Condition category
Pregnancy and Childbirth
Date applied
08/01/2007
Date assigned
01/02/2007
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Catriona Aird

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
Maternity Hospital
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

067469

Study information

Scientific title

Acronym

Study hypothesis

The aim of the study is to improve the outcome of human embryo freezing. The immediate objective is to increase the proportion of embryos surviving cryopreservation with all blastomeres intact.

We hypothesise that an increase (from 0.1M to 0.3M) in the sucrose content of the freezing solution will increase the survival of slowly cooled cleavage stage human embryos. A greater proportion of cleavage stage embryos will survive with all cells intact and the increased survival will be reflected in the rate of implantation.

Ethics approval

Grampian Research Ethics Committee (GREC), 02/04/2003 (ref: 03/ 0067).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

In Vitro Fertilisation (IVF) and Intra-Cytoplasmic Sperm Injection (ICSI)

Intervention

Freezing the embryos in a solution containing 0.3M sucrose.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Recovery of intact embryos after thawing: with 75 patients having embryos thawed in each arm, the study has a 90% power at 5% level of significance of detecting a 25% increase in the proportion of women with at least two intact embryos after thawing the whole cohort.

Since some patients may not return for thawing for several years we estimate that we need to freeze for at least 100 patients in each arm. We allowed two years to recruit and freeze, plus a further two years for sufficient thawing. We hope that a later follow up will also be possible.

Secondary outcome measures

1. Implantation rate
2. Miscarriage
3. Live birth

Sample size will not allow statement of significant differences.

Overall trial start date

01/05/2003

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. In Vitro Fertilisation (IVF) and Intra-Cytoplasmic Sperm Injection (ICSI) patients - new patients and returning patients who were not previously approached for the trial
2. Patients using donor sperm if donor consented to research
3. Patients who consented but did not have sufficient embryos to enter the trial may be approached in a later cycle (re-consent needed)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Women in ECoSSE trial (see ISRCTN86466058 for details of this trial)
2. Women with two or more previous cycles but no freezing
3. Women 38 or over with one previous cycle but no freezing
4. Recipients of eggs

Recruitment start date

01/05/2003

Recruitment end date

01/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Obstetrics and Gynaecology
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Organisation

University of Aberdeen (UK)

Sponsor details

c/o Sylvia M Clement
Department of Obstetrics and Gynaecology
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Sponsor type

University/education

Website

http://www.abdn.ac.uk/obsgynae

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (ref: 067469)

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21586432

Publication citations

  1. Results

    Wood MJ, Mollison J, Harrild K, Ferguson E, McKay T, Srikantharajah A, Bell L, Bhattacharya S, A pragmatic RCT of conventional versus increased concentration sucrose in freezing and thawing solutions for human embryos., Hum. Reprod., 2011, 26, 8, 1987-1996, doi: 10.1093/humrep/der147.

Additional files

Editorial Notes