Clinical Pregnancies After Cryopreservation of Donor Oocytes With an Open or Closed Device

NCT ID: NCT02940106

Last Updated: 2022-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Oocyte cryopreservation was optimized by the use of a new technique: vitrification. Vitrification can be performed using either open devices (where the oocytes are in direct contact with the liquid nitrogen) or closed systems (where the oocytes are never in contact with liquid nitrogen). Previous studies have associated the use of open devices to higher oocyte survival rates and better embryo development. However, any beneficial effect on clinical pregnancy rates is yet to be proven. Hence, the objective of this study is to compare the clinical pregnancy rates of open and closed oocyte vitrification devices.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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closed device

Standard cryopreservation system.

Group Type PLACEBO_COMPARATOR

CBSvit device

Intervention Type DEVICE

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

open device

New cryopreservation system.

Group Type ACTIVE_COMPARATOR

Cryotop device

Intervention Type DEVICE

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

Interventions

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Cryotop device

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

Intervention Type DEVICE

CBSvit device

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

Intervention Type DEVICE

Other Intervention Names

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Cryotop open vitrification device (Kitazato) CBSvit closed vitrification device (CryoBioSystems vitrification device)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* women who do not consent or that cannot comprehend the investigational nature of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

47 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Neelke De Munck

Master in Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neelke De Munck, MSc.

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 26724798 (View on PubMed)

Other Identifiers

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2016/245

Identifier Type: -

Identifier Source: org_study_id

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