Comparison Between Three Freezing Protocols to Preserve Human Embryos

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Comparison to Freeze Human Embryos by Either Vitrification or Slow Freezing Protocols

Conditions
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Human Embryo Cryopreservation

Intervention / Treatment
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* Other: Slow freezing
* Other: VIT-Irvine
* Other: Vit-Vitrolife


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertility requiring IVF Exclusion Criteria: Women's age > 43 years Patients positive for hepatitis B or C Patients positive for HIV

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Slow Freezing<br>Standard freezing protocol (slow freezing) of preimplantation embryos | Other: Slow freezing<br>* Embryos at different developmental stages will be frozen using a solution that contains propanediol and sucrose, individually placed in high security straws, cooled with a programmator and stored in liquid nitrogen.<br>* Other names: propanediol;|
| Experimental: VIT-Irvine<br>Vitrification with Irvine solution (rapid freezing) of preimplantation embryos | Other: VIT-Irvine<br>* Embryos at different developmental stages will be frozen using the vitrification solution according to the manufacturer's instructions, individually placed in high security vitrification devices and plunged directly in liquid nitrogen for storing.<br>* Other names: DMSO;|
| Experimental: VIT-Vitrolife<br>Vitrification (rapid freezing) with Vitrolife solution | Other: Vit-Vitrolife<br>* Embryos at different developmental stages will be frozen using the vitrification solution according to the manufacturer's instructions, individually placed in high security vitrification devices and plunged directly in liquid nitrogen for storing.<br>* Other names: propanediol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival embryo rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery rate |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, embryo cryopreservation, vitrification, Human Embryo, Embryonic development, Pregnancy rate