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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
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
Secondary ID [1] 283057 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 289897 0
Condition category
Condition code
Reproductive Health and Childbirth 290261 290261 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287779 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 290287 0
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
Timepoint [1] 290287 0
24 hrs
Primary outcome [2] 290288 0
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 .
Timepoint [2] 290288 0
72 hrs
Primary outcome [3] 290325 0
Synchronity of cleavage: s2 and s3 (hours)

S2=t4-t3
S3=t8-t5
Timepoint [3] 290325 0
72 hrs
Secondary outcome [1] 304244 0
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%
Timepoint [1] 304244 0
5 weeks

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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor semen quality (motile sperm count less than 1 million) or
poor ovarian response (less than 2 oocytes collected)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
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.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/11/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287821 0
Commercial sector/Industry
Name [1] 287821 0
Fertility North
Country [1] 287821 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fertility North
Address
Suite 213, Specialist Medical Centre
Joondalup Health Campus
Shenton Ave
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 286551 0
University
Name [1] 286551 0
Edith Cowan University
Address [1] 286551 0
270 Joondalup Drive,
Joondalup WA 6027
Country [1] 286551 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289768 0
Joondalup Health Campus Human Research Ethics Committee
Ethics committee address [1] 289768 0
Ethics committee country [1] 289768 0
Australia
Date submitted for ethics approval [1] 289768 0
02/09/2013
Approval date [1] 289768 0
20/09/2013
Ethics approval number [1] 289768 0
1319

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42322 0
Mr Yanhe Liu
Address 42322 0
Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
Country 42322 0
Australia
Phone 42322 0
+61 8 9301 1075
Fax 42322 0
Email 42322 0
yanhe@fertilitynorth.com.au
Contact person for public queries
Name 42323 0
Phill Matson
Address 42323 0
Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
Country 42323 0
Australia
Phone 42323 0
+61 8 9301 1075
Fax 42323 0
Email 42323 0
phill.matson@fertilitynorth.com.au
Contact person for scientific queries
Name 42324 0
Phill Matson
Address 42324 0
Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
Country 42324 0
Australia
Phone 42324 0
+61 8 9301 1075
Fax 42324 0
Email 42324 0
phill.matson@fertilitynorth.com.au

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.