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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12614001037695 |
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Date of registration:
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25/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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?
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Scientific title:
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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? |
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Date of first enrolment:
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01/08/2013 |
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Target sample size:
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114 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://anzctr.org.au/ACTRN12614001037695.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Poland
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Contacts
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Name:
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Ms Judyta Zabielska
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Address:
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Invicta Reproductive and Fertility Centres
ul. Trzy lipy 3, 90-172, Gdansk
Poland |
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Telephone:
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+48 516 829 691 |
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Email:
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judytazabielska@gmail.com |
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Affiliation:
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Name:
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Ms Judyta Zabielska
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Address:
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Invicta Reproductive and Fertility Centres
ul. Trzy lipy 3, 90-172, Gdansk
Poland |
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Telephone:
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+48 516 829 691 |
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Email:
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judytazabielska@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: 1. Patients with endometriosis or adenomiosis
2. Patients with problems related to endometrium thickness
Age minimum:
33 Years
Age maximum:
39 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Reproductive Health and Childbirth - Fertility including in vitro fertilisation
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fertlility problems;
fertlility problems
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Intervention(s)
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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
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Primary Outcome(s)
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pregnancy rate (as ultrasound fetal heartbeat detection)[on 6 weeks and 1-3 days post embryo transfer]
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Secondary Outcome(s)
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miscarriage rate (ultrasound)[up to 12 weeks post embryo transfer]
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implantation rate (by transvaginal ultrasound)[5 weeks and 3 days +/- 2 days post embryo transfer]
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Source(s) of Monetary Support
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Invicta s. z o.o.
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Ethics review
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Status: Approved
Approval date:
Contact:
Komisja Bioetyczna przy Okregowej Izbie Lekarskiej
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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