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Main
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Note: This record shows only the 20 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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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR922 |
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Date of registration:
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27/02/2007 |
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Primary sponsor: |
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Public title:
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Diagnostic efficiency and accuracy, embryonic development and clinical outcome after the biopsy of one or two blastomeres for preimplantation genetic diagnosis.
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Scientific title:
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Diagnostic efficiency and accuracy, embryonic development and clinical outcome after the biopsy of one or two blastomeres for preimplantation genetic diagnosis. - 1cell2cell |
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Date of first enrolment:
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5/1/2001 |
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Target sample size:
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592 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=922 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Karen
Sermon |
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Address:
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Centre for Medical Genetics, UZ Brussel, Laarbeeklaan 101
1090
Brussels
Belgium |
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Telephone:
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+32 2 477 60 73 |
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Email:
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karen.sermon@uzbrussel.be |
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Affiliation:
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Name:
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Karen
Sermon |
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Address:
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Centre for Medical Genetics, UZ Brussel, Laarbeeklaan 101
1090
Brussels
Belgium |
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Telephone:
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+32 2 477 60 73 |
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Email:
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karen.sermon@uzbrussel.be |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: PGD cycles for monogenic diseases, sexing or screening in which one or two cells can be removed from the embryos.
Exclusion criteria: PGD where two cells must be removed for accurate diagnosis: monogenic cycles where PCR for one locus is carried out, or PGD for translocation carriers.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Preimplantation genetic diagnosis (PGD), Blastomere biopsy
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Intervention(s)
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Embryos were obtained from patients undergoing PGD. One or two cells were removed from embryos with more than 6 cells at day 3. Embryos shown to be free of disease were replaced in the uterus. Some surplus embryos were re-analysed to measure accuracy.
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Primary Outcome(s)
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1. Embryo transfer rate;
2. Positive hCG;
3. Implantation rate;
4. Live birth rate.
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Secondary Outcome(s)
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1. In-vitro embryonic development after the removal of one or two blastomeres;
2. The diagnostic efficiency of both PCR- and FISH techniques for PGD.
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Secondary ID(s)
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ISRCTN20762192
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Source(s) of Monetary Support
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Fonds voor Wetenschappelijk Onderzoek Vlaanderen, Alphonse en Jean Forton Fonds, Onderzoeksraad Vrije Universiteit Brussel
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