Cryopreservation of human embryos in a modified cryoprotectant solution

ISRCTN	ISRCTN93314892
DOI	https://doi.org/10.1186/ISRCTN93314892
Protocol serial number	067469
Sponsor	University of Aberdeen (UK)
Funder	The Wellcome Trust (UK) (ref: 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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Grampian Research Ethics Committee (GREC), 02/04/2003 (ref: 03/ 0067).
Health condition(s) or problem(s) studied	In Vitro Fertilisation (IVF) and Intra-Cytoplasmic Sperm Injection (ICSI)
Intervention	Freezing the embryos in a solution containing 0.3M sucrose.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	1. Implantation rate 2. Miscarriage 3. Live birth Sample size will not allow statement of significant differences.
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	200
Key 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)
Key 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
Date of first enrolment	01/05/2003
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Department of Obstetrics and Gynaecology

Aberdeen
AB25 2ZD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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