Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001065280
Ethics application status
Not yet submitted
Date submitted
22/07/2009
Date registered
11/12/2009
Date last updated
11/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Picking Intracytoplasmic Sperm Injection (PICSI) improve clinical pregnancy rates in men with elevated deoxyribonucleic acid fragmentation index(DFI) undertaking intracytoplasmic sperm injection (ICSI )treatment for infertility? A randomised pilot study.
Scientific title
Does Picking Intracytoplasmic Sperm Injection (PICSI) improve clinical pregnancy rates in men with elevated deoxyribonucleic acid fragmentation index (DFI) undertaking intracytoplasmic sperm injection (ICSI) treatment for infertility? A randomised pilot study.
Secondary ID [1] 1192 0
none
Universal Trial Number (UTN)
Trial acronym
PICSI vs ICSI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male infertility - high deoxyribonucleic acid (DNA) fragmentation index (DFI) 237334 0
Condition category
Condition code
Reproductive Health and Childbirth 239657 239657 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PICSI - a type of fertilisation technique which allows mature sperm to bind to a substance (hyaluronan) in a dish. Scientists then pick a sperm for use in ICSI from this select population of sperm. Selection is based on morphology and motility.
This intervention process takes 5-10 minutes.
Intervention code [1] 236997 0
Treatment: Devices
Comparator / control treatment
ICSI - routine injection of sperm into an egg with scientist picking the best sperm based on appearance of sperm. The duration of this procedure is 2-3 minutes per egg injected.
Control group
Active

Outcomes
Primary outcome [1] 238432 0
Fertilization rates- the scientists check for fertilisation 24 hrs after the sperm is injected. They do this by looking under a microscope .
Timepoint [1] 238432 0
1 year following randomization
Secondary outcome [1] 244933 0
Pregnancy rates. A pregnancy hormone test is carried out 14 days after the embryo is transferred into the uterus and if this is positive, an ultrasound of the uterus is performed 6 weeks later to confirm an intrauterine pregnancy.
Timepoint [1] 244933 0
1yr following randomisation

Eligibility
Key inclusion criteria
All couples eligible for (intracytoplasmic sperm injection) ICSI
Minimum age
No limit
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men not eligible for Pick Intracytoplasmic Sperm Injection (PICSI)
Where the women is older than 43 years of age

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects will be invited to participate in the trial if they require ICSI.
On the day of sperm collection for (in vitro fertilzation) IVF, a Sperm Chromatin Structure Assay (SCSA ) test will be performed on all men and they will be randomly allocated to either PICSI or ICSI
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomization will be used using sealed opaque envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237382 0
Hospital
Name [1] 237382 0
Royal Prince Alfred Hospital Fertility Unit (RPAH )
Country [1] 237382 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sydney IVF
Address
321 Kent St
Sydney NSW
2000
Country
Australia
Secondary sponsor category [1] 236882 0
Hospital
Name [1] 236882 0
RPAH
Address [1] 236882 0
Royal Prince ALfred Hospital (RPAH) Fertility Unit
Missenden rd
Camperdown
NSW 2050
Country [1] 236882 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239514 0
Sydney South West Area Health Service
Ethics committee address [1] 239514 0
Royal Prince Alfred Hospital (RPAH)
Missenden Rd
Camperdown
2050
NSW
Ethics committee country [1] 239514 0
Australia
Date submitted for ethics approval [1] 239514 0
09/12/2009
Approval date [1] 239514 0
Ethics approval number [1] 239514 0

Summary
Brief summary
Intracytoplasmic sperm injection is commonly used to aid fertilisation rates in men with low sperm counts , poor sperm mobility and high levels of sperm DNA fragmentation. The sperm used to inject into the egg is hand picked by the scientist, based on sperm appearance. However, a scientist is unable to detect poor DNA based on sperm appearance. The PICSI dish contains a substance called hyaluronan that normally exists around an egg. It is proposed that sperm with lower levels of DNA damage are more likely to bind to this hyaluronan. This allows the scientists to be more selective in the handpicking process. By handpicking only that sperm that has bound to the substance, they may be selecting the better sperm for injection into the egg.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29950 0
Address 29950 0
Country 29950 0
Phone 29950 0
Fax 29950 0
Email 29950 0
Contact person for public queries
Name 13197 0
natasha andreadis
Address 13197 0
RPAH FERTILITY UNIT
Missenden Rd
Camperdown
2050
nsw
Country 13197 0
Australia
Phone 13197 0
+61 2 9515 6111
Fax 13197 0
+61 2 9515 7976
Email 13197 0
[email protected]
Contact person for scientific queries
Name 4125 0
natasha andreadis
Address 4125 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown
NSW 2050
Country 4125 0
Australia
Phone 4125 0
+61 2 9515 6111
Fax 4125 0
+61 2 9515 7976
Email 4125 0
[email protected]

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.