Closed Vitrification of Oocytes

• ClinicalTrials.gov Identifier: NCT01745536
• Recruitment Status: Withdrawn
• First Posted: December 10, 2012
• Last Update Posted: March 8, 2016
• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Information provided by (Responsible Party): Ana Cobo, Instituto Valenciano de Infertilidad, IVI VALENCIA

Study Description

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

• 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

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

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

• 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

Locations

Spain

IVI Valencia

Valencia, Spain, 46005

Ivi Valencia

Valencia, Spain, 46015

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

• Principal Investigator: Ana Cobo, PhD; IVI Valencia

More Information

• 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
• 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:

Infertility