Contact information
Type
Scientific
Primary contact
Ms Karen Sermon
ORCID ID
Contact details
Centre for Medical Genetics
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium
+32 (0)2 477 60 73
karen.sermon@uzbrussel.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
1cell2cell
Study hypothesis
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
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)
Study design
Randomised active-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
05/01/2001
Overall trial end date
09/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
PGD cycles for monogenic diseases, sexing or screening in which one or two cells can be removed from the embryos.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
592
Participant 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.
Recruitment start date
05/01/2001
Recruitment end date
09/01/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Centre for Medical Genetics
Brussels
1090
Belgium
Sponsor information
Organisation
University Hospital Brussels (Universitair Ziekenhuis Brussel) (Belgium)
Sponsor details
Centrum Medische Genetica en Centrum Reproductieve Geneeskunde
Laarbeeklaan 101
Brussels
B-1090
Belgium
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Research Council of the Vrije University Brussels (Onderzoeksraad Vrije Universiteit Brussel) (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research Foundation of Flanders (Fonds voor Wetenschappelijk Onderzoek Vlaanderen [FWO]) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Alphonse and Jean Forton Fund (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18156649
Publication citations
-
Results
Goossens V, De Rycke M, De Vos A, Staessen C, Michiels A, Verpoest W, Van Steirteghem A, Bertrand C, Liebaers I, Devroey P, Sermon K, Diagnostic efficiency, embryonic development and clinical outcome after the biopsy of one or two blastomeres for preimplantation genetic diagnosis., Hum. Reprod., 2008, 23, 3, 481-492, doi: 10.1093/humrep/dem327.