Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001289808
Ethics application status
Not yet submitted
Date submitted
10/12/2012
Date registered
13/12/2012
Date last updated
13/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of EmbryoGen in recurrent miscarriage and/or implantation failure patients
Scientific title
The use of EmbryoGen to improve the clinical pregnancy and miscarriage rate in women who have recurrent miscarriage and/or implantation failure
Secondary ID [1] 281638 0
None
Universal Trial Number (UTN)
U1111-1137-7828
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 287924 0
Recurrent miscarriage 287925 0
Implantation failure 287926 0
Condition category
Condition code
Reproductive Health and Childbirth 288305 288305 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have had greater than or equal to 1 miscarriage or at least three IVF cycles or FET cycles were embryos have failed to implant will be offered commercially avaliable EmbryoGen 'Registered Trademark' media by there clinician. The patient and partner will be provided with an information sheet and asked to sign a consent form prior to enrollment. They will be made aware of the risks, costs and benefits of the treatment as well as that their individualised IVF treatment plan will not be affected by participating in the trial

EmbryoGen 'Registered Trademark' media will be allowed to equilibrate for a minimum of 2 hours in 5-6% CO2 at 37 degrees celsius prior to use.

Recover oocytes as usual and prepare sperm according to preferred procedure.

Carry out fertilisation (Day 0) in pre- equilibrated EmbryoGen 'Registered Trademark'. Where ICSI is required the sperm injection is performed in pre-equilibrated holding medium.

At 16-20 hours (Day 1) after insemination, IVF or ICSI, check for formation of pronuclei, then carefully wash and transfer zygotes to fresh microdrops of EmbryoGen 'Registered Trademark' ( 10 micro litres). Cover with Liquid Paraffin.

Embryo transfer at Day 3. Patients will be made aware that they can only have a Day 3 transfer when using EmbryoGen

The embryos are prepared and transferred to the uterus in pre- equilibrated EmbryoGen 'Registered Trademark' (e.g. 20 to 30 micro litres).
Flush the transfer catheter with EmbryoGen 'Registered Trademark' prior to use.

We wish to continue the study until we have 400 oocytes in each arm where the confidence level is 95% and the confidence interval is 5%. Patients can have multiple cycles with EmbryoGen 'Registered Trademark'
Intervention code [1] 286176 0
Prevention
Intervention code [2] 286177 0
Treatment: Drugs
Comparator / control treatment
Historical data from previous IVF cycles the patients have had without EmbryoGen. Historical data will be collected from 2010-2012
Control group
Historical

Outcomes
Primary outcome [1] 288477 0
Clinical Pregnancy Rate- number of clinical pregnancies (fetal heartbeat at 7 weeks U/S scan)/number of embryo transfers
Timepoint [1] 288477 0
One year
Primary outcome [2] 288478 0
Miscarriage rate- number of miscarriage/number of pregnancies (+ve hCG at pregnancy test)
Timepoint [2] 288478 0
One year
Secondary outcome [1] 300268 0
Oocyte fertilisation rate- number of 2pn embryos/number of M2 oocytes inseminated
Timepoint [1] 300268 0
one year
Secondary outcome [2] 300270 0
Day 3 embryo quality- number of good quality day 3 embryos (grade 2.5/4 or above)/number of 2pn embryos
Timepoint [2] 300270 0
one year
Secondary outcome [3] 300272 0
Implantation rate- number of pregnancy sacs by ultrasound scanning/number of embryos transferred
Timepoint [3] 300272 0
one year
Secondary outcome [4] 300273 0
Live Birth Rate- number of live births/number of embryo transfers
Timepoint [4] 300273 0
one year
Secondary outcome [5] 300274 0
Congenital abnormality rates- number of abnormalities/number of live births
Timepoint [5] 300274 0
One year

Eligibility
Key inclusion criteria
Eligible patients must be 25-45 yrs old and have had greater than or equal to 1 miscarriage or at least three IVF cycles or FET cycles where embryos have failed to implant. They are required to have had at least 1 egg collection at PIVET without the use of EmbryoGen. The data collected from these cycles will act as the control. Patients who have a known reason for the miscarriage such as translocation or uterine pathology (fibroids, polyps) will be excluded.
Minimum age
25 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No history of miscarriage, First IVF cycle, Uterine factors (fibroids, polyps ect.), Translocations, Genetic causes other than aneuploidy

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)
Patients who fall within the inclusion criteria will be offered the use of EmbryoGen on their next IVF cycle at a consult with their clinician. The clinician will explain to the patients the advantages and disadvantages of EmbryoGen use. Patients will be provided with an information sheet as well as product brouchers. Patients will be required to read the information sheet and encourage to go away and digest the information before signing a consent to use EmbryoGen. The patients will have an opportunity to ask questions regarding EmbryoGen at their pre IVF embryology appointment.
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
Patients having EmbryoGen are required to have had at least 1 egg collection at PIVET without the use of EmbryoGen. The data collected from these cycles will act as the control.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Chi squared and students t-test

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2013
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)
WA

Funding & Sponsors
Funding source category [1] 286444 0
Commercial sector/Industry
Name [1] 286444 0
PIVET Medical Centre
Country [1] 286444 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] 285231 0
None
Name [1] 285231 0
Address [1] 285231 0
Country [1] 285231 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288521 0
Curtin Ethics Committee
Ethics committee address [1] 288521 0
Ethics committee country [1] 288521 0
Australia
Date submitted for ethics approval [1] 288521 0
24/12/2012
Approval date [1] 288521 0
Ethics approval number [1] 288521 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36478 0
Dr John Yovich
Address 36478 0
PIVET Medical Centre
166-168 Cambridge St
Leederville WA 6007
Country 36478 0
Australia
Phone 36478 0
+610894225400
Fax 36478 0
Email 36478 0
[email protected]
Contact person for public queries
Name 36479 0
Jason Conceicao
Address 36479 0
PIVET Medical Centre
166-168 Cambridge St
Leederville WA 6007
Country 36479 0
Australia
Phone 36479 0
+610894225400
Fax 36479 0
Email 36479 0
[email protected]
Contact person for scientific queries
Name 36480 0
Jason Conceicao
Address 36480 0
PIVET Medical Centre
166-168 Cambridge St
Leederville WA 6007
Country 36480 0
Australia
Phone 36480 0
+610894225400
Fax 36480 0
Email 36480 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.