Condition category
Pregnancy and Childbirth
Date applied
29/11/2005
Date assigned
16/01/2006
Last edited
12/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.abdn.ac.uk/R&I

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

  1. 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.

Additional files

Editorial Notes