Efficacy and Cost Effectiveness of Selective Single Embryo transfer

ISRCTN ISRCTN86466058
DOI https://doi.org/10.1186/ISRCTN86466058
Secondary identifying numbers 04/S0801/80
Submission date
29/11/2005
Registration date
16/01/2006
Last edited
12/12/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Siladitya Bhattacharya
Scientific

Department of Obstetrics & Gynaecology
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Phone +44 (0)1224 553 267
Email s.bhattacharya@abdn.ac.uk

Study information

Study designMulti-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEfficacy and Cost Effectiveness of Selective Single Embryo transfer: a multi-centre randomised controlled trial
Study acronymECoSSE
Study objectivesThat single embryo transfer is as effective and as acceptable as double embryo transfer.
Ethics approval(s)Approval received from the Grampian Local Research Ethics Committee (ref: 04/S0801/80).
Health condition(s) or problem(s) studiedInfertility
InterventionSingle-embryo transfer or double-embryo transfer.

Added 21/02/2007:
Please note that this trial has been stopped due to poor recruitment and the fact that the clinical question is less relevant as many other trials had been published since this trial was planned.
Intervention typeOther
Primary outcome measureLive birth per woman.
Secondary outcome measures1. Pregnancy rate per woman
2. Multiple pregnancy rate
3. Obstetric and perinatal morbidity
4. Cost effectiveness and cost utility
5. Acceptability and satisfaction
Overall study start date01/01/2005
Completion date31/12/2009
Reason abandoned (if study stopped)1. Participant recruitment issue 2. Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants700
Key inclusion criteria1. Women aged 37 years or less
2. Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI)
3. In the first or second cycle of treatment or with a previous IVF live birth
4. Four or more good quality embryos at the time of embryo transfer
Key exclusion criteria1. Pre-implantation genetic diagnosis
2. Assisted hatching
3. History of recurrent miscarriage (three or more)
4. Multiple IVF failure
5. Donor or recipient of gametes
6. Previous non-IVF live birth
Date of first enrolment01/01/2005
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Obstetrics & Gynaecology
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

Research & Innovation
University Office
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom

Website http://www.abdn.ac.uk/R&I
ROR logo "ROR" https://ror.org/016476m91

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 067469)

No information available

The Bertarelli Foundation (Switzerland)

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?
Protocol article Protocol 01/09/2005 Yes No