Methods for Fertility Preservation: Impact of Vitrification on in Vitro Matured Oocytes

NCT ID: NCT03680937

Last Updated: 2018-09-21

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

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-20

Study Completion Date

2020-07-31

Brief Summary

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During the last decades, there was an improvement of the cancer treatments of the woman and the teenagers. Therefore higher survival rate is described. However, cancer treatments can alter the reproduction functions and reduce considerably the window of the fertility to the adulthood. Therefore, it is recommended to proceed to a fertility preservation by oocytes vitrification when it is possible. The vitrification is a freezing technique allowing high survival rate and similar results by assisted reproductive technologies compared with the use of fresh oocytes. An innovative method of automated vitrification was recently developed. The usual protocol consist to vitrify mature oocytes. However, this strategy cannot be used for hormone -sensitive cancer or when ovarian stimulation is not possible. In these situations, immature oocytes can be collected. It is also necessary to realize an in vitro maturation step for a use by assisted reproductive technology.

According to the recent data of the literature, it remains unclear whether the vitrification of ovocytes must be performed before or after in vitro maturation (IVM). Therefore the aim of this study is to study the impact on structure and functions of ovocytes when vitrification is performed before or after IVM. The vitrification will be performed by a semi-automatic method which is an innovative method.

Detailed Description

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To perform this study, investigator will compare three groups. Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).

The immature oocytes provide from ICSI patients. In routine these oocytes (germinal vesicle) are normally destroyed because they cannot be used for injection. The women will give an informed and written consent. Inclusion criteria are women less 37 years without dysovulation.

The vitrification will be performed with the semi-automatic method (Gavi, Merck). The kinetic and maturation rate will be analysed by time lapse (Primovision, Vitrolife) In the mature oocytes, the actin and tubulin cytoskeleton, the spindle organization and the cortical granules will be studied by immunofluorescence and 3D confocal microscopy. The expression of maternal factors transcription will be analyzed by RT-PCR. The ploidy will be analysed by multiFISH and/or CGH array.

Conditions

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Fertility Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Immature oocytes vitrified before in vitro maturation

Immature oocytes will be vitrified using closed system vitrification with a semiautomatic method. After warming, a maturation culture will be performed during 36 hours

Gavi , Merck® (automated vitrification instrument)

Intervention Type OTHER

Gavi, Merck ® permits semi-automated vitrification with closed system.

Vitrification

Intervention Type OTHER

Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).

Immature oocytes vitrified after in vitro maturation

A maturation culture of immature oocytes will be performed in vitro during 36 hours. After IVM, mature oocytes will be vitrify in closed system by a semi-automatic method.

Gavi , Merck® (automated vitrification instrument)

Intervention Type OTHER

Gavi, Merck ® permits semi-automated vitrification with closed system.

Vitrification

Intervention Type OTHER

Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).

Fresh oocytes

The culture of immature oocytes will be performed during 36 hours

No interventions assigned to this group

Interventions

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Gavi , Merck® (automated vitrification instrument)

Gavi, Merck ® permits semi-automated vitrification with closed system.

Intervention Type OTHER

Vitrification

Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ICSI treatment
* Immature oocytes
* Without ovulation pathologies

Exclusion Criteria

* Polykistic ovarian syndrome
* Endometriosis
* Ovulatory disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence BRUGNON

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

0473751195

Facility Contacts

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Patrick LACARIN

Role: primary

0473751195

References

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Chaput L, Dollet S, Eymard-Pierre E, Pereira B, Lucas C, Gremeau AS, Tchirkov A, Marteil G, Brugnon F. Analysis of maturation dynamics and oocyte nuclear quality after rescue-IVM and semi-automated vitrification. Hum Reprod. 2025 Jul 1;40(7):1344-1356. doi: 10.1093/humrep/deaf078.

Reference Type DERIVED
PMID: 40373183 (View on PubMed)

Other Identifiers

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CHU-393

Identifier Type: -

Identifier Source: org_study_id

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