Clinical trial NCT01745536: Closed Vitrification of Oocytes
Official title: "Impact of a Closed System in Donor Oocyte Vitrification"
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Keywords: Oocyte vitrification
survival rate
egg banking
ovum donation
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Survival after oocyte vitrification using the closed device Cryotop®
timeFrame: >2 hours
Secondary outcomes:
measure: Embryo development
timeFrame: From thawing and until pregnancy outcome (0-9 months)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
city: Valencia
country: Spain
facility: Ivi Valencia
Study officials:
affiliation: IVI Valencia
name: Ana Cobo, PhD
role: PRINCIPAL_INVESTIGATOR
References: