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Closed Vitrification of Oocytes

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ClinicalTrials.gov Identifier: NCT01745536
Recruitment Status : Withdrawn (NO RECRUITMENT)
First Posted : December 10, 2012
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA

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

Condition or disease Intervention/treatment Phase
Infertility Procedure: Oocytes are vitrified/stored using a closed device Procedure: Oocytes are vitrified/stored using an open device Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: "Impact of a Closed System in Donor Oocyte Vitrification"
Study Start Date : November 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitrified oocytes using closed Cryotop®
Oocytes are vitrified/stored using a closed device
 Procedure: 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.
Active Comparator: Vitrified oocytes using open Cryotop®
Oocytes are vitrified/stored using an open device
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Survival after oocyte vitrification using the closed device Cryotop® [ Time Frame: >2 hours ]
    Survival will be evaluated morphologically two hours after warming.


Secondary Outcome Measures :
  1. Embryo development [ Time Frame: From thawing and until pregnancy outcome (0-9 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745536


Locations
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Spain
IVI Valencia
Valencia, Spain, 46005
Ivi Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
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Principal Investigator: Ana Cobo, PhD IVI Valencia
More Information
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Responsible Party: Ana Cobo, Cryo-biology Unit director at IVI Valencia, Spain, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01745536    
Other Study ID Numbers: 1206-C-104-AC
Clinical Trials.gov ( Registry Identifier: Clinical Trials.gov )
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Keywords provided by Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA:
Oocyte vitrification
survival rate
egg banking
ovum donation
Additional relevant MeSH terms:
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Infertility