Clinical trial NCT03416400: Comparison of Vitrification Effect Before or After In Vitro Maturation
Official title: Characterization of a Method of Fertility Preservation for Patients Diagnosed for a Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oocytes Vitrified at Prophase-I Stage
Oocytes Matured in Vitro
Keywords: Vitrification
In vitro maturation
Cytoskeleton
chromosomes
High resolution imaging
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Origio A/S
First posted: 2018-01-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* - Polyckistic Ovarian Syndrome
* Endometriosis
* Ovulatory disease

Primary outcomes:
measure: Analysis of maturation kinetic of oocytes vitrified at Prophase-I stage compared to fresh oocytes
timeFrame: at day 1
Secondary outcomes:
measure: Analysis of actin and tubulin cytoskeleton at Metaphase-II stage
timeFrame: at day 1
measure: Analysis of chromosome segregation during the first meiotic division.
timeFrame: at day 1
measure: Analysis of cortical granules distribution in Metaphase-II stage oocytes.
timeFrame: at day 1
measure: Analysis of maternal factor stabilities.
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: