Closed Vitrification of Oocytes

Infertility Clinical Trial

Official title:

"Impact of a Closed System in Donor Oocyte Vitrification"

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01745536
• Other study ID #: 1206-C-104-AC
• Secondary ID: Clinical Trials.
• Status: Withdrawn
• Phase: N/A
• First received: November 29, 2012
• Last updated: March 7, 2016
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia
Spain	Ivi Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival after oocyte vitrification using the closed device Cryotop®	Survival will be evaluated morphologically two hours after warming.	>2 hours	No
Secondary	Embryo development		From thawing and until pregnancy outcome (0-9 months)	No