None listed
Conditions
Brief summary
In the past 5-10 years fertilisation rates after IVF have stayed the same (~65%), with the chance of a cycle cancelled due to failed fertilization after standard IVF insemination up to 10% higher than that of intracytoplasmic sperm injection (ICSI), which is usually less than 1%. As our understanding of sperm biology has advanced we know that the female reproductive tract activates the sperm to improve the ability of the sperm to bind and fertilize an egg. Currently, the media that are used for IVF only result in less than 20% of sperm to undergo this activation process. We have developed a new sperm media (SpermFAST) which induces these naturally occurring changes in sperm to a much higher rate (approximately 60%). Based on our understanding of sperm biology these changes should make it easier for the sperm to bind to and fertilise an egg in a dish like in IVF. This small pilot study is to determine if sperm incubated in our new sperm media (SpermFAST) are able to bind to and fertilise an egg. This will be the first time that this method has been used to activate sperm for the purpose of fertilization.
Interventions
Participation in this study will not affect the standard of care that patients receive at Repromed/Monash IVF.
During a standard IVF cycle both semen and eggs are collected from the male and female partners and co-incubated to form a healthy embryo. Semen is washed prior to IVF insemination to remove the seminal plasma and for the collection of motile sperm which currently occurs in standard sperm media (G-IVF). Usually sperm then sits in G-IVF media until insemination. In our test protocol the
Participation in this study will not affect the standard of care that patients receive at Repromed/Monash IVF. During a standard IVF cycle both semen and eggs are collected from the male and female partners and co-incubated to form a healthy embryo. Semen is washed prior to IVF insemination to remove the seminal plasma and for the collection of motile sperm which currently occurs in standard sperm media (G-IVF). Usually sperm then sits in G-IVF media until insemination. In our test protocol the sperm will be incubated in the new sperm media (SpermFAST) for 2 hours. In this study we propose to use a sibling split design such that half of all harvested eggs will be inseminated with sperm incubated in standard G-IVF and the other half of eggs inseminated with sperm incubated in SpermFAST. The eggs and media drops the two types of sperm (1: standard IVF and 2: SpermFAST) will be co-incubated in will be at the discretion of embryology laboratory staff. SpermFAST media is based off the current standard clinical media (G-IVF) however differs in the addition of 10uM of Progesterone. This will allow us to directly test the new media against the current proven standard G-IVF sperm media, while reducing the interference of patients current IVF cycle.
Sponsors
University of Adelaide
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- Any couple undergoing standard IVF insemination for assisted reproductive technology treatment. - Able to read and speak English.
Exclusion criteria
Withdrawal from study; - The quality of the washed sperm does not hit the recommended values for IVF insemination (at least 1x106/ml with 90% motility) - these patients will automatically be transferred to ICSI insemination. - Less than 6 eggs collected at egg pick up. Data suggests that less than 6 eggs collected at egg pick up is associated with increased rates of failed fertilization.
Outcome results
None listed