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

Cancer Clinical Trial

— OVOMIV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03680937
• Other study ID #: CHU-393
• Status: Not yet recruiting
• Start date: September 20, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: July 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

Inclusion Criteria:

• ICSI treatment

• Immature oocytes

• Without ovulation pathologies

Exclusion Criteria:

• Polykistic ovarian syndrome

• Endometriosis

• Ovulatory disease

Related Conditions & MeSH terms

• Cancer
• Fertility

Intervention

Other:
• Gavi , Merck® (automated vitrification instrument)
Gavi, Merck ® permits semi-automated vitrification with closed system.
• 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).

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The embryonic development kinetics	from the records obtained with Time Lapse Primovision, investigator will be able to determine the precise times of embryonic development after in vitro maturation.	6 days after ICSI and through study completion
Secondary	Analysis of actin and tubulin cytoskeleton and spindle organization in mature ovocytes (Metaphase II)	Metaphase-II stage oocytes will be used for Immuno-Fluorescence experiments to stain actin, tubulin and chromosomes. Oocytes will be imaged using confocal microscope to perform high resolution imaging and quantitative image analysis. The length, position and orientation of the second meiotic spindle will be analysed. The actin network and chromosomes will be analysed quantitatively. All measurements will be compared with fresh matured (Metaphase-II) oocytes used as a control group.	01/01/2019 - 31/12/2019
Secondary	Analysis of chromosome segregation during the first meiotic division	A multi Fluorescence in Situ Hybridization and/or a CGH array will be performed to measure the chromosome segregation after vitrification	01/01/2019 - 31/12/2019
Secondary	Analysis of cortical granules distribution in mature (Metaphase II) oocytes.	A staining with Lectin will be used to mark cortical granules of matured oocytes to observe whether the protocol has an impact on their spatial distribution. To analyse this staining, investigator will use quantitative image analysis method.	01/01/2019 - 31/12/2019
Secondary	Analysis of maternal factor stabilities.	Maternal factors stored in the oocyte cytoplasm during oogenesis as proteins and transcripts are essential for the early embryonic development. Investigator will perform Reverse Transcription combined with Real Time PCR to quantify transcript amounts of candidates genes selected from human oocytes databases.	01/01/2019 - 31/12/2019