Condition category
Pregnancy and Childbirth
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.brusselsivf.be/default_en.aspx?lang=EN

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

  1. 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.

Additional files

Editorial Notes