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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Recruitment Status : Withdrawn (NO RECRUITMENT)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

Tracking Information
First Submitted Date  ICMJE November 29, 2012
First Posted Date  ICMJE December 10, 2012
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
Survival after oocyte vitrification using the closed device Cryotop® [ Time Frame: >2 hours ]
Survival will be evaluated morphologically two hours after warming.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
Embryo development [ Time Frame: From thawing and until pregnancy outcome (0-9 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Closed Vitrification of Oocytes
Official Title  ICMJE "Impact of a Closed System in Donor Oocyte Vitrification"
Brief Summary This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Infertility
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Vitrified oocytes using closed Cryotop®
    Oocytes are vitrified/stored using a closed device
    Intervention: Procedure: Oocytes are vitrified/stored using a closed device
  • Active Comparator: Vitrified oocytes using open Cryotop®
    Oocytes are vitrified/stored using an open device
    Intervention: Procedure: Oocytes are vitrified/stored using an open device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2012)
604
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01745536
Other Study ID Numbers  ICMJE 1206-C-104-AC
Clinical Trials.gov ( Registry Identifier: Clinical Trials.gov )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA
Study Sponsor  ICMJE Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ana Cobo, PhD IVI Valencia
PRS Account Instituto Valenciano de Infertilidad, IVI VALENCIA
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP