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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
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Infertility | Procedure: Oocytes are vitrified/stored using a closed device Procedure: Oocytes are vitrified/stored using an open device | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: Vitrified oocytes using closed Cryotop®
Oocytes are vitrified/stored using a closed device
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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
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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. |
- Survival after oocyte vitrification using the closed device Cryotop® [ Time Frame: >2 hours ]Survival will be evaluated morphologically two hours after warming.
- Embryo development [ Time Frame: From thawing and until pregnancy outcome (0-9 months) ]

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

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
Spain | |
IVI Valencia | |
Valencia, Spain, 46005 | |
Ivi Valencia | |
Valencia, Spain, 46015 |
Principal Investigator: | Ana Cobo, PhD | IVI Valencia |
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 |
Oocyte vitrification survival rate egg banking ovum donation |
Infertility |