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Trial registered on ANZCTR


Registration number
ACTRN12619000370101
Ethics application status
Approved
Date submitted
27/02/2019
Date registered
8/03/2019
Date last updated
17/02/2020
Date data sharing statement initially provided
8/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can incubating sperm in a new sperm washing media 'SpermFAST', prior to in vitro fertilization (IVF) result in fertilization.
Scientific title
Incubating sperm in a new sperm washing media 'SpermFAST' to induce post ejaculation maturation prior to IVF result in fertilization.
Secondary ID [1] 297557 0
Nil
Universal Trial Number (UTN)
U1111-1229-3404
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 311778 0
sub fertility 311857 0
Condition category
Condition code
Reproductive Health and Childbirth 310394 310394 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313786 0
Treatment: Other
Comparator / control treatment
This study will utilize a sibling split model such that half of your eggs will be inseminated with sperm incubated in standard G-IVF (reference) and the other half of your eggs inseminated with sperm incubated in SpermFAST (treatment). Therefore each participant will serve as their own control.
Control group
Active

Outcomes
Primary outcome [1] 319282 0
Failed Fertilisation
~16h post insemination embryo laboratory staff will assess the egg for signs of fertilization by for the presences of 2 pro-nuclei. Eggs without 2 clearly defined pro-nuclei will be deemed not fertilized.
Timepoint [1] 319282 0
16-20 hrs post co incubation of sperm and eggs
Secondary outcome [1] 367554 0
Fertilisation rate (%)
~16h post insemination embryo laboratory staff will assess the egg for signs of fertilization by for the presences of 2 pro-nuclei. Eggs with 2 clearly defined pro-nuclei will be deemed fertilized. Fertilization rate will be calculated by the number of fertilized eggs to the total number of eggs inseminated.
Timepoint [1] 367554 0
16-20 hrs post co incubation of sperm and eggs

Eligibility
Key inclusion criteria
- Any couple undergoing standard IVF insemination for assisted reproductive technology treatment.
- Able to read and speak English.
Minimum age
22 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
We propose to use a sibling split design such that half of all collected eggs will be inseminated with sperm incubated in standard G-IVF and the other half of collected eggs inseminated with sperm incubated in SpermFAST. Each participate will serve as their own control as this will allow us to directly test the new media against the current proven standard G-IVF sperm media.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power Analysis
Primary outcome = Failed fertilization
True Mean = 65
Null Hypothesis = 0
Standard Deviation = 50

We will require 8 participants for this pilot trial.

We also have a clause of termination for the trial, if SpermFAST results in complete failed fertilization but normal fertilization in the sibling control in more than three consecutive patients the study will cease.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 13276 0
Repromed Day Surgery - Dulwich
Recruitment postcode(s) [1] 25841 0
5065 - Dulwich
Recruitment postcode(s) [2] 25842 0
2151 - North Parramatta

Funding & Sponsors
Funding source category [1] 302109 0
Commercial sector/Industry
Name [1] 302109 0
Medical Research and Education Fund (MREF) Monash IVF Group
Address [1] 302109 0
252/256 Clayton Rd, Clayton VIC 3168
Country [1] 302109 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Tec, Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 301939 0
Commercial sector/Industry
Name [1] 301939 0
Repromed
Address [1] 301939 0
180 Fullarton Rd, Dulwich, SA 5065
Country [1] 301939 0
Bahamas

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302788 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 302788 0
Research Services
THE UNIVERSITY OF ADELAIDE
SA 5005 AUSTRALIA
Ethics committee country [1] 302788 0
Australia
Date submitted for ethics approval [1] 302788 0
Approval date [1] 302788 0
18/09/2017
Ethics approval number [1] 302788 0
H-2017-172

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91406 0
Dr Nicole McPherson
Address 91406 0
Level 5, AHMS
University of Adelaide
Adelaide, SA 5005
Country 91406 0
Australia
Phone 91406 0
+61 0409 678 095
Fax 91406 0
Email 91406 0
nicole.mcpherson@adelaide.edu.au
Contact person for public queries
Name 91407 0
Dr Nicole McPherson
Address 91407 0
Level 5, AHMS
University of Adelaide
Adelaide, SA 5005
Country 91407 0
Australia
Phone 91407 0
+61 0409 678 095
Fax 91407 0
Email 91407 0
nicole.mcpherson@adelaide.edu.au
Contact person for scientific queries
Name 91408 0
Dr Nicole McPherson
Address 91408 0
Level 5, AHMS
University of Adelaide
Adelaide, SA 5005
Country 91408 0
Australia
Phone 91408 0
+61 0409 678 095
Fax 91408 0
Email 91408 0
nicole.mcpherson@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not covered by current ethics.
What supporting documents are/will be available?
No other documents available
Summary results
No Results