Contact information
Type
Scientific
Primary contact
Dr Siladitya Bhattacharya
ORCID ID
Contact details
Department of Obstetrics & Gynaecology
University of Aberdeen
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 553 267
s.bhattacharya@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
04/S0801/80
Study information
Scientific title
Efficacy and Cost Effectiveness of Selective Single Embryo transfer: a multi-centre randomised controlled trial
Acronym
ECoSSE
Study hypothesis
That single embryo transfer is as effective and as acceptable as double embryo transfer.
Ethics approval
Approval received from the Grampian Local Research Ethics Committee (ref: 04/S0801/80).
Study design
Multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/01/2005
Overall trial end date
31/12/2009
Reason abandoned
1. Participant recruitment issue
2. Objectives no longer viable
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
700
Participant 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
Recruitment start date
01/01/2005
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Obstetrics & Gynaecology
Aberdeen
AB25 2ZD
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
Research & Innovation
University Office
King's College
Aberdeen
AB24 3FX
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (grant ref: 067469)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Bertarelli Foundation (Switzerland)
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
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/15905288
Publication citations
-
Protocol
Porter M, Bhattacharya S, Investigation of staff and patients' opinions of a proposed trial of elective single embryo transfer., Hum. Reprod., 2005, 20, 9, 2523-2530, doi: 10.1093/humrep/dei094.