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

NCT ID: NCT01952184

Last Updated: 2015-12-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Survival Embryo Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CBSvit HS device

Intervention Type DEVICE

closed vitrification with closed storage

open vitrification with closed storage

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

Group Type EXPERIMENTAL

Cryotop SC device

Intervention Type DEVICE

open vitrification with closed storage

Interventions

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CBSvit HS device

closed vitrification with closed storage

Intervention Type DEVICE

Cryotop SC device

open vitrification with closed storage

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Donor: \< 6 mature oocytes
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 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

MSc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neelke De Munck, MSc.

Role: PRINCIPAL_INVESTIGATOR

Centrum voor Reproductieve Geneeskunde, UZBrussel

Locations

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Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 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 DERIVED
PMID: 26724798 (View on PubMed)

Other Identifiers

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2013/777

Identifier Type: -

Identifier Source: org_study_id