Protocol summary
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Study aim
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Comparison of clinical outcomes between Natural Sperm Sorting and Direct Swim Up in ICSI program in the donation casee
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Design
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Clinical trial was performed with parallel control and intervention groups, study on 50 infertile couples who donated oocyte
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Settings and conduct
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Among the patients who refer to Yazd Infertility Center, 50 samples of normal semen are randomly selected. Female infertility and candidate egg donation were the main diagnostic factors for all couples, and all patients received written consent to participate in the study protocol.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria : the female feature patient that needs oocyte donation and normal sperm and donor female feature as follows: donor age<30 with having at least 5 metaphase II oocyte
The exclusion criteria : surgical sperm retrieval; female donor age>30, frozen donor eggs; cancelled cycles and cycles with missing key data
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Intervention groups
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Each person's sperm sample is divided into two parts:
Interventional group: they are prepared in a method without using a centrifuge.
Control group: No intervention is made.
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Main outcome variables
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Chemical pregnancy rate and clinical pregnancy rate
General information
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Reason for update
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Update sampling date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201104049263N1
Registration date:
2021-09-13, 1400/06/22
Registration timing:
prospective
Last update:
2022-03-04, 1400/12/13
Update count:
2
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Registration date
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2021-09-13, 1400/06/22
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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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2021-09-16, 1400/06/25
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Expected recruitment end date
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2022-03-11, 1400/12/20
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Actual recruitment start date
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2021-09-16, 1400/06/25
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Actual recruitment end date
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2021-12-22, 1400/10/01
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Trial completion date
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2022-01-30, 1400/11/10
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Scientific title
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Comparison of clinical outcomes between Natural Sperm Sorting (NSS) and Direct Swim Up (DSU) in ICSI program; Assessments of mitocondorial, chromatin integrity and fine morphology (MSOME)
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Public title
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Evaluation of the effect of sperm preparation by free centrifugation on clinical outcomes in ICSI cycles
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Non male factor
Female with donation cases for homogenization Study groups
Exclusion criteria:
Male factor
Female factor
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Age
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From 20 years old to 40 years old
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Gender
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Both
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Phase
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4
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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:
50
More than 1 sample in each individual
Number of samples in each individual:
2
Each sample is divided into two parts for DSU separation and the other for NSS separation.
Actual sample size reached:
60
More than 1 sample in each individual
Actual sample size in each individual:
2
Each mixed semen sample was split into two equal portions, with the first being processed using the DSU technique (control) and the second using the FCS method (experimental)
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Randomization (investigator's opinion)
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N/A
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Randomization description
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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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2021-01-06, 1399/10/17
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Ethics committee reference number
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IR.SSU.MEDICINE.REC.1399.259
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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N97
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ICD-10 code description
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Female infertility
Primary outcomes
1
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Description
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Fertilization rate
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Timepoint
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One day after assisted artificial insemination
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Method of measurement
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Microscopic examination
2
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Description
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Embryo formation rate
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Timepoint
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3 days after assisting artificial insemination
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Method of measurement
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Microscopic evaluation
3
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Description
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Chemical pregnancy rate
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Timepoint
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One week after the embryo transfer to the uterus
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Method of measurement
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Blood βHCG Measurement
Secondary outcomes
1
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Description
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Clinical pregnancy rate
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Timepoint
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7 weeks after embryo transfer to the uterus
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Method of measurement
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Assessment of cardiovascular formation using ultrasound examination
Intervention groups
1
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Description
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Control group: sorted sperm with Direct swim up.
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Category
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Treatment - Other
2
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Description
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Intervention group: Sperms that are isolated by NSS method.
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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 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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Undecided - It is not yet known if there will be 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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Data: 1) Fertility rate, by examining the formation of proonucleus in the egg cell
2) Checking the embryo quality and calculating the time related to the process of cell division of the embryo
3) Checking the chemical and clinical pregnancy rates respectively one week and 7 weeks after embryo transfer
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When the data will become available and for how long
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Up to one year after publication of the article
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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With the re-consent of the participant and the researcher responsible of the projec
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From where data/document is obtainable
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Mohammad Ali Khalili 09133570876
khalili59@hotmail.com
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What processes are involved for a request to access data/document
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mohammad ali khalili 09133570876 khalili59@hotmail.com
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Comments
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