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

University Hospital, Clermont-Ferrand

Status: Unknown

Conditions: Fertility; Cancer

Treatments: Other: Gavi , Merck® (automated vitrification instrument); Other: Vitrification

Study type: Observational

Funder types: Other

Identifiers

NCT03680937

CHU-393

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICSI treatment
• Immature oocytes
• Without ovulation pathologies

Exclusion criteria

• Polykistic ovarian syndrome
• Endometriosis
• Ovulatory disease

Trial design

240 participants in 3 patient groups

Immature oocytes vitrified before in vitro maturation

Description:

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

Treatment:

Other: Gavi , Merck® (automated vitrification instrument)

Other: Vitrification

Immature oocytes vitrified after in vitro maturation

Description:

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.

Treatment:

Other: Gavi , Merck® (automated vitrification instrument)

Other: Vitrification

Fresh oocytes

Description:

The culture of immature oocytes will be performed during 36 hours