Protocol summary
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Study aim
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Assessment and comparison of sperm apoptosis, embryo cytokinetic and pregnancy outcomes of IMSI and ICSI methods in patients with male factor infertility.
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Design
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Patients referred to the Yazd Infertility Center who had male infertility and entered the ART cycles. The cases who had oocytes retrieval on Saturday and Wednesday randomly divided into two groups of control and intervention by computer‐generated random numbers.
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Settings and conduct
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This study was conducted at the Yazd Infertility Center for improving the results of the treatment of male infertile patients who were treated several times and did not respond.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1) Male factor infertility
2) At least 3 years of primary infertility
3) The woman being 38 years or younger
4) An undetected female factor
Exclusion criteria:
Non-ejaculated spermatozoa (TESE,..)and ejaculates below 1million sperm/ml.
The cases that hadn’t good embryos for transfer.
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Intervention groups
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Control group: sperm selection was done at × 400 magnification and then injected into mature oocytes.
Intervention group: sperm selection was done at × 6000 magnification and then injected into mature oocytes.
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Main outcome variables
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Improved sperm and embryo selection methods and pregnancy outcomes in ART cycles
General information
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Reason for update
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Record and update the latest changes applied in the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180130038561N1
Registration date:
2020-07-04, 1399/04/14
Registration timing:
retrospective
Last update:
2021-07-25, 1400/05/03
Update count:
1
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Registration date
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2020-07-04, 1399/04/14
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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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Expected recruitment start date
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2016-04-20, 1395/02/01
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Expected recruitment end date
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2017-05-21, 1396/02/31
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Actual recruitment start date
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2016-05-01, 1395/02/12
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Actual recruitment end date
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2017-08-01, 1396/05/10
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Trial completion date
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2018-05-01, 1397/02/11
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Scientific title
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Assessment and comparison of sperm apoptosis, embryo cytokinetic and pregnancy outcomes of IMSI and ICSI methods in patients with male factor infertility.
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Public title
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Embryo cytokinetic and pregnancy outcome in ICSI and IMSI cycles
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with male factor infertility
At least a history of 3 years primary infertility
Woman had less than 38 years old without any infertility problem
Exclusion criteria:
Azoospermic patients(testicular and epididymal samples)
The cases that hadn’t good embryos for transfer
Total freeze cycles
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Age
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To 38 years old
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Gender
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Both
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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:
95
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The mechanism of randomization was simple and individual randomization. No stratified randomization was used. Randomization was performed using a random number table. The random sequence was consecutive. No allocation concealment was applied.
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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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2015-11-25, 1394/09/04
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Ethics committee reference number
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IR.SSU.MEDICINE.REC.1394.338
Health conditions studied
1
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Description of health condition studied
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Male infertility
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Positive 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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Beta HCG test
Secondary outcomes
1
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Description
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Clinical pregnancy
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Timepoint
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Detection of one or more gestational sac with a fetal heartbeat after 6 weeks
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Method of measurement
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Ultrasound
Intervention groups
1
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Description
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Intervention group: sperm selection was done at x 6000 magnification and then injected into mature oocytes.
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Category
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Treatment - Devices
2
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Description
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Control group: sperm selection was done at x 400 magnification and then injected into mature oocytes.
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Category
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Treatment - Devices
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 University of Medical Sciences
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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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All data can be shared after people have not been identified.
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When the data will become available and for how long
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Starting 6 months after publication
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To whom data/document is available
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The data are only available for people working in academic institutions.
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Under which criteria data/document could be used
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By requesting the Yazd Reproductive Sciences Research Institute, it is possible to teach the relevant technique in medical centers.
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From where data/document is obtainable
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Applicants for documents and data can receive information from Dr. Mangali through the e-mail address es.mangoli@gmail.com or by referring to the Research Institute of Reproductive Sciences of Yazd in the embryology department.
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What processes are involved for a request to access data/document
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Receipt of this data is done by mentioning the reason for using them and also agreeing to use the cooperation of a research institute professor in your study as a guide or clinical consultant.
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Comments
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