Cryopreservation of human embryos in a modified cryoprotectant solution

ISRCTN ISRCTN93314892
DOI https://doi.org/10.1186/ISRCTN93314892
Secondary identifying numbers 067469
Submission date
08/01/2007
Registration date
01/02/2007
Last edited
10/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Catriona Aird
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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(s)Grampian Research Ethics Committee (GREC), 02/04/2003 (ref: 03/ 0067).
Health condition(s) or problem(s) studiedIn Vitro Fertilisation (IVF) and Intra-Cytoplasmic Sperm Injection (ICSI)
InterventionFreezing the embryos in a solution containing 0.3M sucrose.
Intervention typeOther
Primary outcome measureRecovery 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 measures1. Implantation rate
2. Miscarriage
3. Live birth

Sample size will not allow statement of significant differences.
Overall study start date01/05/2003
Completion date01/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants200
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/05/2003
Date of final enrolment01/05/2008

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Obstetrics and Gynaecology
Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

Funders

Funder type

Charity

The Wellcome Trust (UK) (ref: 067469)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2011 Yes No
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