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
Scientific
Department of Obstetrics and Gynaecology
Maternity Hospital
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/05/2003 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
Department of Obstetrics and Gynaecology
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
University of Aberdeen (UK)
University/education
University/education
c/o Sylvia M Clement
Department of Obstetrics and Gynaecology
Foresterhill
Aberdeen
AB25 2ZD
Scotland
United Kingdom
| Website | http://www.abdn.ac.uk/obsgynae |
|---|---|
"ROR" |
https://ror.org/016476m91 |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
