| - candidate number | 2500 |
| - NTR Number | NTR922 |
| - ISRCTN | ISRCTN20762192 |
| - Date ISRCTN created | 11-apr-2007 |
| - date ISRCTN requested | 24-mrt-2007 |
| - Date Registered NTR | 27-feb-2007 |
| - Secondary IDs | |
| - Public Title | Diagnostic efficiency and accuracy, embryonic development and clinical outcome after the biopsy of one or two blastomeres for preimplantation genetic diagnosis. |
| - Scientific Title | Diagnostic efficiency and accuracy, embryonic development and clinical outcome after the biopsy of one or two blastomeres for preimplantation genetic diagnosis. |
| - ACRONYM | 1cell2cell |
| - hypothesis | Removal of one cell from a preimplantation embryo in view of preimplantation genetic diagnosis is less detrimental than two cell removal and will lead to a higher number of ongoing pregnancies and births. |
| - Healt Condition(s) or Problem(s) studied | Preimplantation genetic diagnosis (PGD), Blastomere biopsy |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 5-jan-2001 |
| - planned closingdate | 9-jan-2005 |
| - Target number of participants | 592 |
| - Interventions | 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. |
| - Primary outcome | 1. Embryo transfer rate; 2. Positive hCG; 3. Implantation rate; 4. Live birth rate. |
| - Secondary outcome | 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. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Karen Sermon |
| - CONTACT for SCIENTIFIC QUERIES | Karen Sermon |
| - Sponsor/Initiator | Universitair Ziekenhuis Brussel (UZB), Centrum Medische Genetica en Centrum Reproductieve Geneeskunde |
| - Funding (Source(s) of Monetary or Material Support) | Fonds voor Wetenschappelijk Onderzoek Vlaanderen, Alphonse en Jean Forton Fonds, Onderzoeksraad Vrije Universiteit Brussel |
| - Publications | Hum Reprod. 2008 Mar;23(3):481-92. Epub 2007 Dec 22. |
| - Brief summary | Preimplantation genetic diagnosis (PGD) can be considered as an alternative to prenatal diagnosis which circumvents the problem of therapeutic abortion for a genetic disease. It involves the genetic testing of blastomeres from preimplantation embryos followed by the selective transfer of embryos shown to be unaffected for the disease under study. The final goal of PGD is the birth of one healthy child and since genetic analysis is performed on one or two single blastomeres, it has to meet high standards of efficiency and accuracy. Important questions that arise are first whether the embryo development would significantly differ after the removal of only one cell as compared to two cells and secondly whether we can achieve the same level of diagnostic accuracy after the biopsy of one cell as compared to two-cell biopsy. In order to answer these questions we enrolled patients with embryo biopsy in view of PGD or PGS in a randomized controlled trial (RCT) and assessed the diagnostic efficiency and accuracy as well as further embryonic development and clinical outcome after the removal of one or two blastomeres. |
| - Main changes (audit trail) | |
| - RECORD | 27-feb-2007 - 23-jun-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl