Comparison of Vitrification Effect Before or After In Vitro Maturation

NCT ID: NCT03416400

Last Updated: 2018-02-01

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-31

Brief Summary

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Human oocyte cryopreservation is routinely used for fertility preservation of women who will be exposed to gonadotoxic effect of cancer treatment. After ovarian stimulation, matured oocytes are vitrified. However, this strategy cannot always be used, particularly for hormone-sensitive cancer or when ovarian stimulation is not possible. An approach including immature oocytes and in vitro maturation (IVM) could be considered in these cases. While some qualitative analysis of oocytes vitrified before or after IVM suggest that vitrification should be performed after IVM, little is known about vitrification effects on actin and tubulin cytoskeleton and kinetic of maturation of human ovocytes.

To answer to this question, Investigator performed quantitive analyses comparing matured oocytes from three different groups: vitrified before IVM or after IVM and non-vitrified oocytes. Non-vitrified matured oocytes were used as a control. Different parameters have been analysed during maturation and in matured oocytes.

Detailed Description

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Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system ("Vitrolife"). Kinetic of maturation were analyzed by Primovision ("Vitrolife") and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

Conditions

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Oocytes Vitrified at Prophase-I Stage Oocytes Matured in Vitro

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 were vitrified using closed system vitrification. After warming, they were cultured during 36 hours in IVM medium and fixed for cellular analysis

Oocyte vitrification

Intervention Type OTHER

Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system (Vitrolife). Kinetic of maturation were analyzed by Primovision (Vitrolife) and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

Immature oocytes cultured in vitro before vitrification

Immature oocytes were cultured in vitro in IVM medium during 36 hours. After IVM, they were vitrified. After warming, they were fixed for cellular analysis.

Oocyte vitrification

Intervention Type OTHER

Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system (Vitrolife). Kinetic of maturation were analyzed by Primovision (Vitrolife) and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

Fresh oocytes

Immature oocytes were cultured in vitro in IVM medium during 36 hours and subsequently, fixed for cellular analysis.

Oocyte vitrification

Intervention Type OTHER

Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system (Vitrolife). Kinetic of maturation were analyzed by Primovision (Vitrolife) and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

Interventions

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Oocyte vitrification

Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system (Vitrolife). Kinetic of maturation were analyzed by Primovision (Vitrolife) and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \- ICSI treatment
* Immature oocytes
* \< 37 years old

Exclusion Criteria

* \- Polyckistic Ovarian Syndrome
* Endometriosis
* Ovulatory disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Origio A/S

INDUSTRY

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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CHU-372

Identifier Type: -

Identifier Source: org_study_id

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