Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001225808
Ethics application status
Not yet submitted
Date submitted
8/11/2012
Date registered
20/11/2012
Date last updated
20/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of calcium to improve fertilisation in patients with previous poor fertilisation or failed fertilisation and in patients with poor sperm quality.
Scientific title
The effect of oocyte activation using a calcium ionophore on fertilisation and clinical pregnancy rate following intra-cytoplasmic sperm injection (ICSI) in patients with previous poor fertilisation or failed fertilisation and for patients with severe male factor infertility.
Secondary ID [1] 281513 0
Nil
Universal Trial Number (UTN)
U1111-1136-8947
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertile patients 287782 0
Condition category
Condition code
Reproductive Health and Childbirth 288133 288133 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GM508 Cult-Active- oocytes are placed into the 1.0% calcium ionophore (GM508 Cult-Active) for 15 mins following ICSI. The oocytes are then removed, washed in our normal culture media and returned to the culture drops as per PIVET protocol. Patients may opt to have this treatment as many times as they want
Intervention code [1] 286030 0
Treatment: Other
Comparator / control treatment
The patients previous IVF/ICSI cycle in which the calcium ionophore had not been used. i.e the patient who is been treated with the calcium ionophore's previous cycle where fertilisation was reduced.

This cycle will more than likely be within 6 months of the calcium ionophore treatment cycle
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288332 0
% Clinical pregnancy rate. We have an internal data base that will calculate: the rate of number of clinical pregnancies (presence of a heartbeat at 7 week ultrasound scan)/ number of embryo transfers
Timepoint [1] 288332 0
1 year
Primary outcome [2] 288342 0
% Fertilisation rate. We have an internal data base that will calculate: the number of two pronuclear oocytes/the number of oocytes injected with sperm
Timepoint [2] 288342 0
1 year
Secondary outcome [1] 299890 0
% Blastocyst rate:We have an internal data base that will calculate: Number of blastocysts formed on Day 5 and/or Day 6/the number of two pronuclear oocytes
Timepoint [1] 299890 0
1 year
Secondary outcome [2] 299917 0
% Live Birth: Number of live babies born/number of embryo transfers
Timepoint [2] 299917 0
1-2 years

Eligibility
Key inclusion criteria
All participants will be patients of PIVET Medical Centre and under the clinical management of one or more of the Fertility Specialists who work at PIVET. No outside patients will be involved in this study. Eligible patients must have had previous complete failed fertilisation, reduced fertilisation (<50%) or have severe male factor infertility (Sperm concentration < 2 x 106 million/ml, Sperm motility < 5%
Strict criteria normal morphology < 4%). Patients with surgically collected sperm (epididymal collected sperm or testicular collected sperm) will also be included
Minimum age
21 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patients that has had fertilisation rate of greater than 50% in a previous cycle will be excluded

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)
Eligible patients must have had previous complete failed fertilisation, reduced fertilisation (<50%) or have severe male factor infertility. Patients with surgically collected sperm (epididymal collected sperm or testicular collected sperm) will also be included. Patients will be consulted by their Clinician on the benefits and risks of calcium ionophore usage. They will be given an information sheet and consent. They will need to read this information sheet. Patients will have the opportunity to discuss and ask any questions or raise any concerns about the ionophore for a second time at their routine embryologist consult before the egg collection. When or if they decide to use the ionophore, they can sign the consent. No calcium ionophore treatment will be given without a signed, witnessed consent in the patient file.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286308 0
Commercial sector/Industry
Name [1] 286308 0
PIVET Medical Centre
Country [1] 286308 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
PIVET Medical Centre
Address
166-168 Cambridge St Leederville WA 6007
Country
Australia
Secondary sponsor category [1] 285088 0
None
Name [1] 285088 0
Address [1] 285088 0
Country [1] 285088 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288369 0
Ethics committee address [1] 288369 0
Ethics committee country [1] 288369 0
Date submitted for ethics approval [1] 288369 0
01/12/2012
Approval date [1] 288369 0
Ethics approval number [1] 288369 0

Summary
Brief summary
Oocyte activation is characterised by a dramatic increase in intracellular calcium concentration followed by short high frequency calcium oscillations. This is triggered when the spermatozoa penetrates the egg. Without this calcium influx the oocyte will fail to fertilise.

Many studies have shown that the fertilsation rate can be improved as well as embryo development and consequent implantation rates, by mimicking the physiological cell-signalling mechanism using an activation agent such as a calcium ionophore.

We wish to use a commercially avaliable calcium ionophore, GM508 Cult-Active, supplied by Gynemed Germany to study this effect on our patients who have undergone a complete failed fertilization cycle or a reduced fertilzation cycle (< 50% of oocytes injected) or where severe male factor infertility is evident.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34932 0
Address 34932 0
Country 34932 0
Phone 34932 0
Fax 34932 0
Email 34932 0
Contact person for public queries
Name 18179 0
Jason Conceicao
Address 18179 0
166-168 Cambridge St Leederville WA 6007
Country 18179 0
Australia
Phone 18179 0
+61 (08)9422 5400
Fax 18179 0
Email 18179 0
[email protected]
Contact person for scientific queries
Name 9107 0
Jason Conceicao
Address 9107 0
166-168 Cambridge St Leederville WA 6007
Country 9107 0
Australia
Phone 9107 0
+61 (08)9422 5400
Fax 9107 0
Email 9107 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.