Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001035617
Ethics application status
Approved
Date submitted
28/07/2014
Date registered
25/09/2014
Date last updated
25/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does an innovative method of sequencing, known as next generation sequencing (NGS), applied for normal embryo selection in infertile patients improve pregnancy rate in fresh transfer?
Scientific title
In patients with fertility problems, does preimplantation genetic diagnosis, compared to group without preimplantation genetic diagnosis, improve pregnancy rate?’
Secondary ID [1] 285069 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 292598 0
embryo aneuploidy 292599 0
Condition category
Condition code
Reproductive Health and Childbirth 292904 292904 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Involves patient's biopsied embryos genetic analysis. Choice of the embryos for transfer was based on the preimplantation genetic diagnosis using next generation sequencing (PGD NGS) results.
Duration: 12 hours of analysis
Frequency: Once in this investigation
Intervention code [1] 289908 0
Diagnosis / Prognosis
Comparator / control treatment
ICSI with preimplantation genetic diagnosis (PGD) vs standard treatment (ICSI without PGD). In control group selection of embryos for transfer was based on microscopic morphology analysis and rate of divisions analysis.
Control group
Active

Outcomes
Primary outcome [1] 292774 0
pregnancy rate (as ultrasound fetal heartbeat detection)
Timepoint [1] 292774 0
on 6 weeks and 1-3 days post embryo transfer
Secondary outcome [1] 309655 0
implantation rate (by transvaginal ultrasound)
Timepoint [1] 309655 0
5 weeks and 3 days +/- 2 days post embryo transfer
Secondary outcome [2] 309861 0
miscarriage rate (ultrasound)
Timepoint [2] 309861 0
up to 12 weeks post embryo transfer

Eligibility
Key inclusion criteria
1. Patients undergoing intracytoplasmic sperm injection (ICSI) in Invicta Fertility and Reproductive Centre s. z o.o. in time frame from 08.2013 to 01.2014
2. At least two previous implantation failures
Minimum age
30 Years
Maximum age
38 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with endometriosis or adenomiosis
2. Patients with problems related to endometrium thickness

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2013
Actual
1/08/2013
Date of last participant enrolment
Anticipated
1/07/2014
Actual
1/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment outside Australia
Country [1] 6256 0
Poland
State/province [1] 6256 0

Funding & Sponsors
Funding source category [1] 289677 0
Commercial sector/Industry
Name [1] 289677 0
Invicta s. z o.o.
Country [1] 289677 0
Poland
Primary sponsor type
Commercial sector/Industry
Name
Invicta s. z o.o.
Address
ul. Trzy lipy 3, 80-172 Gdansk, Poland
Country
Poland
Secondary sponsor category [1] 288370 0
None
Name [1] 288370 0
Address [1] 288370 0
Country [1] 288370 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291412 0
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej
Ethics committee address [1] 291412 0
Ethics committee country [1] 291412 0
Poland
Date submitted for ethics approval [1] 291412 0
06/05/2014
Approval date [1] 291412 0
20/05/2014
Ethics approval number [1] 291412 0
11/14

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

Contacts
Principal investigator
Name 50266 0
A/Prof Krzysztof Lukaszuk
Address 50266 0
Invicta Reproductive and Fertility Centres
ul. Trzy lipy 3, 80-172 Gdansk
Country 50266 0
Poland
Phone 50266 0
+48 58 58 58 810
Fax 50266 0
Email 50266 0
[email protected]
Contact person for public queries
Name 50267 0
Judyta Zabielska
Address 50267 0
Invicta Reproductive and Fertility Centres
ul. Trzy lipy 3, 80-172, Gdansk
Country 50267 0
Poland
Phone 50267 0
+48 516 829 691
Fax 50267 0
Email 50267 0
[email protected]
Contact person for scientific queries
Name 50268 0
Judyta Zabielska
Address 50268 0
Invicta Reproductive and Fertility Centres
ul. Trzy lipy 3, 80-172, Gdansk
Country 50268 0
Poland
Phone 50268 0
+48 516 829 691
Fax 50268 0
Email 50268 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.