NCT03416400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 24, 2018

Last Update Submit

January 31, 2018

Conditions

Oocytes Vitrified at Prophase-I StageOocytes Matured in Vitro

Keywords

VitrificationIn vitro maturationCytoskeletonchromosomesHigh resolution imaging

Outcome Measures

Primary Outcomes (1)

  • Analysis of maturation kinetic of oocytes vitrified at Prophase-I stage compared to fresh oocytes

    After oocytes retrieval, immature oocytes will be vitrified (Rapid Vit Ovocyte®, Vitrolife) in a closed system (Rapid-I®, Vitrolife) and thawed for in vitro maturation few days after. The meiotic process will be analyzed by time lapse technology (Primovision®, Vitrolife). This will permit to score the time of maturation from resumption to polar body extrusion of ovocytes.

    at day 1

Secondary Outcomes (4)

  • Analysis of actin and tubulin cytoskeleton at Metaphase-II stage

    at day 1

  • Analysis of chromosome segregation during the first meiotic division.

    at day 1

  • Analysis of cortical granules distribution in Metaphase-II stage oocytes.

    at day 1

  • Analysis of maternal factor stabilities.

    at day 1

Study Arms (3)

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

Other: Oocyte vitrification

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.

Other: Oocyte vitrification

Fresh oocytes

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

Other: Oocyte vitrification

Interventions

Oocyte vitrificationOTHER

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 oocytesImmature oocytes cultured in vitro before vitrificationImmature oocytes vitrified before In Vitro Maturation

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

female

You may qualify if:

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

You may not qualify if:

  • \- Polyckistic Ovarian Syndrome
  • Endometriosis
  • Ovulatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 31, 2018

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

December 31, 2019

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

FR(1)