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Trial registered on ANZCTR
Registration number
ACTRN12613000954729
Ethics application status
Approved
Date submitted
23/08/2013
Date registered
28/08/2013
Date last updated
10/03/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of embryonic growth following intracytoplasmic sperm injection (ICSI) between two hyaluronan binding based sperm selection methods - physiological intracytoplasmic sperm injection (PICSI) dish vs liquid hyaluronan
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Scientific title
Morphokinetic analysis of embryos resulting from two hyaluronan binding-based sperm selection methods (physiological intracytoplasmic sperm injection (PICSI) dish vs liquid hyaluronan) - a sibling oocyte study
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Secondary ID [1]
283057
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infertility
289897
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Condition category
Condition code
Reproductive Health and Childbirth
290261
290261
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0
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Fertility including in vitro fertilisation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
PICSI dish and Spermslow media are both designed for sperm selection prior to intracytoplasmic sperm injection (ICSI). They are both based on the hyaluronan-sperm binding assay but with different protocols. The former is coated with solid hyaluronan while the latter is the liquid status hyaluronan. Mature sperm tend to lose its progrssive motility when meet hyaluronan while immature ones don't. Sibling oocytes collected from each participating patient will be randomly allocated into the PICSI (control) and Spermslow (treatment) groups. Prepared sperm sample will be split and then undergo either selection methods (control or treatment group) prior to ICSI. Selected sperm from each group will be used for ICSI with sibling oocytes. After injection, comparisons will be made on ferilisation rate, time post ICSI insemination to reach syngamy, 2,3,4,5,6,7,8-cell stages (t2,t3,t4,t5,t6,t7,t8)(hours), and implantation results after transfer of embryos. Only one-off intervention is involved at the sperm/egg level, none at the patient level.
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Intervention code [1]
287779
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Treatment: Devices
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Comparator / control treatment
PICSI dish and Spermslow media are both designed for sperm selection prior to intracytoplasmic sperm injection (ICSI). They are both based on the hyaluronan-sperm binding assay but with different protocols. The former is coated with solid hyaluronan while the latter is the liquid status hyaluronan. Mature sperm tend to lose its progrssive motility when meet hyaluronan while immature ones don't. Sibling oocytes collected from each participating patient will be randomly allocated into the PICSI (control) and Spermslow (treatment) groups. Prepared sperm sample will be split and then undergo either selection methods (control or treatment group) prior to ICSI. Selected sperm from each group will be used for ICSI with sibling oocytes. After injection, comparisons will be made on ferilisation rate, time post ICSI insemination to reach syngamy, 2,3,4,5,6,7,8-cell stages (t2,t3,t4,t5,t6,t7,t8)(hours), and implantation results after transfer of embryos. Only one-off intervention is involved at the sperm/egg level, none at the patient level.
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Control group
Active
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Outcomes
Primary outcome [1]
290287
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Fertilisation rate(%)
Calculated as (number of oocyte normally fertilised)/(number of oocyte inseminated)x100%
Normal fertilisation is confirmed by appearance of 2 pronuclei observed on Embryoscope
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Assessment method [1]
290287
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Timepoint [1]
290287
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24 hrs
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Primary outcome [2]
290288
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Time post ICSI insemination to reach syngamy, 2,3,4,5,6,7,8-cell stages (t2,t3,t4,t5,t6,t7,t8)(hours)
Embryoscope is a time-lapse photographing incubator providing accurate timings for biological events during embryo development. Timings for syngamy and t2,t3,t4,t5,t6,t7,t8 of embryos cultured in the Embryoscope will be automatically recorded .
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Assessment method [2]
290288
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Timepoint [2]
290288
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72 hrs
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Primary outcome [3]
290325
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Synchronity of cleavage: s2 and s3 (hours)
S2=t4-t3
S3=t8-t5
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Assessment method [3]
290325
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Timepoint [3]
290325
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72 hrs
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Secondary outcome [1]
304244
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Embryo implantation rate (%) after transfer
Implantation is confirmed by detection of fetal heart beat under ultrasound 5 weeks after oocyte pick-up.
Implantation rate (%) = (number of fetal heart beat detected)/(number of embryo transferred) x 100%
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Assessment method [1]
304244
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Timepoint [1]
304244
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5 weeks
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Eligibility
Key inclusion criteria
All patients who meet the PICSI treatment criteria according to Fertility North protocols, including high sperm DNA fragmentation or poor result in previous ICSI treatment.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Poor semen quality (motile sperm count less than 1 million) or
poor ovarian response (less than 2 oocytes collected)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
Data collected will udergo t-tests. so the number of participants was calculated via an on-line sample size calculator.
http://www.statstodo.com/SSiz2Means_Pgm.php
Fixed setting: Probability of Type I Error (a) = 0.05 &
Power (1 - B) = 0.8.
Regarding the (Difference to be detected) and (Within group SD), different values were used for different parameters. The final sample size (n=180 for each group) was determined by the biggest sample size required for any parameters to be assessed.
The average egg number collected per patient at Fertility North is 6, so the estimated number of participants is 60.
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
1/11/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
287821
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Commercial sector/Industry
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Name [1]
287821
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Fertility North
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Address [1]
287821
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Suite 213, Specialist Medical Centre
Joondalup Health Campus
Shenton Ave
Joondalup WA 6027
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Country [1]
287821
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Fertility North
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Address
Suite 213, Specialist Medical Centre
Joondalup Health Campus
Shenton Ave
Joondalup WA 6027
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Country
Australia
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Secondary sponsor category [1]
286551
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University
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Name [1]
286551
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Edith Cowan University
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Address [1]
286551
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270 Joondalup Drive,
Joondalup WA 6027
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Country [1]
286551
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289768
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Joondalup Health Campus Human Research Ethics Committee
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Ethics committee address [1]
289768
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Joondalup Health Campus,
Shenton Ave,
Joondalup, WA 6027
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Ethics committee country [1]
289768
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Australia
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Date submitted for ethics approval [1]
289768
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02/09/2013
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Approval date [1]
289768
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20/09/2013
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Ethics approval number [1]
289768
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1319
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Summary
Brief summary
PICSI dish and Spermslow (liquid hyaluronan) are both hyaluronan binding-based sperm selection methods. Publications have shown benefits of sperm selection by either method before intracytoplasmic sperm injection. However few study has compared the efficacy between these two methods. The proposed study will compare sibling embryos resulted from these two methods by using time-lapse analysis.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
42322
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Mr Yanhe Liu
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Address
42322
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Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
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Country
42322
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Australia
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Phone
42322
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+61 8 9301 1075
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Fax
42322
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Email
42322
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[email protected]
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Contact person for public queries
Name
42323
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Dr Phill Matson
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Address
42323
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Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
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Country
42323
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Australia
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Phone
42323
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+61 8 9301 1075
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Fax
42323
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Email
42323
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[email protected]
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Contact person for scientific queries
Name
42324
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Dr Phill Matson
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Address
42324
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Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
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Country
42324
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Australia
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Phone
42324
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+61 8 9301 1075
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Fax
42324
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Email
42324
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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