورت ساده، فردی و با استفاده از جدول اعداد تصادفی انجام شد.

  • Primary outcomes

    #1
    chemical pregnancy
    Chemical pregnancy
    blood laboartory kit
    Blood laboartory kit
    #2
    observation of fetal heart activity by transvaginal ultrasonography
    Observation of fetal heart activity by transvaginal ultrasonography
    #3
    ultrasonography
    Ultrasonography

  • Secondary outcomes

    #1
    lost of pregnancy before 20 gestational week
    Lost of pregnancy before 20 gestational week
    absence of fetal heart activity in ultra sound sonography
    Absence of fetal heart activity in ultra sound sonography

Protocol summary

Study aim
The aim of this study was to compare implantation and pregnancy rates from vitrified-thawed cleavage-stage embryos which were cultured further to the blastocyst stage versus vitrified-thawed cleavage-stage embryos
Design
134 women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) with embryo cryopreservation in a randomized clinical trial without a control group, parallel trial without blindness, phase 2 were randomly divided into two groups.
Settings and conduct
134 women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation in Yazd Reserch and Clinical center for Infertilty. The patients were randomly divided into group I (blastocyst group) and group II (cleavage group).
Participants/Inclusion and exclusion criteria
All women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation. Women with age>35 years, body mass index (BMI)>30 kg/m2, history of diabetes mellitus, thyroid diseaseand severe endometriosis were excluded from the study. Oocyte donation cycles were excluded from the study as well.
Intervention groups
group I: embryos were transferred in the blastocyst stage group II: embryos were transferred in the cleavage stage
Main outcome variables
Chemical, Clinical and ongoing pregnancy rates

General information

Reason for update
Updating the trial according to the last changes in methods and adding results
Acronym
IRCT registration information
IRCT registration number: IRCT201107306420N7
Registration date: 2011-09-01, 1390/06/10
Registration timing: retrospective

Last update: 2021-04-03, 1400/01/14
Update count: 2
Registration date
2011-09-01, 1390/06/10
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
Yazd research and clinical center for infertility
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2010-12-30, 1389/10/09
Actual recruitment start date
2009-01-01, 1387/10/12
Actual recruitment end date
2010-12-30, 1389/10/09
Trial completion date
2011-06-30, 1390/04/09
Scientific title
Evaluation of pregnancy outcome after Transfer of Blastocysts derived from Frozen –Thawed cleavage stage embryos
Public title
Transfer of Blastocysts in cryopreseved cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women underwent previously in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation
Exclusion criteria:
History of diabetes mellitus Thyroid disease Severe endometriosis Oocyte donation cycles Women with age>35 years Body mass index (BMI)>30 kg/m2
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Actual sample size reached: 134
Randomization (investigator's opinion)
Randomized
Randomization description
In this trial, 135 infertile women who were candidate for IVF or ICSI were informed about the research design and signed a written consent form. All women were randomly divided into two groups. Randomization was simple, individual using a random number table.
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
Yazd Research and Clinical Center for Infertility, Yazd University of Medical Sciences
Street address
Safaeieh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2011-06-19, 1390/03/29
Ethics committee reference number
927

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified

Primary outcomes

1

Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Blood laboartory kit

2

Description
clinical pregnancy
Timepoint
5 weeks after positive beta-hCG
Method of measurement
Observation of fetal heart activity by transvaginal ultrasonography

3

Description
Ongoing pregnancy
Timepoint
12 weeks after embryo transfer
Method of measurement
Ultrasonography

Secondary outcomes

1

Description
Miscarriage rate
Timepoint
Lost of pregnancy before 20 gestational week
Method of measurement
Absence of fetal heart activity in ultra sound sonography

Intervention groups

1

Description
Intervention: Thawing is done at least 2 months after cryopreservation. All embryos in group 1 (blastocyst group) transfer to media and extended culture is done for 3 days until blastocyst development. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Transfer of embryos is done 3 days after thawing and thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound .
Category
Treatment - Other

2

Description
Control: Thawing is done at least 2 months after cryopreservation. All embryos in group 2 (cleavage group) are transfered to uterine cavity 2 hours after thawing. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Thawing is done 2 days after progestron 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 ave
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr.Abbas Aflatoonian
Street address
Bouali avenue , Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatoonian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd research and clinical center for infertility
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
YAazd Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Position
Gynecologist,MD
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 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Gynecologist,MD
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 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
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 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

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
Yes - There is 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 incharge
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085 eftekharmaryam@yahoo.com
What processes are involved for a request to access data/document
2 months after application
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