NCT01952184

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

September 24, 2013

Last Update Submit

December 2, 2015

Conditions

SurvivalEmbryo Quality

Keywords

vitrificationoocytedonoropenclosed

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Embryo development

    up to 6 days after every warming cycle

Study Arms (2)

closed vitrification with closed storage

ACTIVE COMPARATOR

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

open vitrification with closed storage

EXPERIMENTAL

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

Device: Cryotop SC device

Interventions

CBSvit HS deviceDEVICE

closed vitrification with closed storage

closed vitrification with closed storage
Cryotop SC deviceDEVICE

open vitrification with closed storage

open vitrification with closed storage

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Donor: \< 6 mature oocytes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 26724798DERIVED

Study Officials

  • Neelke De Munck, MSc.

    Centrum voor Reproductieve Geneeskunde, UZBrussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc.

Study Record Dates

First Submitted

September 24, 2013

First Posted

September 27, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

BE(1)