Can artificial blastocoele shrinkage prior to vitrification improve the vitrification process, improve post-thaw survival and improve pregnancy outcomes.

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.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000453583

Enrollment

Registered

2015-05-11

Start date

2015-04-20

Completion date

2017-10-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

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.

Outcome results