Efficacy and Cost Effectiveness of Selective Single Embryo transfer

ISRCTN	ISRCTN86466058
DOI	https://doi.org/10.1186/ISRCTN86466058
Protocol serial number	04/S0801/80
Sponsor	University of Aberdeen (UK)
Funders	The Wellcome Trust (UK) (grant ref: 067469), The Bertarelli Foundation (Switzerland)

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

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

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Efficacy and Cost Effectiveness of Selective Single Embryo transfer: a multi-centre randomised controlled trial
Study acronym	ECoSSE
Study objectives	That 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) studied	Infertility
Intervention	Single-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 type	Other
Primary outcome measure(s)	Live birth per woman.
Key secondary outcome measure(s)	1. Pregnancy rate per woman 2. Multiple pregnancy rate 3. Obstetric and perinatal morbidity 4. Cost effectiveness and cost utility 5. Acceptability and satisfaction
Completion date	31/12/2009
Reason abandoned (if study stopped)	1. Participant recruitment issue 2. Objectives no longer viable

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	700
Key inclusion criteria	1. 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 criteria	1. 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 enrolment	01/01/2005
Date of final enrolment	31/12/2009

Department of Obstetrics & Gynaecology

Aberdeen
AB25 2ZD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	01/09/2005		Yes	No