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Trial registered on ANZCTR


Registration number
ACTRN12613000957796
Ethics application status
Approved
Date submitted
22/08/2013
Date registered
28/08/2013
Date last updated
10/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of different media for sperm handling and injection at intracytoplasmic sperm injection (ICSI) on subsequent embryo cleavage: a comparison of the use of polyvinylpyrrolidone (PVP) and hyaluronan.
Scientific title
Morphokinetic comparisons of embryos derived from intracytoplasmic sperm injection (ICSI) procedures involving polyvinylpyrrolidone (PVP) or hyaluronan as sperm handling reagent - a randomized sibling oocyte study
Secondary ID [1] 283056 0
Nil
Universal Trial Number (UTN)
U1111-1147-0159
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 289896 0
Condition category
Condition code
Reproductive Health and Childbirth 290260 290260 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sibling oocytes collected from each participating patient will be randomly allocated into the polyvinylpyrrolidone (PVP) (control) and hyaluronan (HA) (treatment) groups. Oocytes will undergo intracytoplasmic sperm injection (ICSI) with different handling medium in each group accordingly. Subsequent embryo culture condition is identical for both groups.
Intervention code [1] 287778 0
Treatment: Other
Comparator / control treatment
This is an auto-controlled sibling oocyte study. One of the 2 equally divided groups will work as the control (PVP) while the other group as treatment group (HA).
Control group
Active

Outcomes
Primary outcome [1] 290285 0
Fertilisation rate(%),
= (number of oocyte normally fertilised)/(number of oocyte inseminated)x100%

Timepoint [1] 290285 0
24 hrs
Primary outcome [2] 290286 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] 290286 0
72 hrs
Primary outcome [3] 290324 0
Synchronity of cleavage: s2 and s3 (hours)

S2=t4-t3 (t3 & t4 are available from primary outcome 2)
S3=t8-t5 (t5 & t8 are available from primary outcome 2)
Timepoint [3] 290324 0
72 hrs
Secondary outcome [1] 304243 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] 304243 0
5 weeks

Eligibility
Key inclusion criteria
All patients having ICSI treatment criteria at Fertility North. Indications for ICSI include low sperm count, low sperm motility, poor sperm morphology or poor fertilisation in previous conventional insemination.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring sperm selection using PICSI dishes, eg male partner with increased incidence of sperm DNA fragmentation.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287820 0
Commercial sector/Industry
Name [1] 287820 0
Fertility North
Address [1] 287820 0
Suite 213, Specialist Medical Centre
Joondalup Health Campus
Shenton Ave
Joondalup WA 6027
Country [1] 287820 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] 286550 0
University
Name [1] 286550 0
Edith Cowan University
Address [1] 286550 0
270 Joondalup Drive,
Joondalup WA 6027
Country [1] 286550 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289767 0
Joondalup Health Campus Human Research Ethics Committee
Ethics committee address [1] 289767 0
Joondalup Health Campus,
Shenton Ave,
Joondalup, WA 6027
Ethics committee country [1] 289767 0
Australia
Date submitted for ethics approval [1] 289767 0
02/09/2013
Approval date [1] 289767 0
20/09/2013
Ethics approval number [1] 289767 0
1319

Summary
Brief summary
Polyvinylpyrrolidone (PVP) has been routinely used in the intracytoplasmic sperm injection procedures to facilitate sperm handling for years although it's not degradable by the egg. Hyaluronan is a new alternative to PVP with all the features that PVP has and it's degradable by the egg. The proposed study aims at comparing the embryonic effect between these 2 reagents by using time-lapse analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42318 0
Mr Yanhe Liu
Address 42318 0
Fertility North
Suite 213, Specialist Medical Centre,
Joondalup Health Campus,
Shenton Ave,
Joondalup WA 6027
Country 42318 0
Australia
Phone 42318 0
+61 8 9301 1075
Fax 42318 0
Email 42318 0
yanhe@fertilitynorth.com.au
Contact person for public queries
Name 42319 0
Dr Phill Matson
Address 42319 0
Fertility North
Suite 213, Specialist Medical Centre,
Joondalup Health Campus,
Shenton Ave,
Joondalup WA 6027
Country 42319 0
Australia
Phone 42319 0
+61 8 9301 1075
Fax 42319 0
Email 42319 0
phill.matson@fertilitynorth.com.au
Contact person for scientific queries
Name 42320 0
Dr Phill Matson
Address 42320 0
Fertility North
Suite 213, Specialist Medical Centre,
Joondalup Health Campus,
Shenton Ave,
Joondalup WA 6027
Country 42320 0
Australia
Phone 42320 0
+61 8 9301 1075
Fax 42320 0
Email 42320 0
phill.matson@fertilitynorth.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary