NCT02940106

Brief Summary

This randomized pilot study will assess if there is a difference in clinical pregnancies using donor oocytes cryopreserved in either a closed or a semi-closed vitrification device.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

October 11, 2016

Last Update Submit

January 10, 2022

Conditions

Infertility

Keywords

oocyte cryopreservationclosed vitrificationopen vitrification

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    Pregnancy determined by ultrasound

    7 weeks

Secondary Outcomes (3)

  • survival

    1 week

  • fertilization

    1 week

  • embryo development

    2 weeks

Study Arms (2)

closed device

PLACEBO COMPARATOR

Standard cryopreservation system.

Device: CBSvit device

open device

ACTIVE COMPARATOR

New cryopreservation system.

Device: Cryotop device

Interventions

Cryotop deviceDEVICE

a different device for oocyte vitrification (with a very high cooling rate)

Also known as: Cryotop open vitrification device (Kitazato)
open device
CBSvit deviceDEVICE

a different device for oocyte vitrification (with a lower cooling rate)

Also known as: CBSvit closed vitrification device (CryoBioSystems vitrification device)
closed device

Eligibility Criteria

Age18 Years - 47 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • this is a pragmatic randomized clinical trial. Hence, all consenting oocyte recipients will be eligible for the study

You may not qualify if:

  • women who do not consent or that cannot comprehend the investigational nature of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 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: 26724798BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Neelke De Munck, MSc.

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in Science

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 20, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

BE(1)