Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000453583
Ethics application status
Approved
Date submitted
27/04/2015
Date registered
11/05/2015
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can artificial blastocoele shrinkage prior to vitrification improve the vitrification process, improve post-thaw survival and improve pregnancy outcomes.
Scientific title
For patients undertaking IVF/ICSI cycles, who have remaining good quality embryos for vitrification, will assisted collapse of the blastocoele cavity prior to vitrification improve the vitrification process, improve post-thaw survival and improve pregnancy outcomes.
Secondary ID [1] 286598 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility

 294898 0
IVF/ICSI
 294939 0
Embryo Vitrification 294940 0
Condition category
Condition code
Reproductive Health and Childbirth 295144 295144 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Techniques for freezing embryos produced in the laboratory using assisted reproductive technology are constantly being modified and improved. Vitrification, a rapid cooling method, has overtaken the slow freezing technique for preserving embryos for use in frozen cycles, and one of the latest major advances has been artificial shrinkage of the blastocoele cavity.
Following an IVF/ICSI cycle with remaining embryos deemed worthy of vitrification and storage, each couple will be randomly allocated to Assisted Collapse Vitrification or Standard Vitrification group. Assisted Collapse Vitrification embryos will undergo zona drilling with a Zilos TK Laser to assist the embryo's collapse prior to standard vitrification in Vitrolife, RapidVit™ medium.
Upon patients request for frozen embryo transfer (FET), (embryo transfer refers to a step in the process of assisted reproduction in which embryos are placed into the uterus of a female with the intent to establish a pregnancy) single embryos will be thawed and cryopresevation outcomes assessed. Following embryo transfer, clinical outcomes will be assessed.
Intervention code [1] 291719 0
Treatment: Devices
Comparator / control treatment
Standard Vitrification (Vitrolife, RapidVit™)
Control group
Active

Outcomes
Primary outcome [1] 294909 0
Live Birth
Timepoint [1] 294909 0
birth of a live neonate at more than 20 weeks gestation
Secondary outcome [1] 314323 0
Cryopreservation outcomes
Timepoint [1] 314323 0
Post-Thaw survival at 15mins-2hours.
Re-expansion of Embryo at 15mins-2hours.
Secondary outcome [2] 314500 0
Clinical pregnancy rates
Timepoint [2] 314500 0
Pregnancy Ultrasound at 7 weeks and 12 weeks gestation. Assessed by visible live, intrauterine pregnancy with fetal heart present.

Eligibility
Key inclusion criteria
Any couple whom are using their own gametes and undertaking IVF/ICSI cycle and planning on an embryo transfer, who have suitable embryos for vitrification at the time of their fresh embryo transfer.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who are undertaking an IVF cycle for;
Egg or embryo preservation and there is no plan to transfer an embryo.
Prenatal Genetic Screening (PGS) where laser pulse is already being used.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/04/2015
Actual
20/04/2015
Date of last participant enrolment
Anticipated
Actual
30/10/2017
Date of last data collection
Anticipated
21/11/2018
Actual
Sample size
Target
1000
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 9607 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 291166 0
Commercial sector/Industry
Name [1] 291166 0
Fertility SA
Country [1] 291166 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fertility SA
Address
Fertility SA,
St Andrews Hospital
350 South Tce, Adelaide
South Australia, 5000
Country
Australia
Secondary sponsor category [1] 289846 0
None
Name [1] 289846 0
Address [1] 289846 0
Country [1] 289846 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292740 0
Saint Andrews Human Research Ethics Commitee
Ethics committee address [1] 292740 0
St Andrews Hospital
350 South Tce, Adelaide
South Australia, 5000
Ethics committee country [1] 292740 0
Australia
Date submitted for ethics approval [1] 292740 0
04/02/2015
Approval date [1] 292740 0
27/03/2015
Ethics approval number [1] 292740 0
86

Summary
Brief summary
In many cases, an IVF cycle can result in many embryos of good quality. In Australia, Single Embryo Transfer (SET) is preferred and therefore remaining embryos are either discarded or undergo vitrification, which is a process of rapidly cooling embryos, and stored at -196°C. The embryo vitrification protocol causes rapid changes in temperature which can cause instability in some embryos and result in a failure to survive the thaw process, with approximately 1 in 10 embryos failing doing so. It is proposed that in order for an embryo to survive vitrification, it needs to “collapse” from its expanded state, to a compact group of cells. In its collapsed state the embryo is thought to be protected.

Around the world, fertility clinics are changing vitrification protocols to include assisted or artificial collapse of the embryo prior to vitrification. This has resulted in many clinics demonstrating significant improvements in both the number of embryos surviving vitrification and pregnancy outcomes. We plan to compare our normal vitrification protocol with this new method of artificial collapse prior to of normal vitrification protocol, to see if we can improve both embryo survival and pregnancy outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56814 0
Mr Michael Barry
Address 56814 0
Fertility SA,
St Andrews Hospital
350 South Tce, Adelaide
South Australia, 5000
Country 56814 0
Australia
Phone 56814 0
+61 8 8408 2060
Fax 56814 0
Email 56814 0
mbarry@fertilitysa.com.au
Contact person for public queries
Name 56815 0
Ryan Rose
Address 56815 0
Fertility SA,
St Andrews Hospital
350 South Tce, Adelaide
South Australia, 5000
Country 56815 0
Australia
Phone 56815 0
+61 8 8408 2060
Fax 56815 0
Email 56815 0
rrose@fertilitysa.com.au
Contact person for scientific queries
Name 56816 0
Ryan Rose
Address 56816 0
Fertility SA,
St Andrews Hospital
350 South Tce, Adelaide
South Australia, 5000
Country 56816 0
Australia
Phone 56816 0
+61 8 8408 2060
Fax 56816 0
Email 56816 0
rrose@fertilitysa.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
0


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.