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
Protocol serial number	N/A
Sponsor	University Hospital Brussels (Universitair Ziekenhuis Brussel) (Belgium)
Funders	Research Council of the Vrije University Brussels (Onderzoeksraad Vrije Universiteit Brussel) (Belgium), Research Foundation of Flanders (Fonds voor Wetenschappelijk Onderzoek Vlaanderen [FWO]) (The Netherlands), Alphonse and Jean Forton Fund (Belgium)

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

Primary study design	Interventional
Study design	Randomised active-controlled parallel-group trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	09/01/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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