Closed Vitrification of Oocytes

Not Applicable

Withdrawn

• Conditions: Infertility
• Interventions: Procedure: Oocytes are vitrified/stored using a closed device; Procedure: Oocytes are vitrified/stored using an open device

• Registration Number: NCT01745536
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitrified oocytes using closed Cryotop®	Oocytes are vitrified/stored using a closed device	Oocytes are vitrified/stored using a closed device
Vitrified oocytes using open Cryotop®	Oocytes are vitrified/stored using an open device	Oocytes are vitrified/stored using an open device

Primary Outcome Measures

Name	Time	Method
Survival after oocyte vitrification using the closed device Cryotop®	>2 hours	Survival will be evaluated morphologically two hours after warming.

Secondary Outcome Measures

Name	Time	Method
Embryo development	From thawing and until pregnancy outcome (0-9 months)

Trial Locations

Locations (2)

Ivi Valencia; 🇪🇸 Valencia, Spain

IVI Valencia; 🇪🇸 Valencia, Spain