Study Stopped
NO RECRUITMENT
Closed Vitrification of Oocytes
"Impact of a Closed System in Donor Oocyte Vitrification"
2 other identifiers
interventional
N/A
1 country
2
Brief Summary
This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 29, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMarch 8, 2016
March 1, 2016
2.9 years
November 29, 2012
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival after oocyte vitrification using the closed device Cryotop®
Survival will be evaluated morphologically two hours after warming.
>2 hours
Secondary Outcomes (1)
Embryo development
From thawing and until pregnancy outcome (0-9 months)
Study Arms (2)
Vitrified oocytes using closed Cryotop®
EXPERIMENTALOocytes are vitrified/stored using a closed device
Vitrified oocytes using open Cryotop®
ACTIVE COMPARATOROocytes are vitrified/stored using an open device
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ivi Valencia
Valencia, Valencia, 46015, Spain
IVI Valencia
Valencia, 46005, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Cobo, PhD
IVI Valencia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cryo-biology Unit director at IVI Valencia, Spain
Study Record Dates
First Submitted
November 29, 2012
First Posted
December 10, 2012
Study Start
November 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 8, 2016
Record last verified: 2016-03