Comparison Between Three Freezing Protocols to Preserve Human Embryos
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 28, 2009 | ||||||||
| Last Updated Date | July 7, 2010 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Survival embryo rate [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00910390 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Delivery rate [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison Between Three Freezing Protocols to Preserve Human Embryos | ||||||||
| Official Title ICMJE | Randomized Comparison to Freeze Human Embryos by Either Vitrification or Slow Freezing Protocols | ||||||||
| Brief Summary | This randomized study compares three different freezing methods to store human in vitro fertilization (IVF) embryos: vitrification with two commercial kits or slow freezing. After information, all patients undergoing IVF treatment can be included in the study. If qualified, embryos at different developmental stages will be allocated between the three methods. At the end of the first year survival and developmental rates, and implantation and pregnancy rates will be analyzed in order to determine the best method. |
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| Detailed Description | Despite all the advances achieved in vitro fertilized treatments, it is known that the chances of implantation for fertilised in vitro embryo remain limited, at around 20%. Cryopreservation of supernumerary embryos produced during IVF cycles provides an opportunity for patients to increase the number of transfers per oocyte harvest cycle, increasing then their chances of conception. The freezing technique may involve different media and methods, which lead to different survival and developmental rates after thawing. Vitrification is a new freezing method, which consists in exposing cells to high concentrations of cryoprotectants and then cooling them ultra-rapidly; this induces an increase in viscosity which favours the formation of a vitreous state without any ice crystals formation. This method contrasts with the slow freezing method (currently employed), which is based on exposure to very low concentrations of cryoprotectants combined with long cooling times and associated with a higher risk of ice crystal formation. Both methods can reduce cell survival and embryo ability to develop, either by the high concentrations of cryoprotectants in case of vitrification, or by ice crystals formation in case of slow freezing. The advantages of vitrification in embryology may be considerable because embryos seem more sensitive to ice crystal formation than to cyroportectant concentration; consequently, the elimination of office crystal injury may increase their survival chances. Additionally in the case of vitrification, the time required for equilibration and cooling is considerably reduced as well as the need for expensive equipment such as programmable machine is eliminated. At present, vitrification and slow freezing are used for the cryopreservation of oocytes and embryos at all stages of development. Encouraging results have been obtained with vitrification, but no study has randomly compared in one study, the two protocols and cryoprotectors. The purpose of this clinic randomised study is to compare three treatments: traditional slow freezing method currently employed (control group) and two different commercial vitrification methods (experimental groups) to assess the efficacy that this technique may involve. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | In Vitro Fertilization | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | May 2011 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 43 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00910390 | ||||||||
| Other Study ID Numbers ICMJE | VITR-1-EMBRYOS | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Fasano Giovanna, Hospital Erasme, IVF laboratory | ||||||||
| Study Sponsor ICMJE | Erasme University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Erasme University Hospital | ||||||||
| Verification Date | May 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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