NCT03570073

Brief Summary

In the space of a few decades, oocyte cryopreservation has become established in the world of reproductive biology with the authorization of oocyte vitrification. This ultra-fast manual freezing technique (authorised in France since 2011) is mainly used to preserve oocytes in women who have to undergo a treatment that could potentially cause sterility. A clear improvement in survival rates since the early stages of slow freezing has been observed with vitrification but with fairly heterogeneous results Indeed, manual vitrification remains an operator-dependent technique with a long learning curve and which does not allow an oocyte survival rate of more than 70-80%. The recent marketing of an automatic vitrification machine would make it possible to standardise the whole vitrification process from the contact/exchange of fluids to the sealing of the units, and thus potentially increase the oocyte survival rate. It seems to be in the best interest of women that their ability to conceive be preserved (probably for several years) with the technique that offers the best survival and reproducibility rates. However, no studies have been conducted to assess the impact of such automation on oocyte survival. For this reason the investigators wish to set up a comparative study between the routine, manual technique, and an automated technique (GAVI system), using immature oocytes, not suitable for fertilization, and usually discarded.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

June 26, 2018

Status Verified

April 1, 2018

Enrollment Period

2.6 years

First QC Date

June 5, 2018

Last Update Submit

June 15, 2018

Conditions

Automatic VitrificationManual Vitrification

Outcome Measures

Primary Outcomes (2)

  • absence of post-thaw oocyte lysis

    At warming

  • absence of post-thaw oocyte lysis

    3 hours after warming

Study Arms (2)

Manual vitrification

ACTIVE COMPARATOR
Other: Manual vitrification

Automatic vitrification

EXPERIMENTAL
Other: Vitrification with GaviTM system

Interventions

Manual vitrificationOTHER

Two oocytes will be frozen by vitrification. At thawing, the degree of rehydration objectified by the measurement of oocyte surfaces and the appearance of potential lysis will be studied thanks to culture in the embryoscope.

Manual vitrification
Vitrification with GaviTM systemOTHER

Two oocytes will be frozen by vitrification. At thawing, the degree of rehydration objectified by the measurement of oocyte surfaces and the appearance of potential lysis will be studied thanks to culture in the embryoscope.

Automatic vitrification

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be:
  • Adult
  • Affiliated to a National Health System
  • Informed about the study and having given consent
  • Receiving an in vitro fertilization attempt with microinjection (ICSI, IntraCytoplasmic Sperm Injection) or having agreed to donate oocytes after approval by the Multidisciplinary Committee
  • Having more than two immature, non-fertile oocytes on the day the oocytes are retrieved,
  • Having at least two mature oocytes at the end of a 24-hour maturation in vitro.

You may not qualify if:

  • Protected patient, under guardianship or trusteeship
  • In Vitro Fertilization (IVF) Attempts
  • Attempts at IVF or ICSI performed in the context of viral risk (both systems will be frozen in the same nitrogen tanks in the assisted reproduction laboratory)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

RECRUITING

Related Publications (1)

  • Barberet J, Ducreux B, Bruno C, Guilleman M, Simonot R, Lieury N, Guilloteau A, Bourc'his D, Fauque P. Comparison of oocyte vitrification using a semi-automated or a manual closed system in human siblings: survival and transcriptomic analyses. J Ovarian Res. 2022 Dec 5;15(1):128. doi: 10.1186/s13048-022-01064-3.

    PMID: 36464714DERIVED

MeSH Terms

Interventions

Vitrification

Intervention Hierarchy (Ancestors)

Phase TransitionPhysical Phenomena

Central Study Contacts

Julie BARBERET

CONTACT

0380295101julie.barberet@chu-dijon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 26, 2018

Study Start

January 1, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

June 26, 2018

Record last verified: 2018-04

Locations

FR(1)