Oocyte Survival After Vitrification in an Open or Closed Device With Closed Storage.

Survival Clinical Trial

Official title:

Oocyte Survival After Vitrification in an Open or Closed Commercial Device: Study on Sibling Donor Oocytes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952184
• Other study ID #: 2013/777
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: December 2, 2015
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The survival rate (and embryo quality) of donor oocytes with two commercially available devices.

Description:

Donor sibling oocytes will be vitrified with two commercially available devices. The first device is closed vitrification with closed storage and the second device is open vitrification with closed storage. Oocyte acceptors receive oocytes from both devices. With the increase in cooling rate generated by the open vitrification (second device), we expect to get an increase in survival rate of 10%. Besides this, embryo quality will be assessed with oocytes obtained from both devices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

Inclusion Criteria:

• Donor: =36 years old on day of oocyte retrieval

• Donor: = 6 mature oocytes

Exclusion Criteria:

• Donor: < 6 mature oocytes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embryo Quality
• Survival

Intervention

Device:
• CBSvit HS device
closed vitrification with closed storage
• Cryotop SC device
open vitrification with closed storage

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	The purpose is to assess the survival rate of donor oocytes with the two vitrification devices.	up to 6 days after every warming cycle	No
Secondary	Embryo development	The purpose is to analyse the pre-implantation development of donor oocytes vitrified with two different devices.	up to 6 days after every warming cycle	No