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
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
-
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.