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

Centre for Medical Genetics
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium

Phone +32 (0)2 477 60 73
Email karen.sermon@uzbrussel.be

Study information

Study designRandomised active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific title
Study acronym1cell2cell
Study objectivesRemoval 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) studiedPreimplantation genetic diagnosis, blastomere biopsy
InterventionEmbryos 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 typeOther
Primary outcome measure1. 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 measures1. 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 date05/01/2001
Completion date09/01/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants592
Key inclusion criteriaPGD cycles for monogenic diseases, sexing or screening in which one or two cells can be removed from the embryos.
Key exclusion criteriaPGD 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 enrolment05/01/2001
Date of final enrolment09/01/2005

Locations

Countries of recruitment

  • Belgium
  • Netherlands

Study participating centre

Centre for Medical Genetics
Brussels
1090
Belgium

Sponsor information

University Hospital Brussels (Universitair Ziekenhuis Brussel) (Belgium)
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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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