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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01952184
Other study ID # 2013/777
Secondary ID
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


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
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