Diagnostic efficiency and accuracy, embryonic development and clinical outcome after the biopsy of one or two blastomeres for preimplantation genetic diagnosis
| ISRCTN | ISRCTN20762192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20762192 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 13/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Karen Sermon
Scientific
Scientific
Centre for Medical Genetics
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium
| Phone | +32 (0)2 477 60 73 |
|---|---|
| karen.sermon@uzbrussel.be |
Study information
| Study design | Randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | |
| Study acronym | 1cell2cell |
| Study objectives | Removal of one cell from a preimplantation embryo in view of preimplantation genetic diagnosis (PGD) is less detrimental than two cell removal and will lead to a higher number of ongoing pregnancies and births. |
| Ethics approval(s) | Approval received from the Commission for Medical Ethics of the Academic Hospital and Faculty of Medicine and Pharmacy of the Dutch-speaking Brussels Free University (Commissie Medische Ethiek of the [then] Academisch Ziekenhuis en Faculteit Geneeskunde en Pharmacie van de Vrije Universiteit Brussel). Since then our hospital has been renamed Universitair Ziekenhuis Brussel (UZ Brussel). The study was approved on 22nd February 2001 (ref: F.W.O. 2001/05D) |
| Health condition(s) or problem(s) studied | Preimplantation genetic diagnosis, blastomere biopsy |
| Intervention | Embryos were obtained from patients undergoing PGD. One or two cells were removed from embryos with more than six cells at day three. Embryos shown to be free of disease were replaced in the uterus. Some surplus embryos were re-analysed to measure accuracy. |
| Intervention type | Other |
| Primary outcome measure | 1. Embryo transfer rate 2. Positive human chorionic gonadotropin (hCG) 3. Implantation rate 4. Live birth rate Outcomes were measured at 9 and 18 months. |
| Secondary outcome measures | 1. In-vitro embryonic development after the removal of one or two blastomeres 2. The diagnostic efficiency of both PCR and fluorescence in situ hybridisation (FISH) techniques for PGD Outcomes were measured at 9 and 18 months. |
| Overall study start date | 05/01/2001 |
| Completion date | 09/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 592 |
| Key inclusion criteria | PGD cycles for monogenic diseases, sexing or screening in which one or two cells can be removed from the embryos. |
| Key exclusion criteria | PGD where two cells must be removed for accurate diagnosis: monogenic cycles where polymerase chain reaction (PCR) for one locus is carried out, or PGD for translocation carriers. |
| Date of first enrolment | 05/01/2001 |
| Date of final enrolment | 09/01/2005 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Centre for Medical Genetics
Brussels
1090
Belgium
1090
Belgium
Sponsor information
University Hospital Brussels (Universitair Ziekenhuis Brussel) (Belgium)
Hospital/treatment centre
Hospital/treatment centre
Centrum Medische Genetica en Centrum Reproductieve Geneeskunde
Laarbeeklaan 101
Brussels
B-1090
Belgium
| Website | http://www.brusselsivf.be/default_en.aspx?lang=EN |
|---|---|
"ROR" |
https://ror.org/038f7y939 |
Funders
Funder type
Research council
Research Council of the Vrije University Brussels (Onderzoeksraad Vrije Universiteit Brussel) (Belgium)
No information available
Research Foundation of Flanders (Fonds voor Wetenschappelijk Onderzoek Vlaanderen [FWO]) (The Netherlands)
No information available
Alphonse and Jean Forton Fund (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/03/2008 | Yes | No |
