Protocol summary
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Study aim
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Determination of embryocytokinetic and outcomes of intracytoplasmic sperm injection using sperms bound to the zona pellucida of immature oocytes
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Design
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This study is designed as a clinical trials with parallel control and intervention groups. Sperms are derived from main sperm sample that gathered from male patient. Blindness has not been performed and study has been performed on 50 infertile couples.
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Settings and conduct
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location of this research is the Research and Clinical Center for Infertility, faculty of medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: less than 40 years old; at least six MII oocytes and one meta phase I oocyte retrieved; Semen samples with sperm concentration more than 5 million motile spermatozoa/ml.
Non-inclusion criteria: Non ejaculated spermatozoa (testicular or epididymal sperm retrieval).
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Intervention groups
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Each patient's oocyte are divided into control and target groups
Intervention group 1: intracytoplasmic sperm injection usingsperm bound to the zona pellucida of immature oocytes
control group :conventional intracytoplasmic sperm injection
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Main outcome variables
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Rate of implantation; Clinical pregnancy rate
General information
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Reason for update
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1- The reason for changing the start time of the study was that we had to start work after the production of IRCT approval.
2- Remove of one of the secondary outcome named integration of embryo zona pellucida was that the embryos would not be out of the incubator for longer than necessary.
3- Primary and secondary outcomes updated.
4-The target sample size was updated (after statistical study, the decision was made to change).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200705048021N1
Registration date:
2020-09-01, 1399/06/11
Registration timing:
prospective
Last update:
2022-04-18, 1401/01/29
Update count:
1
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Registration date
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2020-09-01, 1399/06/11
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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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2021-02-26, 1399/12/08
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Expected recruitment end date
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2022-02-28, 1400/12/09
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Actual recruitment start date
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2020-10-28, 1399/08/07
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Actual recruitment end date
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2022-01-05, 1400/10/15
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Trial completion date
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2022-04-23, 1401/02/03
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Scientific title
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Comparison of the effects of sperm selection using sperm bounded to zona pellusida of immature oocyte and sperm selection by current methods on embryo morphokinitic and clinical fertility outcomes in infertile couples
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Public title
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Effects of sperm selection by zona pellucida binding method on fertility outcomes and embryo morphokinitics
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age less than 40 years old
At least six MII oocytes and one metaphase I oocyte retrieved
Spouse semen samples with sperm concentration more than 5*106 motile spermatozoa
Exclusion criteria:
Non ejaculated spermatozoa (testicular or epididymal sperm retrieval) (for example: Azoospermia and cryptoazoospermia)
cases in which the sperm cells were not bound to the zona pellucida for any reason
Women with polycystic ovary syndrome
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Age
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To 40 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:
70
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple random allocation is used for randomization. In this way, one of the two completely identical balls with numbers 1 or 2 in a lottery container is randomly selected and then with the arrival of ball 1, the sample is allocated to the control group and the ball 2 is allocated to the intervention group.
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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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2019-09-15, 1398/06/24
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Ethics committee reference number
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IR.SSU.RSI.REC.1398.022
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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N46
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ICD-10 code description
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Male infertility
Primary outcomes
1
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Description
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Rate of clinical pregnancy
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Timepoint
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Rate of clinical pregnancy is evaluated 6 weeks after assisted reproductive technique.
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Method of measurement
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Clinical pregnancy is measured through the recording of heart beat by ultrasonography.
Secondary outcomes
1
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Description
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Fertilization rate
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Timepoint
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Sixteen to 20 hours after performing of assisted reproductive technique.
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Method of measurement
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Appearance of pronucleus by binocular loop observation
2
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Description
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Embryo quality
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Timepoint
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Three days after performing of assisted reproductive technique
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Method of measurement
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Total number of normal blastomer and percent of fragmented blastomer in defined time points using Time-Laps system.
3
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Description
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Rate of chemical pregnancy
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Timepoint
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Two weeks after performing of assisted reproductive technique
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Method of measurement
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Measurement of serum Beta-Human Chorionic Gonadotropin
4
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Description
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time lapse parameters
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Timepoint
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After intracytoplasmic injection of sperm (time 0), the following time points are measured: Time of disappearance of pronucleus in zygote (tPNF), Zygote divides into two cells (T2), three cells (T3), four cells (T4), five cells (T5), six cells (T6), seven cells (T7) and eight cells (T8).
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Method of measurement
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Analyzing and measurement using EmbryoViewerTM software
5
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Description
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Rate of implantation
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Timepoint
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The rate of implantation is assessed 1 week to 10 days after the assisted reproduction technique.
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Method of measurement
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Rate of implantation is determined by observation of gestational sac through the vaginal sonography.
Intervention groups
1
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Description
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Intervention group: intracytoplasmic sperm injection using the zonapellucida-bound sperm to immature oocyte.
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Category
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Treatment - Other
2
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Description
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Control group: conventional intracytoplasmic sperm injection
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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 that will be shared with other researchers after removing the identification data of participants:
1- Fertilization rate by examining the formation of proenucleus in the egg cell.
2- Assessment of embryo quality and morphokinetics by the time lapse system and calculating the time related to the process of cell division of the embryo.
3- Chemical and clinical pregnancies one week and seven weeks, respectively, 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 the results
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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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Again with the consent of the participants and the researcher responsible for the project
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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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Send a request via email to the responsible researcher
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Comments
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