Closed Vitrification of Oocytes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-10-31

Brief Summary

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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitrified oocytes using closed Cryotop®

Oocytes are vitrified/stored using a closed device

Group Type EXPERIMENTAL

Oocytes are vitrified/stored using a closed device

Intervention Type PROCEDURE

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.

Vitrified oocytes using open Cryotop®

Oocytes are vitrified/stored using an open device

Group Type ACTIVE_COMPARATOR

Oocytes are vitrified/stored using an open device

Intervention Type PROCEDURE

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.

Interventions

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Oocytes are vitrified/stored using a closed device

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.

Intervention Type PROCEDURE

Oocytes are vitrified/stored using an open device

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No