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CompletedNCT01952184Updated Dec 3, 2015

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

An interventional study of CBSvit HS device and Cryotop SC device in Survival and Embryo Quality, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-03.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 36 Years
Sex
Female
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Survival
  • Embryo Quality

Keywords

  • vitrification
  • oocyte
  • donor
  • open
  • closed
03

In context

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 36 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Donor: ≤36 years old on day of oocyte retrieval
  • Donor: ≥ 6 mature oocytes

Exclusion criteria

Exclusion Criteria:

  • Donor: \< 6 mature oocytes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Active comparator
    closed vitrification with closed storage

    Half of the oocytes of every donor will be vitrified with the Cryo Bio Systems High Security vitrification (CBSvit HS) device; the standard device in our lab.

    Device: CBSvit HS device

  • Experimental
    open vitrification with closed storage

    Half of the oocytes of every donor will be vitrified with the Cryotop closed system (Cryotop SC).

    Device: Cryotop SC device

Interventions

  • DeviceCBSvit HS device

    closed vitrification with closed storage

  • DeviceCryotop SC device

    open vitrification with closed storage

06

What researchers measure

Primary outcomes

  1. Survival rate

    The purpose is to assess the survival rate of donor oocytes with the two vitrification devices.

    Time frame: up to 6 days after every warming cycle

Secondary outcomes

  1. Embryo development

    The purpose is to analyse the pre-implantation development of donor oocytes vitrified with two different devices.

    Time frame: up to 6 days after every warming cycle

07

Study locations

1 site
  • Universitair Ziekenhuis Brussel
    Jette, Brussels 1090, Belgium
08

References and documents

Publications

  • De Munck N, Santos-Ribeiro S, Stoop D, Van de Velde H, Verheyen G. Open versus closed oocyte vitrification in an oocyte donation programme: a prospective randomized sibling oocyte study. Hum Reprod. 2016 Feb;31(2):377-84. doi: 10.1093/humrep/dev321. Epub 2016 Jan 2. PubMed 26724798 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01952184
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Neelke De Munck (MSc., Universitair Ziekenhuis Brussel) — Principal investigator
First posted
Sep 27, 2013
Start date
Sep 2013
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Dec 3, 2015

Study contacts

Neelke De Munck, MSc.
principal investigator · Centrum voor Reproductieve Geneeskunde, UZBrussel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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