Efficacy and Cost Effectiveness of Selective Single Embryo transfer
ISRCTN | ISRCTN86466058 |
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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
Scientific
Department of Obstetrics & Gynaecology
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
Phone | +44 (0)1224 553 267 |
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s.bhattacharya@abdn.ac.uk |
Study information
Study design | Multi-centre randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | Live birth per woman. |
Secondary outcome measures | 1. 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 date | 01/01/2005 |
Completion date | 31/12/2009 |
Reason abandoned (if study stopped) | 1. Participant recruitment issue 2. Objectives no longer viable |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Department of Obstetrics & Gynaecology
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
Research & Innovation
University Office
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom
Website | http://www.abdn.ac.uk/R&I |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | Protocol | 01/09/2005 | Yes | No |