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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000453583
• Date of registration: 11/05/2015
• Prospective Registration: No
• Primary sponsor: Fertility SA
• 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.
• Date of first enrolment: 20/04/2015
• Target sample size: 1000
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12615000453583.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Mr Ryan Rose

• Name: Mr Ryan Rose

Key inclusion & exclusion criteria

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.


Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infertility ;IVF/ICSI ;Embryo Vitrification;
Infertility


IVF/ICSI

Embryo Vitrification

Reproductive Health and Childbirth - Fertility including in vitro fertilisation

Intervention(s)

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.

Primary Outcome(s)

Live Birth[birth of a live neonate at more than 20 weeks gestation]

Secondary Outcome(s)

Clinical pregnancy rates[Pregnancy Ultrasound at 7 weeks and 12 weeks gestation. Assessed by visible live, intrauterine pregnancy with fetal heart present.]

Cryopreservation outcomes
[Post-Thaw survival at 15mins-2hours.
Re-expansion of Embryo at 15mins-2hours.
]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Fertility SA

Ethics review

Status: Approved
Approval date:
Contact:

Saint Andrews Human Research Ethics Commitee