Ignite Creation Date:
2024-05-06 @ 1:09 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01745536
Status:
WITHDRAWN
Last Update Posted:
2016-03-08
First Post:
2012-11-29
Brief Title:
Closed Vitrification of Oocytes
Sponsor:
Instituto Valenciano de Infertilidad IVI VALENCIA
Organization:
Instituto Valenciano de Infertilidad IVI VALENCIA
Study Overview
Official Title:
Impact of a Closed System in Donor Oocyte Vitrification
Status:
WITHDRAWN
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
NO RECRUITMENT
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Clinical Trialsgov | REGISTRY | Clinical Trialsgov | None |