Interest of Automated Oocyte Freezing

NCT ID: NCT03570073

Last Updated: 2018-06-26

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Automatic Vitrification Manual Vitrification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Manual vitrification

Group Type ACTIVE_COMPARATOR

Manual vitrification

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Vitrification with GaviTM system

Intervention Type OTHER

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.

Interventions

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Manual vitrification

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.

Intervention Type OTHER

Vitrification with GaviTM system

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julie BARBERET

Role: CONTACT

0380295101

Facility Contacts

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Julie BARBERET

Role: primary

0380295101

References

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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.

Reference Type DERIVED
PMID: 36464714 (View on PubMed)

Other Identifiers

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Barberet AOI 2017

Identifier Type: -

Identifier Source: org_study_id

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