Closed Vitrification of Oocytes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ana Cobo, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01745536
First received: November 29, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Infertility
Procedure: Oocytes are vitrified/stored using a closed device
Procedure: Oocytes are vitrified/stored using an open device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: "Impact of a Closed System in Donor Oocyte Vitrification"

Resource links provided by NLM:


Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • Survival after oocyte vitrification using the closed device Cryotop® [ Time Frame: >2 hours ] [ Designated as safety issue: No ]
    Survival will be evaluated morphologically two hours after warming.


Secondary Outcome Measures:
  • Embryo development [ Time Frame: From thawing and until pregnancy outcome (0-9 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 604
Study Start Date: November 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745536

Locations
Spain
IVI Valencia
Valencia, Spain, 46005
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
Principal Investigator: Ana Cobo, PhD IVI Valencia
  More Information

No publications provided

Responsible Party: Ana Cobo, Cryo-biology Unit director at IVI Valencia, Spain, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01745536     History of Changes
Other Study ID Numbers: 1206-C-104-AC, Clinical Trials.gov
Study First Received: November 29, 2012
Last Updated: December 7, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
Oocyte vitrification
survival rate
egg banking
ovum donation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014