Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000953730
Ethics application status
Approved
Date submitted
23/08/2013
Date registered
27/08/2013
Date last updated
10/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the performance of two sperm preparation methods for conventional in vitro fertilisation (IVF) insemination by assessing subsequent embryo development with time-lapse technology
Scientific title
Morphokinetic analysis of embryos resulting from different sperm preparation methods (Swim-up vs Density gradient centrifugation)- a sibling oocyte study
Secondary ID [1] 283058 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 289898 0
Condition category
Condition code
Reproductive Health and Childbirth 290262 290262 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Swim-up (SU) and Density Gradient centrifugation (DGC) are both routinely used sperm preparation methods during IVF procedure. SU involves layering semen sample and culture media, and active swimming-up of sperm into the media phase so that sperm with good motility can be yielded. However there is a risk that seminal components migrate into the media which is believed to impact fertilisation and subsequent embryo growth. DGC involves centrifugations to force the motile sperm to go through density gradient media and then get separated. But centrifugations are proven to be harmful to sperm integrity and in turn affect fertilisation and subsequent embryo development. DGC is currently used as standard method for sperm preparation at Fertility North and will be used as control group. SU will be the treatment group.

Sibling oocytes collected from each participating patient will be randomly allocated into DGC (control) and SU (treatment) groups. Semen sample provided by the male partner will be split and go through different preparation methods separately. Oocytes in each group will be inseminated with sperm prepared by according method. After insemination, comparisons will be made on ferilisation rate, time post 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] 287780 0
Treatment: Other
Comparator / control treatment
Swim-up (SU) and Density Gradient centrifugation (DGC) are both routinely used sperm preparation methods during IVF procedure. SU involves layering semen sample and culture media, and active swimming-up of sperm into the media phase so that sperm with good motility can be yielded. However there is a risk that seminal components migrate into the media which is believed to impact fertilisation and subsequent embryo growth. DGC involves centrifugations to force the motile sperm to go through density gradient media and then get separated. But centrifugations are proven to be harmful to sperm integrity and in turn affect fertilisation and subsequent embryo development. DGC is currently used as standard method for sperm preparation at Fertility North and will be used as control group. SU will be the treatment group.

Sibling oocytes collected from each participating patient will be randomly allocated into DGC (control) and SU (treatment) groups. Semen sample provided by the male partner will be split and go through different preparation methods separately. Oocytes in each group will be inseminated with sperm prepared by according method. After insemination, comparisons will be made on ferilisation rate, time post 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] 290289 0
Fertilisation rate(%),
= (number of oocyte normally fertilised)/(number of oocyte inseminated)x100%
Timepoint [1] 290289 0
24 hrs
Primary outcome [2] 290290 0
Time post 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] 290290 0
72 hrs
Primary outcome [3] 290331 0
Synchronity of cleavage: s2 and s3 (hours)

S2=t4-t3
S3=t8-t5
Timepoint [3] 290331 0
72 hrs
Secondary outcome [1] 304245 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] 304245 0
5 weeks

Eligibility
Key inclusion criteria
All patients who meet the IVF treatment criteria according to Fertility North protocols, including tubal factor, PCOS, low AMH or multiple failures in previous IUI treatment.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Semen quality of partner not within normal range

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] 287822 0
Commercial sector/Industry
Name [1] 287822 0
Fertility North
Country [1] 287822 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] 286552 0
University
Name [1] 286552 0
Edith Cowan University
Address [1] 286552 0
270 Joondalup Drive,
Joondalup WA 6027
Country [1] 286552 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289769 0
Joondalup Health Campus Human Research Ethics Committee
Ethics committee address [1] 289769 0
Joondalup Health Campus,
Shenton Ave,
Joondalup, WA 6027
Ethics committee country [1] 289769 0
Australia
Date submitted for ethics approval [1] 289769 0
02/09/2013
Approval date [1] 289769 0
20/09/2013
Ethics approval number [1] 289769 0
1319

Summary
Brief summary
Both Swim-up and Density gradient centrifugation are routine sperm preparation methods in IVF laboratory. However the content of seminal fluid might mix with separated sperm in the Swim-up method while centrifugation is involved in the other method which are both considered harmful to fertilisation and embryo development. The proposed study will use time-lapse technology to reveal the differeces in the subsequent embryo development.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42326 0
Mr Yanhe Liu
Address 42326 0
Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
Country 42326 0
Australia
Phone 42326 0
+61 8 9301 1075
Fax 42326 0
Email 42326 0
[email protected]
Contact person for public queries
Name 42327 0
Dr Phill Matson
Address 42327 0
Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
Country 42327 0
Australia
Phone 42327 0
+61 8 9301 1075
Fax 42327 0
Email 42327 0
[email protected]
Contact person for scientific queries
Name 42328 0
Dr Phill Matson
Address 42328 0
Fertility North
Suite 213, Specialist Medical Centre, Joondalup Health Campus, Shenton Ave, Joondalup WA 6027
Country 42328 0
Australia
Phone 42328 0
+61 8 9301 1075
Fax 42328 0
Email 42328 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

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