Efficacy of PIEZO ICSI to improve fertilisation rates of oocytes

Not Applicable

Completed

• Conditions: Infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12618000603213
• Lead Sponsor: Repromed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-18
• Study Completion: 2020-09-14
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

All participants must be patients of Repromed who have booked on for IVF treatment where their clinician recommends ICSI as insemination method of choice.
Consenting patients must have greater than or equal to 6 mature oocytes for injection post egg retrieval.

Exclusion Criteria

Gamete donor cycles
Surgical sperm collection requirements
Previous cycle with an ICSI fertilisation of <30%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
normal fertilisation rate. Fertilisation of oocytes will be assessed the morning after insemination. Normal fertilisation of an oocyte is assessed by the presence of 2 polar bodies and 2 pronuclei. This is visualised by a scientist under a microscope, no further tool or tests will be used or are applicable.. [The day after injection when fertilisation can be assessed]

Secondary Outcome Measures

Name	Time	Method
oocyte degeneration rate. This is determined visually down a microscope by a scientist and is indicated by collapse of cytoplasmic membrane and degeneration of cytoplasm. [The day after injection when fertilisation can be assessed is single time-point to assess oocyte degeneration.];embryo quality. This is determined visually down a microscope by a scientist on day 3, 4, 5 and 6 of embryo culture. [A day 3 assessment is performed to track embryo development. A day 4/day 5 assessment is performed to assess suitability for transfer and /or day 5/day 6 assessment for embryos that are of a suitable quality to be frozen ];Pregnancy rate. [This is determined by measuring the patients blood 16 days after egg collection for beta HCG level.];Fetal heart assessment [ This is measured by ultrasound at between 6 to 8 weeks post egg collection.];Miscarriage rate[This is determined as the % of pregnancies that not determined to be on going after initial fetal heart scan at 6 to 8 weeks post egg collection.]