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Trial registered on ANZCTR


Registration number
ACTRN12614001037695
Ethics application status
Approved
Date submitted
28/07/2014
Date registered
25/09/2014
Date last updated
4/02/2016
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 frozen transfer?
Scientific title
In patients with fertility problems, does next generation sequencing-based preimplantation genetic diagnosis followed by frozen blastocyst embryo transfer, compared to group without preimplantation genetic diagnosis, improve pregnancy rate?
Secondary ID [1] 285054 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fertlility problems 292600 0
Condition category
Condition code
Reproductive Health and Childbirth 292908 292908 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preimplantation genetic diagnosis using next generation sequencing. Involves patient's biopsied embryos genetic analysis. Choice of the embryos for transfer was based on the PGD NGS results.
Duration: 12 hours of analysis
Frequency: Once in this investigation
Intervention code [1] 289909 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] 292775 0
pregnancy rate (as ultrasound fetal heartbeat detection)
Timepoint [1] 292775 0
on 6 weeks and 1-3 days post embryo transfer
Secondary outcome [1] 309657 0
implantation rate (by transvaginal ultrasound)
Timepoint [1] 309657 0
5 weeks and 3 days +/- 2 days post embryo transfer
Secondary outcome [2] 309862 0
miscarriage rate (ultrasound)
Timepoint [2] 309862 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
33 Years
Maximum age
39 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
1/01/2014
Actual
1/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment outside Australia
Country [1] 6257 0
Poland
State/province [1] 6257 0

Funding & Sponsors
Funding source category [1] 289678 0
Commercial sector/Industry
Name [1] 289678 0
Invicta s. z o.o.
Country [1] 289678 0
Poland
Primary sponsor type
Commercial sector/Industry
Name
Invicta s. z o.o.
Address
ul. Trzy lipy 3, 80-172, Gdansk
Country
Poland
Secondary sponsor category [1] 288371 0
None
Name [1] 288371 0
Address [1] 288371 0
Country [1] 288371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291413 0
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej
Ethics committee address [1] 291413 0
ul. Sniadeckich 33, 80-204 Gdansk, Poland
Ethics committee country [1] 291413 0
Poland
Date submitted for ethics approval [1] 291413 0
06/05/2014
Approval date [1] 291413 0
20/05/2014
Ethics approval number [1] 291413 0
12/14

Summary
Brief summary
Our objective was to determine pregnancy rate after comprehensive chromosome screening (CCS) using PGD NGS in frozen embryo transfer cycles after blastocyst’s trophoectoderm biopsy. 40 patients who decided to undergo PGD on 24 chromosomes on blastocystes with vitrification and frozen embryo transfer were included in the study as an investigated group. As a control group we selected 74 cases which were comparable in age, anty-mullerian hormone level (AMH), antral follicle count (AFC) and causes of infertility. Only first IVF cycles were taken under consideration.
Trial website
Trial related presentations / publications
N/A
Public notes
We have been performing preimplantation genetic diagnosis (PGD) for many years now (using FISH method). As we decided to introduce a new and more reliable tool for PGD - next generation sequencing (NGS) we submitted appropriate application to Ethics Committee before enrolment of first patient. We didn't receive Committee consent but a notification that such agreement is not necessary in case of routine research like PGD. However, after our insistence we received a consent retrospectively in which the Committee explained that their had agreed although their agreement was not necessary in this case.

Contacts
Principal investigator
Name 50206 0
A/Prof Krzysztof Lukaszuk
Address 50206 0
Invicta Reproductive and Fertility Centres
ul. Trzy lipy 3, 90-172, Gdansk
Country 50206 0
Poland
Phone 50206 0
+48 58 58 58 810
Fax 50206 0
Email 50206 0
[email protected]
Contact person for public queries
Name 50207 0
Judyta Zabielska
Address 50207 0
Invicta Reproductive and Fertility Centres
ul. Trzy lipy 3, 90-172, Gdansk
Country 50207 0
Poland
Phone 50207 0
+48 516 829 691
Fax 50207 0
Email 50207 0
[email protected]
Contact person for scientific queries
Name 50208 0
Judyta Zabielska
Address 50208 0
Invicta Reproductive and Fertility Centres
ul. Trzy lipy 3, 90-172, Gdansk
Country 50208 0
Poland
Phone 50208 0
+48 516 829 691
Fax 50208 0
Email 50208 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

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