Closed Vitrification of Oocytes

Study Overview
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Brief Summary
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This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.

Detailed Description
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The Cryotop method for oocyte vitrification is classified as open system, which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.

Official Title
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Impact of a Closed System in Donor Oocyte Vitrification

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Oocytes are vitrified/stored using a closed device
* Procedure: Oocytes are vitrified/stored using an open device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donors: < 35 years old Normal physical and gynecological examinations No family history of hereditary or chromosomal diseases. Normal karyotype Negative screening for sexually transmitted diseases. Oocyte recipients: Oocyte recipients < 50 years old Body mass index < 30 < 2 previous IVF failures No severe male factor No recurrent miscarriage No hidrosalpinx No myoma No adenomyosis No AMH alterations Exclusion Criteria: Donors and recipients not meeting inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitrified oocytes using closed Cryotop®<br>Oocytes are vitrified/stored using a closed device | Procedure: Oocytes are vitrified/stored using a closed device<br>* Vitrification will be carried out using a modification of the current device (Cryotop®), thus providing air tight sealing. Closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage.<br>|
| Active Comparator: Vitrified oocytes using open Cryotop®<br>Oocytes are vitrified/stored using an open device | Procedure: Oocytes are vitrified/stored using an open device<br>* The vitrification process takes place through direct contact with liquid nitrogen. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival after oocyte vitrification using the closed device Cryotop® | Survival will be evaluated morphologically two hours after warming. | >2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo development |  | From thawing and until pregnancy outcome (0-9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oocyte vitrification, survival rate, egg banking, ovum donation