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Interest of Automated Oocyte Freezing

NCT03570073 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-06-26

No results posted yet for this study

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.

Conditions

  • Automatic Vitrification
  • Manual Vitrification

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570073 on ClinicalTrials.gov