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

NCT03680937 | Unknown

• 1 other identifier: CHU-393
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fertility; Cancer

Keywords

Vitrification; In vitro maturation; time lapse; High resolution imaging; quantitative molecular analysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Analysis of actin and tubulin cytoskeleton and spindle organization in mature ovocytes (Metaphase II)

  01/01/2019 - 31/12/2019

• Analysis of chromosome segregation during the first meiotic division

  01/01/2019 - 31/12/2019

• Analysis of cortical granules distribution in mature (Metaphase II) oocytes.

  01/01/2019 - 31/12/2019

• Analysis of maternal factor stabilities.

  01/01/2019 - 31/12/2019

Study Arms (3)

Immature oocytes vitrified before in vitro maturation

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

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

Immature oocytes vitrified after in vitro maturation

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.

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

Fresh oocytes

The culture of immature oocytes will be performed during 36 hours

Interventions

Gavi , Merck® (automated vitrification instrument) OTHER

Gavi, Merck ® permits semi-automated vitrification with closed system.

Immature oocytes vitrified after in vitro maturation; Immature oocytes vitrified before in vitro maturation

Vitrification OTHER

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).

Immature oocytes vitrified after in vitro maturation; Immature oocytes vitrified before in vitro maturation

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women

You may qualify if:

• ICSI treatment
• Immature oocytes
• Without ovulation pathologies

You may not qualify if:

• Polykistic ovarian syndrome
• Endometriosis
• Ovulatory disease

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• Chaput L, Dollet S, Eymard-Pierre E, Pereira B, Lucas C, Gremeau AS, Tchirkov A, Marteil G, Brugnon F. Analysis of maturation dynamics and oocyte nuclear quality after rescue-IVM and semi-automated vitrification. Hum Reprod. 2025 Jul 1;40(7):1344-1356. doi: 10.1093/humrep/deaf078.

  PMID: 40373183 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Vitrification

Intervention Hierarchy (Ancestors)

Phase Transition; Physical Phenomena

Study Officials

• Florence BRUGNON

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

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

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: September 21, 2018
• Study Start: September 20, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 31, 2020
• Last Updated: September 21, 2018

Record last verified: 2018-09

Locations

FR (1)