Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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).
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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group I: embryos were transferred in the blastocyst stage
group II: embryos were transferred in the cleavage stage
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Main outcome variables
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Chemical, Clinical and ongoing pregnancy rates
General information
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Reason for update
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Updating the trial according to the last changes in methods and adding results
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Acronym
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IRCT registration information
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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
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Registration date
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2011-09-01, 1390/06/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Yazd research and clinical center for infertility
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Expected recruitment start date
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2009-01-01, 1387/10/12
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Expected recruitment end date
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2010-12-30, 1389/10/09
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Actual recruitment start date
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2009-01-01, 1387/10/12
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Actual recruitment end date
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2010-12-30, 1389/10/09
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Trial completion date
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2011-06-30, 1390/04/09
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Scientific title
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Evaluation of pregnancy outcome after Transfer of Blastocysts derived from Frozen –Thawed cleavage stage embryos
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Public title
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Transfer of Blastocysts in cryopreseved cycles
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
150
Actual sample size reached:
134
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2011-06-19, 1390/03/29
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Ethics committee reference number
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927
Health conditions studied
1
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Description of health condition studied
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Infertility
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ICD-10 code
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N98.9
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ICD-10 code description
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Complication associated with artificial fertilization, unspecified
Primary outcomes
1
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Description
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Chemical pregnancy
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Timepoint
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14 days after embryo transfer
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Method of measurement
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Blood laboartory kit
2
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Description
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clinical pregnancy
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Timepoint
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5 weeks after positive beta-hCG
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Method of measurement
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Observation of fetal heart activity by transvaginal ultrasonography
3
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Description
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Ongoing pregnancy
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Timepoint
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12 weeks after embryo transfer
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Method of measurement
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Ultrasonography
Secondary outcomes
1
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Description
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Miscarriage rate
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Timepoint
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Lost of pregnancy before 20 gestational week
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Method of measurement
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Absence of fetal heart activity in ultra sound sonography
Intervention groups
1
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Description
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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 .
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd research and clinical center for infertility
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participant data sets are to be shared
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When the data will become available and for how long
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2 months after the result publication
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To whom data/document is available
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A journal in which the results are published
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Under which criteria data/document could be used
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Submission of an official application via the agent that is legally incharge
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From where data/document is obtainable
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Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran.
983538247085
eftekharmaryam@yahoo.com
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What processes are involved for a request to access data/document
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2 months after application
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Comments
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